Trial Outcomes & Findings for A Study to Evaluate the Safety, Efficacy and Changes in Induced Sputum and Blood Biomarkers Following Daily Repeat Doses of Inhaled GSK2269557 in Chronic Obstructive Pulmonary Disease (COPD) Subjects With Acute Exacerbation (NCT NCT02522299)
NCT ID: NCT02522299
Last Updated: 2021-09-05
Results Overview
Saline-induced sputum samples were collected at the indicated time-points to determine the alterations in previously identified immune cell mechanisms specifically related to neutrophil function by identifying the changes in mRNA transcriptome in induced sputum. Baseline was defined as screening visit. The log2 transformed mRNA intensities for each probe set were analyzed in a separate repeated measures model. Back transformed baseline-adjusted ratios and two-sided unadjusted p-values were calculated for each visit as the specified time-point value/baseline value. These ratios were converted to fold change values; if ratio \>= 1 then fold change=ratio or if ratio \< 1 then fold change = -1/ratio. Data for pre-specified probe sets that meet the criteria fold change \>1.5 or \<-1.5 and p\<0.05 for All NEMI, All Placebo and All NEMI/All Placebo group is presented in outcome measure 1, 2 and 3 respectively. In the categories column we have included time-point, Probe ID and Gene label.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
44 participants
Primary outcome timeframe
Baseline (Screening) and Days 12, 28 and 84
Results posted on
2021-09-05
Participant Flow
A total 44 participants with Chronic obstructive pulmonary disease (COPD) were enrolled in this study. The study had a protocol amendment to reflect changes in manufacturing device from DISKUS to ELLIPTA.but the 2 treatment arms remained the same i.e. Placebo and GSK2269557 (Nemiralisib \[NEMI\]).There was no intent to compare two devices.
As the switch to the ELLIPTA device was intended to be a comparable treatment, the treatment groups Placebo DISKUS and Placebo ELLIPTA were combined as All Placebo treatment group. Similarly, the treatment groups NEMI DISKUS and NEMI ELLIPTA were combined as All NEMI treatment group.
Participant milestones
| Measure |
All Placebo
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using DISKUS or ELLIPTA dry powder inhaler (DPI).
|
All NEMI
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
22
|
|
Overall Study
COMPLETED
|
18
|
21
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
All Placebo
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using DISKUS or ELLIPTA dry powder inhaler (DPI).
|
All NEMI
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
A Study to Evaluate the Safety, Efficacy and Changes in Induced Sputum and Blood Biomarkers Following Daily Repeat Doses of Inhaled GSK2269557 in Chronic Obstructive Pulmonary Disease (COPD) Subjects With Acute Exacerbation
Baseline characteristics by cohort
| Measure |
All Placebo
n=22 Participants
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using DISKUS or ELLIPTA dry powder inhaler (DPI).
|
All NEMI
n=22 Participants
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.0 Years
STANDARD_DEVIATION 8.20 • n=5 Participants
|
66.1 Years
STANDARD_DEVIATION 7.32 • n=7 Participants
|
65.1 Years
STANDARD_DEVIATION 7.75 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Screening) and Days 12, 28 and 84Population: All Subjects Population comprised of all randomized participants who received at least one dose of the study treatment.
Saline-induced sputum samples were collected at the indicated time-points to determine the alterations in previously identified immune cell mechanisms specifically related to neutrophil function by identifying the changes in mRNA transcriptome in induced sputum. Baseline was defined as screening visit. The log2 transformed mRNA intensities for each probe set were analyzed in a separate repeated measures model. Back transformed baseline-adjusted ratios and two-sided unadjusted p-values were calculated for each visit as the specified time-point value/baseline value. These ratios were converted to fold change values; if ratio \>= 1 then fold change=ratio or if ratio \< 1 then fold change = -1/ratio. Data for pre-specified probe sets that meet the criteria fold change \>1.5 or \<-1.5 and p\<0.05 for All NEMI, All Placebo and All NEMI/All Placebo group is presented in outcome measure 1, 2 and 3 respectively. In the categories column we have included time-point, Probe ID and Gene label.
Outcome measures
| Measure |
All NEMI
n=22 Participants
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
All NEMI
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
Placebo Via ELLIPTA
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
NEMI 700 mcg Via ELLIPTA
Participants were administered with NEMI 700 mcg once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
|---|---|---|---|---|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group
Day 84, 234212_at, ACTR2
|
-1.57 Fold change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group
Day 12,222834_s_at, GNG12
|
1.78 Fold change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group
Day 12,210390_s_at, CCL15
|
1.72 Fold change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group
Day 12,212294_at, GNG12
|
1.67 Fold change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group
Day 12,226497_s_at, FLT1
|
1.57 Fold change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group
Day 12, 204356_at, LIMK1
|
1.54 Fold change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group
Day 12, 203923_s_at, CYBB
|
1.51 Fold change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group
Day 12, 219748_at, TREML2
|
-1.51 Fold change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group
Day 12, 1555086_at, STAT5B
|
-1.51 Fold change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group
Day 12, 211883_x_at, CEACAM1
|
-1.51 Fold change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group
Day 12, 224909_s_at, PREX1
|
-1.51 Fold change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group
Day 12, 239170_at, ACTR3
|
-1.51 Fold change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group
Day 12, 212550_at, STAT5B
|
-1.52 Fold change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group
Day 12, 202178_at, PRKCZ
|
-1.52 Fold change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group
Day 12, 219633_at, TTPAL
|
-1.53 Fold change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group
Day 12, 204285_s_at, PMAIP1
|
-1.56 Fold change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group
Day 12, 1555088_x_at, STAT5B
|
-1.56 Fold change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group
Day 12, 227817_at, PRKCB
|
-1.57 Fold change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group
Day 12, 205632_s_at, PIP5K1B
|
-1.58 Fold change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group
Day 12, 202018_s_at, LTF
|
-1.59 Fold change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group
Day 12, 232763_at, TLN1
|
-1.59 Fold change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group
Day 12, 202948_at, IL1R1
|
-1.60 Fold change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group
Day 12, 1569830_at, PTPRC
|
-1.63 Fold change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group
Day 12, 215561_s_at, IL1R1
|
-1.69 Fold change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group
Day 12, 228031_at, TTPAL
|
-1.71 Fold change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group
Day 12, 209498_at, CEACAM1
|
-1.75 Fold change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group
Day 12, 204563_at, SELL
|
-1.87 Fold change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group
Day 12, 205118_at, FPR1
|
-1.93 Fold change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group
Day 12, 236172_at, LTB4R
|
-1.96 Fold change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group
Day 12, 212372_at, MYH10
|
-2.12 Fold change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group
Day 28, 244313_at, CR1
|
1.99 Fold change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group
Day 28, 213093_at, PRKCA
|
1.53 Fold change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group
Day 28, 205778_at, KLK7
|
-1.54 Fold change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group
Day 84, 233694_at, HSPA1L
|
1.88 Fold change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group
Day 84, 208304_at, CCR3
|
1.83 Fold change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group
Day 84, 215101_s_at, CXCL5
|
1.82 Fold change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group
Day 84,214974_x_at ,CXCL5
|
1.80 Fold change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group
Day 84, 207852_at, CXCL5
|
1.63 Fold change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group
Day 84, 1555759_a_at, CCL5
|
-1.51 Fold change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group
Day 84, 207535_s_at, NFKB2
|
-1.53 Fold change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group
Day 84, 207794_at, CCR2
|
-1.58 Fold change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group
Day 84, 206978_at, CCR2
|
-1.64 Fold change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group
Day 84, 211889_x_at, CEACAM1
|
-1.69 Fold change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group
Day 84, 206219_s_at, VAV1
|
-1.71 Fold change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group
Day 84, 209498_at, CEACAM1
|
-1.72 Fold change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group
Day 84, 206576_s_at, CEACAM1
|
-1.75 Fold change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group
Day 84, 211883_x_at, CEACAM1
|
-1.76 Fold change
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Screening) and Days 12, 28 and 84Population: All Subjects Population.
Saline-induced sputum samples were collected at the indicated time-points to determine the alterations in previously identified immune cell mechanisms specifically related to neutrophil function by identifying the changes in mRNA transcriptome in induced sputum. Baseline was defined as screening visit. The log2 transformed mRNA intensities for each probe set were analysed in a separate repeated measures model. Back transformed baseline-adjusted ratios and two-sided unadjusted p-values were calculated for each visit as the specified time-point value/baseline value. These ratios were converted to fold change values; if ratio \>= 1 then fold change=ratio or if ratio \< 1 then fold change = -1/ratio. Data for pre-specified probe sets that meet the criteria fold change \>1.5 or \<-1.5 and p\<0.05 for All NEMI, All Placebo and All NEMI/All Placebo group is presented in outcome measure 1, 2 and 3 respectively. In the categories column we have included time-point, Probe ID and Gene label.
Outcome measures
| Measure |
All NEMI
n=22 Participants
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
All NEMI
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
Placebo Via ELLIPTA
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
NEMI 700 mcg Via ELLIPTA
Participants were administered with NEMI 700 mcg once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
|---|---|---|---|---|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 12, 227404_s_at, EGR1
|
-1.51 Fold Change
|
—
|
—
|
—
|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 12, 1552552_s_at,CLEC4C
|
-1.54 Fold Change
|
—
|
—
|
—
|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 84,232068_s_at,TLR4
|
-1.77 Fold Change
|
—
|
—
|
—
|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 84,221060_s_at,TLR4
|
-1.78 Fold Change
|
—
|
—
|
—
|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 84,201601_x_at,IFITM1
|
-1.79 Fold Change
|
—
|
—
|
—
|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 84,202018_s_at,LTF
|
-1.82 Fold Change
|
—
|
—
|
—
|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 12, 222834_s_at, GNG12
|
2.29 Fold Change
|
—
|
—
|
—
|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 12, 207852_at, CXCL5
|
1.81 Fold Change
|
—
|
—
|
—
|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 12, 212294_at, GNG12
|
1.79 Fold Change
|
—
|
—
|
—
|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 12, 209576_at, GNAI1
|
1.61 Fold Change
|
—
|
—
|
—
|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 12, 211823_s_at,PXN
|
-1.55 Fold Change
|
—
|
—
|
—
|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 12,206978_at,CCR2
|
-1.55 Fold Change
|
—
|
—
|
—
|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 12,206219_s_at,VAV1
|
-1.56 Fold Change
|
—
|
—
|
—
|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 12,219748_at,TREML2
|
-1.56 Fold Change
|
—
|
—
|
—
|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 12,207794_at,CCR2
|
-1.58 Fold Change
|
—
|
—
|
—
|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 12,211561_x_at,MAPK14
|
-1.59 Fold Change
|
—
|
—
|
—
|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 12,226507_at,PAK1
|
-1.59 Fold Change
|
—
|
—
|
—
|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 12,232068_s_at,TLR4
|
-1.60 Fold Change
|
—
|
—
|
—
|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 12,209282_at,PRKD2
|
-1.60 Fold Change
|
—
|
—
|
—
|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 12,226080_at,SSH2
|
-1.61 Fold Change
|
—
|
—
|
—
|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 12,212550_at,STAT5B
|
-1.64 Fold Change
|
—
|
—
|
—
|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 12,212372_at,MYH10
|
-1.64 Fold Change
|
—
|
—
|
—
|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 12,214022_s_at,IFITM1
|
-1.66 Fold Change
|
—
|
—
|
—
|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 12,217484_at,CR1
|
-1.67 Fold Change
|
—
|
—
|
—
|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 12,206244_at,CR1
|
-1.68 Fold Change
|
—
|
—
|
—
|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 12,1552480_s_at,PTPRC
|
-1.68 Fold Change
|
—
|
—
|
—
|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 12,1554114_s_at,SSH2
|
-1.69 Fold Change
|
—
|
—
|
—
|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 12,201601_x_at,IFITM1
|
-1.75 Fold Change
|
—
|
—
|
—
|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 12,205842_s_at,JAK2
|
-1.75 Fold Change
|
—
|
—
|
—
|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 12,228603_at, ACTR3
|
-1.75 Fold Change
|
—
|
—
|
—
|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 12,230100_x_at,PAK1
|
-1.77 Fold Change
|
—
|
—
|
—
|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 12,239307_at,MYH11
|
-1.88 Fold Change
|
—
|
—
|
—
|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 12,223750_s_at,TLR10
|
-1.88 Fold Change
|
—
|
—
|
—
|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 12,208488_s_at,CR1
|
-1.92 Fold Change
|
—
|
—
|
—
|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 12,204563_at,SELL
|
-2.70 Fold Change
|
—
|
—
|
—
|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 28, 222834_s_at,GNG12
|
1.91 Fold Change
|
—
|
—
|
—
|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 84,226498_at,FLT1
|
4.10 Fold Change
|
—
|
—
|
—
|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 84,216598_s_at,CCL2
|
1.75 Fold Change
|
—
|
—
|
—
|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 84,1562439_at,NCOA3
|
1.52 Fold Change
|
—
|
—
|
—
|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 84,201087_at,PXN
|
-1.52 Fold Change
|
—
|
—
|
—
|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 84,224909_s_at,PREX1
|
-1.52 Fold Change
|
—
|
—
|
—
|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 84,211823_s_at,PXN
|
-1.53 Fold Change
|
—
|
—
|
—
|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 84,209615_s_at,PAK1
|
-1.54 Fold Change
|
—
|
—
|
—
|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 84,211561_x_at,MAPK14
|
-1.59 Fold Change
|
—
|
—
|
—
|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 84,203749_s_at,RARA
|
-1.60 Fold Change
|
—
|
—
|
—
|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 84,219748_at,TREML2
|
-1.61 Fold Change
|
—
|
—
|
—
|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 84,207008_at,CXCR2
|
-1.66 Fold Change
|
—
|
—
|
—
|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 84,244313_at,CR1
|
-1.67 Fold Change
|
—
|
—
|
—
|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 84,202530_at,MAPK14
|
-1.69 Fold Change
|
—
|
—
|
—
|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 84,228648_at,LRG1
|
-1.71 Fold Change
|
—
|
—
|
—
|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 84,208488_s_at,CR1
|
-1.71 Fold Change
|
—
|
—
|
—
|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 84,228795_at,PRKCB
|
-1.73 Fold Change
|
—
|
—
|
—
|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 84,1552480_s_at,PTPRC
|
-1.76 Fold Change
|
—
|
—
|
—
|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 84,217209_at,CEACAM3
|
-1.85 Fold Change
|
—
|
—
|
—
|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 84,214022_s_at,IFITM1
|
-1.89 Fold Change
|
—
|
—
|
—
|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 84,217552_x_at,CR1
|
-1.89 Fold Change
|
—
|
—
|
—
|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 84,203591_s_at,CSF3R
|
-1.91 Fold Change
|
—
|
—
|
—
|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 84,205118_at,FPR1
|
-1.92 Fold Change
|
—
|
—
|
—
|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 84,1553297_a_at,CSF3R
|
-1.96 Fold Change
|
—
|
—
|
—
|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 84,204563_at,SELL
|
-2.23 Fold Change
|
—
|
—
|
—
|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 84,219669_at,CD177
|
-2.47 Fold Change
|
—
|
—
|
—
|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 12, 213281_at, JUN
|
1.51 Fold Change
|
—
|
—
|
—
|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 12, 222880_at, AKT3
|
1.51 Fold Change
|
—
|
—
|
—
|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 12, 205026_at, STAT5B
|
-1.50 Fold Change
|
—
|
—
|
—
|
|
Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Day 12, 201783_s_at, RELA
|
-1.50 Fold Change
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Screening) and Days 12, 28 and 84Population: All Subjects Population.
Saline-induced sputum samples were collected at the indicated time-points to determine the alterations in previously identified immune cell mechanisms specifically related to neutrophil function by identifying the changes in mRNA transcriptome in induced sputum. For each probe set, the log2 transformed mRNA intensities were analyzed in separate repeated measures models. The models included a Treatment, Visit and Treatment\*Visit term. The Visit consisted of 4 levels: Screening (Baseline), Day 12, Day 28 and Day 84, and the Treatment consisted of three levels: Null (when Visit = Screening), All Placebo and All NEMI. The fold changes were derived from the back transformed ratio from Baselines as fold change = ratio if ratio is \>=1, else if ratio \<1 then fold change = -1/ratio. Data for pre-specified probe sets that meet the criteria fold change \>1.5 and p\<0.05 for All NEMI, All Placebo and All NEMI/All Placebo group is presented in outcome measure 1, 2 and 3 respectively.
Outcome measures
| Measure |
All NEMI
n=44 Participants
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
All NEMI
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
Placebo Via ELLIPTA
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
NEMI 700 mcg Via ELLIPTA
Participants were administered with NEMI 700 mcg once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
|---|---|---|---|---|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group
Day 12,200671_s_at,SPTBN1
|
-1.74 Fold Change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group
Day 12,226342_at,SPTBN1
|
-1.89 Fold Change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group
Day 12,200672_x_at,SPTBN1
|
-1.60 Fold Change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group
Day 12,209576_at,GNAI1
|
-1.62 Fold Change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group
Day 12,202178_at,PRKCZ
|
-1.55 Fold Change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group
Day 28,244313_at,CR1
|
2.75 Fold Change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group
Day 28,223750_s_at,TLR10
|
2.66 Fold Change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group
Day 28,217552_x_at,CR1
|
2.25 Fold Change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group
Day 28,206244_at,CR1
|
2.01 Fold Change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group
Day 28,208488_s_at,CR1
|
1.95 Fold Change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group
Day 28,232068_s_at,TLR4
|
1.71 Fold Change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group
Day 28,1553297_a_at,CSF3R
|
1.71 Fold Change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group
Day 28,1552798_a_at,TLR4
|
1.68 Fold Change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group
Day 28,223943_s_at,GNG2
|
1.63 Fold Change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group
Day 28,221060_s_at,TLR4
|
1.58 Fold Change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group
Day 28,239695_at,JAK1
|
1.52 Fold Change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group
Day 28,234290_x_at,MYH14
|
-1.52 Fold Change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group
Day 28,1568377_x_at,DEFB124
|
-1.52 Fold Change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group
Day 28,1555765_a_at,GNG4
|
-1.53 Fold Change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group
Day 28,201464_x_at,JUN
|
-1.57 Fold Change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group
Day 28,201465_s_at,JUN
|
-1.68 Fold Change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group
Day 28,239381_at,KLK7
|
-1.69 Fold Change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group
Day 28,205778_at,KLK7
|
-1.71 Fold Change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group
Day 28,213281_at,JUN
|
-1.72 Fold Change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group
Day 84,208304_at,CCR3
|
2.52 Fold Change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group
Day 84,1553297_a_at,CSF3R
|
2.25 Fold Change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group
Day 84,203591_s_at,CSF3R
|
1.98 Fold Change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group
Day 84,221060_s_at,TLR4
|
1.83 Fold Change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group
Day 84,202530_at,MAPK14
|
1.77 Fold Change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group
Day 84,244313_at,CR1
|
1.60 Fold Change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group
Day 84,203872_at,ACTA1
|
1.53 Fold Change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group
Day 84,216944_s_at,ITPR1
|
-1.51 Fold Change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group
Day 84,215195_at,PRKCA
|
-1.66 Fold Change
|
—
|
—
|
—
|
|
Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group
Day 84,226498_at,FLT1
|
-5.18 Fold Change
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Screening), Days 12 and 28Population: All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
siVaw was measured at FRC and TLC. Data was collected at longitudinal time points (Untrimmed data): Baseline (Screening), Day 12 \& Day 28 and at each time point for scan trimmed pairs: SCRD12, SCRD28 \& D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe \& left lower lobe) and 5 Regions (Upper, Lower, Central, Distal \& Total). For Untrimmed data and SCRD12 \& SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analyzed (n=X1, X2 in the category title). This table presents the untrimmed data (in rows with categories containing untrimmed), SCRD12 scan trim pair data (in rows with categories containing Scan Trimmed and Day 12) and SCRD28 scan trim pair data (in rows with categories containing Scan Trimmed and Day 28) only.
Outcome measures
| Measure |
All NEMI
n=22 Participants
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
All NEMI
n=22 Participants
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
Placebo Via ELLIPTA
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
NEMI 700 mcg Via ELLIPTA
Participants were administered with NEMI 700 mcg once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
|---|---|---|---|---|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes
Untrimmed,Left Upper, Day 28,n=16,19
|
1.082 Milliliters per Liter
Interval 0.669 to 1.75
|
1.065 Milliliters per Liter
Interval 0.814 to 1.393
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes
FRC,Untrimmed,Right Lower, Day 28,n=16,19
|
1.241 Milliliters per Liter
Interval 0.841 to 1.831
|
1.031 Milliliters per Liter
Interval 0.816 to 1.302
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes
FRC,Scan Trimmed,Right Upper,Day 12,n=17,16
|
1.020 Milliliters per Liter
Interval 0.854 to 1.217
|
1.038 Milliliters per Liter
Interval 0.88 to 1.225
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes
FRC,Scan Trimmed,Right Upper,Day 28,n=16,18
|
1.027 Milliliters per Liter
Interval 0.838 to 1.258
|
1.030 Milliliters per Liter
Interval 0.924 to 1.147
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes
FRC,Scan Trimmed,Left Upper,Day 12,n=18,17
|
0.970 Milliliters per Liter
Interval 0.798 to 1.18
|
0.993 Milliliters per Liter
Interval 0.857 to 1.151
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes
FRC,Scan Trimmed,Left Upper,Day 28,n=16,19
|
1.008 Milliliters per Liter
Interval 0.779 to 1.304
|
1.053 Milliliters per Liter
Interval 0.937 to 1.184
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes
FRC,Scan Trimmed,Right Middle,Day 12,n=17,16
|
1.294 Milliliters per Liter
Interval 0.904 to 1.852
|
1.008 Milliliters per Liter
Interval 0.856 to 1.188
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes
FRC,Scan Trimmed,Right Middle,Day 28,n=16,18
|
1.071 Milliliters per Liter
Interval 0.773 to 1.484
|
0.973 Milliliters per Liter
Interval 0.865 to 1.093
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes
FRC,Scan Trimmed,Right Lower,Day 12,n=17,17
|
1.025 Milliliters per Liter
Interval 0.873 to 1.204
|
1.029 Milliliters per Liter
Interval 0.858 to 1.236
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes
FRC,Scan Trimmed,Right Lower,Day 28,n=16,19
|
1.032 Milliliters per Liter
Interval 0.872 to 1.222
|
1.042 Milliliters per Liter
Interval 0.924 to 1.174
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes
FRC,Scan Trimmed,Left Lower,Day 12,n=17,17
|
1.012 Milliliters per Liter
Interval 0.894 to 1.145
|
1.032 Milliliters per Liter
Interval 0.886 to 1.201
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes
FRC,Scan Trimmed,Left Lower,Day 28,n=16,19
|
0.973 Milliliters per Liter
Interval 0.862 to 1.097
|
1.062 Milliliters per Liter
Interval 0.974 to 1.157
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes
TLC,Scan Trimmed,Right Upper,Day 12,n=19,17
|
0.991 Milliliters per Liter
Interval 0.908 to 1.08
|
0.999 Milliliters per Liter
Interval 0.876 to 1.141
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes
TLC,Scan Trimmed,Right Upper,Day 28,n=18,19
|
0.951 Milliliters per Liter
Interval 0.87 to 1.04
|
0.964 Milliliters per Liter
Interval 0.86 to 1.081
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes
TLC,Scan Trimmed,Left Upper,Day 12,n=20,18
|
0.954 Milliliters per Liter
Interval 0.897 to 1.014
|
0.968 Milliliters per Liter
Interval 0.852 to 1.101
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes
TLC,Scan Trimmed,Left Upper,Day 28,n=18,20
|
0.935 Milliliters per Liter
Interval 0.86 to 1.017
|
0.950 Milliliters per Liter
Interval 0.872 to 1.035
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes
TLC,Scan Trimmed,Right Middle,Day 12,n=18,17
|
0.958 Milliliters per Liter
Interval 0.835 to 1.099
|
1.008 Milliliters per Liter
Interval 0.891 to 1.14
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes
TLC,Scan Trimmed,Right Middle,Day 28,n=18,19
|
0.969 Milliliters per Liter
Interval 0.837 to 1.122
|
0.900 Milliliters per Liter
Interval 0.815 to 0.994
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes
TLC,Scan Trimmed,Right Lower,Day 12,n=20,18
|
1.054 Milliliters per Liter
Interval 0.936 to 1.187
|
0.963 Milliliters per Liter
Interval 0.853 to 1.087
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes
TLC,Scan Trimmed,Right Lower,Day 28,n=18,20
|
0.952 Milliliters per Liter
Interval 0.848 to 1.068
|
0.899 Milliliters per Liter
Interval 0.814 to 0.993
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes
TLC,Scan Trimmed,Left Lower,Day 12,n=20,18
|
0.967 Milliliters per Liter
Interval 0.911 to 1.026
|
1.004 Milliliters per Liter
Interval 0.887 to 1.136
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes
TLC,Scan Trimmed,Left Lower,Day 28,n=18,20
|
0.953 Milliliters per Liter
Interval 0.852 to 1.066
|
0.950 Milliliters per Liter
Interval 0.868 to 1.04
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes
FRC,Untrimmed,Right Upper,Day 12,n= 17,16
|
0.900 Milliliters per Liter
Interval 0.67 to 1.209
|
1.071 Milliliters per Liter
Interval 0.851 to 1.349
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes
FRC,Untrimmed,Right Upper, Day 28,n=16,18
|
1.001 Milliliters per Liter
Interval 0.72 to 1.39
|
1.073 Milliliters per Liter
Interval 0.917 to 1.255
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes
FRC,Untrimmed,Left Upper, Day 12,n=18,17
|
1.001 Milliliters per Liter
Interval 0.683 to 1.468
|
0.956 Milliliters per Liter
Interval 0.731 to 1.251
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes
FRC,Untrimmed,Right Middle, Day 12,n=17,16
|
1.347 Milliliters per Liter
Interval 0.709 to 2.559
|
1.058 Milliliters per Liter
Interval 0.825 to 1.356
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes
FRC,Untrimmed,Right Middle, Day 28,n=16,18
|
1.118 Milliliters per Liter
Interval 0.696 to 1.797
|
1.007 Milliliters per Liter
Interval 0.815 to 1.244
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes
FRC,Untrimmed,Right Lower, Day 12,n=17,17
|
1.237 Milliliters per Liter
Interval 0.796 to 1.923
|
1.014 Milliliters per Liter
Interval 0.736 to 1.397
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes
FRC,Untrimmed,Left Lower, Day 12,n=17,17
|
0.967 Milliliters per Liter
Interval 0.754 to 1.239
|
1.002 Milliliters per Liter
Interval 0.702 to 1.429
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes
FRC,Untrimmed,Left Lower, Day 28,n=16,19
|
0.815 Milliliters per Liter
Interval 0.59 to 1.125
|
1.142 Milliliters per Liter
Interval 0.945 to 1.381
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes
TLC,Untrimmed,Right Upper,Day 12,n=19,17
|
0.982 Milliliters per Liter
Interval 0.862 to 1.118
|
1.002 Milliliters per Liter
Interval 0.831 to 1.209
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes
TLC,Untrimmed,Right Upper, Day 28,n=18,19
|
0.884 Milliliters per Liter
Interval 0.776 to 1.006
|
0.941 Milliliters per Liter
Interval 0.804 to 1.1
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes
TLC,Untrimmed,Left Upper, Day 12,n=20,18
|
0.955 Milliliters per Liter
Interval 0.861 to 1.059
|
0.942 Milliliters per Liter
Interval 0.789 to 1.125
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes
TLC,Untrimmed,Left Upper, Day 28,n=18,20
|
0.949 Milliliters per Liter
Interval 0.86 to 1.046
|
0.926 Milliliters per Liter
Interval 0.813 to 1.055
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes
TLC,Untrimmed,Right Middle, Day 12,n=18,17
|
0.942 Milliliters per Liter
Interval 0.777 to 1.142
|
0.970 Milliliters per Liter
Interval 0.811 to 1.161
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes
TLC,Untrimmed,Right Middle, Day 28,n=18,19
|
0.691 Milliliters per Liter
Interval 0.475 to 1.005
|
0.892 Milliliters per Liter
Interval 0.784 to 1.014
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes
TLC,Untrimmed,Right Lower, Day 12,n=20,18
|
1.131 Milliliters per Liter
Interval 0.898 to 1.424
|
0.895 Milliliters per Liter
Interval 0.745 to 1.075
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes
TLC,Untrimmed,Right Lower, Day 28,n=18,20
|
0.948 Milliliters per Liter
Interval 0.791 to 1.135
|
0.865 Milliliters per Liter
Interval 0.753 to 0.993
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes
TLC,Untrimmed,Left Lower, Day 12,n=20,18
|
0.982 Milliliters per Liter
Interval 0.885 to 1.089
|
0.989 Milliliters per Liter
Interval 0.831 to 1.178
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes
TLC,Untrimmed,Left Lower, Day 28,n=18,20
|
0.894 Milliliters per Liter
Interval 0.693 to 1.152
|
0.967 Milliliters per Liter
Interval 0.858 to 1.09
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 12) and Day 28Population: All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
siVaw is a measure of the volume in an individual's airway corrected for their lobar volume derived from the high resolution computed tomography (HRCT). It was measured at FRC and TLC. Data was collected at longitudinal time points (Untrimmed data): Baseline (Screening), Day 12 \& Day 28 and at each time point for scan trimmed pairs: SCRD12, SCRD28 \& D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe \& left lower lobe) and 5 Regions (Upper, Lower, Central, Distal \& Total). For Untrimmed data and SCRD12 \& SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analyzed (represented by n=X1, X2 in the category title). This table presents the D12D28 scan trim pair data only.
Outcome measures
| Measure |
All NEMI
n=22 Participants
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
All NEMI
n=22 Participants
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
Placebo Via ELLIPTA
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
NEMI 700 mcg Via ELLIPTA
Participants were administered with NEMI 700 mcg once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
|---|---|---|---|---|
|
Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Lobes at Day 28
FRC,Scan Trimmed,Right Upper,Day 28,n=16,17
|
0.998 Milliliters per Liter
Interval 0.917 to 1.086
|
0.988 Milliliters per Liter
Interval 0.909 to 1.074
|
—
|
—
|
|
Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Lobes at Day 28
FRC,Scan Trimmed,Left Upper,Day 28,n=16,18
|
0.987 Milliliters per Liter
Interval 0.905 to 1.077
|
1.014 Milliliters per Liter
Interval 0.904 to 1.137
|
—
|
—
|
|
Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Lobes at Day 28
FRC,Scan Trimmed,Right Middle,Day 28,n=16,17
|
1.003 Milliliters per Liter
Interval 0.876 to 1.149
|
0.930 Milliliters per Liter
Interval 0.828 to 1.043
|
—
|
—
|
|
Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Lobes at Day 28
FRC,Scan Trimmed,Right Lower,Day 28,n=16,18
|
0.938 Milliliters per Liter
Interval 0.845 to 1.041
|
1.020 Milliliters per Liter
Interval 0.884 to 1.176
|
—
|
—
|
|
Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Lobes at Day 28
FRC,Scan Trimmed,Left Lower,Day 28,n=16,18
|
0.947 Milliliters per Liter
Interval 0.849 to 1.057
|
1.042 Milliliters per Liter
Interval 0.905 to 1.2
|
—
|
—
|
|
Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Lobes at Day 28
TLC, Scan Trimmed,Right Upper,Day 28,n=17,18
|
0.963 Milliliters per Liter
Interval 0.875 to 1.061
|
0.965 Milliliters per Liter
Interval 0.928 to 1.004
|
—
|
—
|
|
Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Lobes at Day 28
TLC, Scan Trimmed,Left Upper,Day 28,n=17,19
|
0.984 Milliliters per Liter
Interval 0.896 to 1.079
|
0.999 Milliliters per Liter
Interval 0.94 to 1.061
|
—
|
—
|
|
Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Lobes at Day 28
TLC, Scan Trimmed,Right Middle,Day 28,n=17,18
|
0.807 Milliliters per Liter
Interval 0.601 to 1.084
|
0.897 Milliliters per Liter
Interval 0.829 to 0.971
|
—
|
—
|
|
Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Lobes at Day 28
TLC, Scan Trimmed,Right Lower,Day 28,n=17,19
|
0.945 Milliliters per Liter
Interval 0.848 to 1.052
|
0.943 Milliliters per Liter
Interval 0.892 to 0.997
|
—
|
—
|
|
Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Lobes at Day 28
TLC, Scan Trimmed,Left Lower,Day 28,n=17,19
|
0.950 Milliliters per Liter
Interval 0.863 to 1.046
|
0.963 Milliliters per Liter
Interval 0.868 to 1.069
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Screening), Days 12 and 28Population: All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
siVaw was measured at FRC and TLC. Data was collected at longitudinal time points (Untrimmed data): Baseline (Screening), Day 12 \& Day 28 and at each time point for scan trimmed pairs: SCRD12, SCRD28 \& D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe \& left lower lobe) and 5 Regions (Upper, Lower, Central, Distal \& Total). For Untrimmed data and SCRD12 \& SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analyzed (n=X1, X2 in the category title).This table presents the untrimmed data (in rows with categories containing untrimmed), SCRD12 scan trim pair data (in rows with categories containing Scan Trimmed and Day 12) and SCRD28 scan trim pair data (in rows with categories containing Scan Trimmed and Day 28) only.
Outcome measures
| Measure |
All NEMI
n=22 Participants
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
All NEMI
n=22 Participants
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
Placebo Via ELLIPTA
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
NEMI 700 mcg Via ELLIPTA
Participants were administered with NEMI 700 mcg once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
|---|---|---|---|---|
|
Change From Baseline in siVaw at FRC and TLC for Individual Regions
FRC,Scan Trimmed,Lower,Day 12,n=17,17
|
1.003 Milliliters per Liter
Interval 0.881 to 1.143
|
1.039 Milliliters per Liter
Interval 0.901 to 1.199
|
—
|
—
|
|
Change From Baseline in siVaw at FRC and TLC for Individual Regions
FRC,Scan Trimmed,Central,Day 28,n=16,19
|
1.048 Milliliters per Liter
Interval 0.928 to 1.183
|
1.045 Milliliters per Liter
Interval 0.996 to 1.096
|
—
|
—
|
|
Change From Baseline in siVaw at FRC and TLC for Individual Regions
FRC,Untrimmed,Central, Day 28,n=16,19
|
1.054 Milliliters per Liter
Interval 0.935 to 1.188
|
1.048 Milliliters per Liter
Interval 0.994 to 1.1
|
—
|
—
|
|
Change From Baseline in siVaw at FRC and TLC for Individual Regions
FRC,Untrimmed,Distal, Day 28,n=16,19
|
0.981 Milliliters per Liter
Interval 0.752 to 1.279
|
1.071 Milliliters per Liter
Interval 0.892 to 1.285
|
—
|
—
|
|
Change From Baseline in siVaw at FRC and TLC for Individual Regions
TLC,Untrimmed,Central, Day 12,n=20,18
|
1.012 Milliliters per Liter
Interval 0.985 to 1.04
|
1.027 Milliliters per Liter
Interval 0.998 to 1.057
|
—
|
—
|
|
Change From Baseline in siVaw at FRC and TLC for Individual Regions
TLC,Untrimmed,Central, Day 28,n=18,20
|
1.010 Milliliters per Liter
Interval 0.974 to 1.047
|
1.002 Milliliters per Liter
Interval 0.979 to 1.026
|
—
|
—
|
|
Change From Baseline in siVaw at FRC and TLC for Individual Regions
FRC,Scan Trimmed,Upper,Day 12,n=18,17
|
0.996 Milliliters per Liter
Interval 0.84 to 1.18
|
1.024 Milliliters per Liter
Interval 0.888 to 1.181
|
—
|
—
|
|
Change From Baseline in siVaw at FRC and TLC for Individual Regions
FRC,Scan Trimmed,Upper,Day 28,n=16,19
|
1.011 Milliliters per Liter
Interval 0.814 to 1.257
|
1.029 Milliliters per Liter
Interval 0.934 to 1.133
|
—
|
—
|
|
Change From Baseline in siVaw at FRC and TLC for Individual Regions
FRC,Scan Trimmed,Lower,Day 28,n=16,19
|
0.991 Milliliters per Liter
Interval 0.873 to 1.125
|
1.041 Milliliters per Liter
Interval 0.942 to 1.15
|
—
|
—
|
|
Change From Baseline in siVaw at FRC and TLC for Individual Regions
FRC,Scan Trimmed,Central,Day 12,n=18,17
|
1.027 Milliliters per Liter
Interval 0.917 to 1.151
|
1.052 Milliliters per Liter
Interval 0.998 to 1.108
|
—
|
—
|
|
Change From Baseline in siVaw at FRC and TLC for Individual Regions
FRC,Scan Trimmed,Distal,Day 12,n=18,17
|
0.970 Milliliters per Liter
Interval 0.859 to 1.096
|
1.029 Milliliters per Liter
Interval 0.891 to 1.187
|
—
|
—
|
|
Change From Baseline in siVaw at FRC and TLC for Individual Regions
FRC,Scan Trimmed,Distal,Day 28,n=16,19
|
0.980 Milliliters per Liter
Interval 0.844 to 1.138
|
1.037 Milliliters per Liter
Interval 0.945 to 1.138
|
—
|
—
|
|
Change From Baseline in siVaw at FRC and TLC for Individual Regions
FRC,Scan Trimmed,Total,Day 12,n=18,17
|
1.023 Milliliters per Liter
Interval 0.914 to 1.144
|
1.046 Milliliters per Liter
Interval 0.989 to 1.106
|
—
|
—
|
|
Change From Baseline in siVaw at FRC and TLC for Individual Regions
FRC,Scan Trimmed,Total,Day 28,n=16,19
|
1.041 Milliliters per Liter
Interval 0.923 to 1.175
|
1.042 Milliliters per Liter
Interval 0.994 to 1.091
|
—
|
—
|
|
Change From Baseline in siVaw at FRC and TLC for Individual Regions
TLC, Scan Trimmed,Upper,Day 12,n=20,18
|
0.963 Milliliters per Liter
Interval 0.904 to 1.026
|
0.982 Milliliters per Liter
Interval 0.87 to 1.109
|
—
|
—
|
|
Change From Baseline in siVaw at FRC and TLC for Individual Regions
TLC, Scan Trimmed,Upper,Day 28,n=18,20
|
0.939 Milliliters per Liter
Interval 0.863 to 1.022
|
0.945 Milliliters per Liter
Interval 0.865 to 1.033
|
—
|
—
|
|
Change From Baseline in siVaw at FRC and TLC for Individual Regions
TLC, Scan Trimmed,Lower,Day 12,n=20,18
|
0.996 Milliliters per Liter
Interval 0.924 to 1.074
|
0.982 Milliliters per Liter
Interval 0.88 to 1.096
|
—
|
—
|
|
Change From Baseline in siVaw at FRC and TLC for Individual Regions
TLC, Scan Trimmed,Lower,Day 28,n=18,20
|
0.958 Milliliters per Liter
Interval 0.852 to 1.078
|
0.925 Milliliters per Liter
Interval 0.848 to 1.009
|
—
|
—
|
|
Change From Baseline in siVaw at FRC and TLC for Individual Regions
TLC, Scan Trimmed,Central,Day 12,n=20,18
|
1.011 Milliliters per Liter
Interval 0.981 to 1.042
|
1.029 Milliliters per Liter
Interval 1.0 to 1.058
|
—
|
—
|
|
Change From Baseline in siVaw at FRC and TLC for Individual Regions
TLC, Scan Trimmed,Central,Day 28,n=18,20
|
1.013 Milliliters per Liter
Interval 0.979 to 1.048
|
1.006 Milliliters per Liter
Interval 0.984 to 1.028
|
—
|
—
|
|
Change From Baseline in siVaw at FRC and TLC for Individual Regions
TLC, Scan Trimmed,Distal,Day 12,n=20,18
|
0.979 Milliliters per Liter
Interval 0.917 to 1.045
|
0.981 Milliliters per Liter
Interval 0.876 to 1.098
|
—
|
—
|
|
Change From Baseline in siVaw at FRC and TLC for Individual Regions
TLC, Scan Trimmed,Distal,Day 28,n=18,20
|
0.948 Milliliters per Liter
Interval 0.864 to 1.04
|
0.934 Milliliters per Liter
Interval 0.86 to 1.015
|
—
|
—
|
|
Change From Baseline in siVaw at FRC and TLC for Individual Regions
TLC, Scan Trimmed,Total,Day 12,n=20,18
|
1.004 Milliliters per Liter
Interval 0.971 to 1.037
|
1.020 Milliliters per Liter
Interval 0.982 to 1.06
|
—
|
—
|
|
Change From Baseline in siVaw at FRC and TLC for Individual Regions
TLC, Scan Trimmed,Total,Day 28,n=18,20
|
1.001 Milliliters per Liter
Interval 0.968 to 1.035
|
0.990 Milliliters per Liter
Interval 0.967 to 1.014
|
—
|
—
|
|
Change From Baseline in siVaw at FRC and TLC for Individual Regions
FRC,Untrimmed,Upper,Day 12,n= 18,17
|
0.967 Milliliters per Liter
Interval 0.722 to 1.296
|
1.050 Milliliters per Liter
Interval 0.842 to 1.309
|
—
|
—
|
|
Change From Baseline in siVaw at FRC and TLC for Individual Regions
FRC,Untrimmed,Upper, Day 28,n=16,19
|
1.027 Milliliters per Liter
Interval 0.699 to 1.507
|
1.066 Milliliters per Liter
Interval 0.888 to 1.279
|
—
|
—
|
|
Change From Baseline in siVaw at FRC and TLC for Individual Regions
FRC,Untrimmed,Lower, Day 12,n=17,17
|
1.055 Milliliters per Liter
Interval 0.786 to 1.415
|
1.026 Milliliters per Liter
Interval 0.781 to 1.346
|
—
|
—
|
|
Change From Baseline in siVaw at FRC and TLC for Individual Regions
FRC,Untrimmed, Lower, Day 28,n=16,19
|
0.991 Milliliters per Liter
Interval 0.779 to 1.261
|
1.077 Milliliters per Liter
Interval 0.886 to 1.308
|
—
|
—
|
|
Change From Baseline in siVaw at FRC and TLC for Individual Regions
FRC,Untrimmed,Central, Day 12,n=18,17
|
1.035 Milliliters per Liter
Interval 0.928 to 1.153
|
1.059 Milliliters per Liter
Interval 1.008 to 1.113
|
—
|
—
|
|
Change From Baseline in siVaw at FRC and TLC for Individual Regions
FRC,Untrimmed,Distal, Day 12,n=18,17
|
0.926 Milliliters per Liter
Interval 0.729 to 1.177
|
1.037 Milliliters per Liter
Interval 0.82 to 1.313
|
—
|
—
|
|
Change From Baseline in siVaw at FRC and TLC for Individual Regions
FRC,Untrimmed,Total, Day 12,n=18,17
|
1.025 Milliliters per Liter
Interval 0.913 to 1.151
|
1.050 Milliliters per Liter
Interval 0.983 to 1.122
|
—
|
—
|
|
Change From Baseline in siVaw at FRC and TLC for Individual Regions
FRC,Untrimmed,Total, Day 28,n=16,19
|
1.045 Milliliters per Liter
Interval 0.913 to 1.195
|
1.046 Milliliters per Liter
Interval 0.988 to 1.107
|
—
|
—
|
|
Change From Baseline in siVaw at FRC and TLC for Individual Regions
TLC,Untrimmed,Upper,Day 12,n= 20,18
|
0.961 Milliliters per Liter
Interval 0.853 to 1.082
|
0.959 Milliliters per Liter
Interval 0.807 to 1.139
|
—
|
—
|
|
Change From Baseline in siVaw at FRC and TLC for Individual Regions
TLC,Untrimmed,Upper, Day 28,n=18,20
|
0.906 Milliliters per Liter
Interval 0.818 to 1.003
|
0.923 Milliliters per Liter
Interval 0.815 to 1.045
|
—
|
—
|
|
Change From Baseline in siVaw at FRC and TLC for Individual Regions
TLC,Untrimmed,Lower, Day 12,n=20,18
|
1.035 Milliliters per Liter
Interval 0.907 to 1.182
|
0.938 Milliliters per Liter
Interval 0.804 to 1.095
|
—
|
—
|
|
Change From Baseline in siVaw at FRC and TLC for Individual Regions
TLC,Untrimmed, Lower, Day 28,n=18,20
|
0.933 Milliliters per Liter
Interval 0.766 to 1.138
|
0.916 Milliliters per Liter
Interval 0.82 to 1.022
|
—
|
—
|
|
Change From Baseline in siVaw at FRC and TLC for Individual Regions
TLC,Untrimmed,Distal, Day 12,n=20,18
|
0.996 Milliliters per Liter
Interval 0.882 to 1.124
|
0.946 Milliliters per Liter
Interval 0.807 to 1.11
|
—
|
—
|
|
Change From Baseline in siVaw at FRC and TLC for Individual Regions
TLC,Untrimmed,Distal, Day 28,n=18,20
|
0.922 Milliliters per Liter
Interval 0.803 to 1.057
|
0.918 Milliliters per Liter
Interval 0.824 to 1.022
|
—
|
—
|
|
Change From Baseline in siVaw at FRC and TLC for Individual Regions
TLC,Untrimmed,Total, Day 12,n=20,18
|
1.000 Milliliters per Liter
Interval 0.97 to 1.031
|
1.009 Milliliters per Liter
Interval 0.962 to 1.059
|
—
|
—
|
|
Change From Baseline in siVaw at FRC and TLC for Individual Regions
TLC,Untrimmed,Total, Day 28,n=18,20
|
0.993 Milliliters per Liter
Interval 0.95 to 1.038
|
0.982 Milliliters per Liter
Interval 0.957 to 1.008
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 12) and Day 28Population: All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
siVaw is a measure of the volume in an individual's airway corrected for their lobar volume derived from the high resolution computed tomography (HRCT). It was measured at FRC and TLC. Data was collected at longitudinal time points (Untrimmed data): Baseline (Screening), Day 12 \& Day 28 and at each time point for scan trimmed pairs: SCRD12, SCRD28 \& D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe \& left lower lobe) and 5 Regions (Upper, Lower, Central, Distal \& Total). For Untrimmed data and SCRD12 \& SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analyzed (represented by n=X1, X2 in the category title). This table presents the D12D28 scan trim pair data only.
Outcome measures
| Measure |
All NEMI
n=22 Participants
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
All NEMI
n=22 Participants
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
Placebo Via ELLIPTA
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
NEMI 700 mcg Via ELLIPTA
Participants were administered with NEMI 700 mcg once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
|---|---|---|---|---|
|
Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Regions at Day 28
FRC,Scan Trimmed,Upper,Day 28,n=16,18
|
0.996 Milliliters per Liter
Interval 0.917 to 1.082
|
0.986 Milliliters per Liter
Interval 0.907 to 1.072
|
—
|
—
|
|
Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Regions at Day 28
FRC,Scan Trimmed,Lower,Day 28,n=16,18
|
0.948 Milliliters per Liter
Interval 0.862 to 1.042
|
1.025 Milliliters per Liter
Interval 0.909 to 1.155
|
—
|
—
|
|
Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Regions at Day 28
FRC,Scan Trimmed,Central,Day 28,n=16,18
|
0.997 Milliliters per Liter
Interval 0.955 to 1.042
|
1.014 Milliliters per Liter
Interval 0.955 to 1.076
|
—
|
—
|
|
Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Regions at Day 28
FRC,Scan Trimmed,Distal,Day 28,n=16,18
|
0.977 Milliliters per Liter
Interval 0.898 to 1.063
|
0.996 Milliliters per Liter
Interval 0.914 to 1.085
|
—
|
—
|
|
Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Regions at Day 28
FRC,Scan Trimmed,Total,Day 28,n=16, 18
|
0.997 Milliliters per Liter
Interval 0.952 to 1.043
|
1.012 Milliliters per Liter
Interval 0.953 to 1.075
|
—
|
—
|
|
Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Regions at Day 28
TLC,Scan Trimmed,Upper,Day 28,n=17,19
|
0.973 Milliliters per Liter
Interval 0.884 to 1.07
|
0.970 Milliliters per Liter
Interval 0.93 to 1.012
|
—
|
—
|
|
Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Regions at Day 28
TLC,Scan Trimmed,Lower,Day 28,n=17, 19
|
0.954 Milliliters per Liter
Interval 0.865 to 1.051
|
0.952 Milliliters per Liter
Interval 0.893 to 1.014
|
—
|
—
|
|
Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Regions at Day 28
TLC,Scan Trimmed,Central,Day 28,n=17,19
|
1.009 Milliliters per Liter
Interval 0.979 to 1.04
|
0.977 Milliliters per Liter
Interval 0.943 to 1.012
|
—
|
—
|
|
Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Regions at Day 28
TLC,Scan Trimmed,Distal,Day 28,n=17,19
|
0.967 Milliliters per Liter
Interval 0.88 to 1.063
|
0.960 Milliliters per Liter
Interval 0.917 to 1.004
|
—
|
—
|
|
Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Regions at Day 28
TLC,Scan Trimmed,Total,Day 28,n=17,19
|
1.003 Milliliters per Liter
Interval 0.965 to 1.042
|
0.972 Milliliters per Liter
Interval 0.939 to 1.006
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Screening) and Days 12 and 28Population: All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
iVaw was measured at FRC and TLC. Data was collected at longitudinal time points (Untrimmed data): Screening, Day 12 \& Day 28 and at each time point for scan trimmed pairs: SCRD12, SCRD28 \& D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe \& left lower lobe) and 5 Regions (Upper, Lower, Central, Distal \& Total). For Untrimmed data and SCRD12 \& SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analyzed (n=X1, X2 in the category title). This table presents the untrimmed data (in rows with categories containing untrimmed), SCRD12 scan trim pair data (in rows with categories containing Scan Trimmed and Day 12) and SCRD28 scan trim pair data (in rows with categories containing Scan Trimmed and Day 28) only.
Outcome measures
| Measure |
All NEMI
n=22 Participants
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
All NEMI
n=22 Participants
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
Placebo Via ELLIPTA
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
NEMI 700 mcg Via ELLIPTA
Participants were administered with NEMI 700 mcg once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
|---|---|---|---|---|
|
Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes
FRC,Scan Trimmed,Right Lower,Day 28,n=16,19
|
1.042 Milliliters
Interval 0.879 to 1.235
|
1.025 Milliliters
Interval 0.889 to 1.181
|
—
|
—
|
|
Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes
TLC,Untrimmed,Right Upper,Day 12,n=20,18
|
0.960 Milliliters
Interval 0.839 to 1.098
|
0.984 Milliliters
Interval 0.822 to 1.178
|
—
|
—
|
|
Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes
TLC,Untrimmed,Right Upper, Day 28,n=18,20
|
0.874 Milliliters
Interval 0.754 to 1.012
|
0.923 Milliliters
Interval 0.797 to 1.069
|
—
|
—
|
|
Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes
TLC,Untrimmed,Right Lower, Day 28,n=18,20
|
0.963 Milliliters
Interval 0.795 to 1.166
|
0.843 Milliliters
Interval 0.725 to 0.981
|
—
|
—
|
|
Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes
TLC,Untrimmed,Left Lower, Day 12,n=20,18
|
0.996 Milliliters
Interval 0.888 to 1.117
|
0.967 Milliliters
Interval 0.797 to 1.172
|
—
|
—
|
|
Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes
FRC,Scan Trimmed,Right Upper,Day 12,n=18,17
|
1.007 Milliliters
Interval 0.847 to 1.197
|
1.044 Milliliters
Interval 0.879 to 1.24
|
—
|
—
|
|
Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes
FRC,Scan Trimmed,Right Upper,Day 28,n=16,19
|
1.016 Milliliters
Interval 0.826 to 1.249
|
1.037 Milliliters
Interval 0.931 to 1.155
|
—
|
—
|
|
Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes
FRC,Scan Trimmed,Left Upper,Day 12,n=18,17
|
0.965 Milliliters
Interval 0.783 to 1.19
|
0.987 Milliliters
Interval 0.83 to 1.173
|
—
|
—
|
|
Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes
FRC,Scan Trimmed,Left Upper,Day 28,n=16,19
|
0.998 Milliliters
Interval 0.767 to 1.299
|
1.062 Milliliters
Interval 0.919 to 1.227
|
—
|
—
|
|
Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes
FRC,Right Middle,Day 12,n=18,17
|
1.129 Milliliters
Interval 0.803 to 1.588
|
1.014 Milliliters
Interval 0.874 to 1.176
|
—
|
—
|
|
Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes
FRC,Scan Trimmed,Right Middle,Day 28,n=16,19
|
0.950 Milliliters
Interval 0.739 to 1.221
|
1.018 Milliliters
Interval 0.881 to 1.176
|
—
|
—
|
|
Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes
FRC,Right Lower,Day 12,n=17,17
|
1.046 Milliliters
Interval 0.884 to 1.237
|
1.005 Milliliters
Interval 0.824 to 1.225
|
—
|
—
|
|
Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes
FRC,Left Lower,Day 12,n=17,17
|
1.003 Milliliters
Interval 0.855 to 1.178
|
1.010 Milliliters
Interval 0.832 to 1.226
|
—
|
—
|
|
Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes
FRC,Scan Trimmed,Left Lower,Day 28,n=16,19
|
0.971 Milliliters
Interval 0.836 to 1.127
|
1.029 Milliliters
Interval 0.92 to 1.151
|
—
|
—
|
|
Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes
TLC,Scan Trimmed,Right Upper,Day 12,n=20,18
|
0.976 Milliliters
Interval 0.903 to 1.054
|
0.982 Milliliters
Interval 0.864 to 1.117
|
—
|
—
|
|
Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes
TLC,Scan Trimmed,Right Upper,Day 28,n=18,20
|
0.941 Milliliters
Interval 0.858 to 1.032
|
0.946 Milliliters
Interval 0.849 to 1.054
|
—
|
—
|
|
Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes
TLC,Scan Trimmed,Left Upper,Day 12,n=20,18
|
0.957 Milliliters
Interval 0.897 to 1.02
|
0.958 Milliliters
Interval 0.84 to 1.093
|
—
|
—
|
|
Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes
TLC,Scan Trimmed,Left Upper,Day 28,n=18,20
|
0.928 Milliliters
Interval 0.849 to 1.015
|
0.938 Milliliters
Interval 0.857 to 1.025
|
—
|
—
|
|
Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes
TLC,Scan Trimmed,Right Middle,Day 12,n=19,18
|
0.882 Milliliters
Interval 0.81 to 0.961
|
0.988 Milliliters
Interval 0.881 to 1.108
|
—
|
—
|
|
Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes
TLC,Scan Trimmed,Right Middle,Day 28,n=18,20
|
0.873 Milliliters
Interval 0.742 to 1.027
|
0.895 Milliliters
Interval 0.811 to 0.987
|
—
|
—
|
|
Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes
TLC,Scan Trimmed,Right Lower,Day 12,n=20,18
|
1.083 Milliliters
Interval 0.966 to 1.214
|
0.937 Milliliters
Interval 0.828 to 1.061
|
—
|
—
|
|
Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes
TLC,Scan Trimmed,Right Lower,Day 28,n=18,20
|
0.967 Milliliters
Interval 0.86 to 1.088
|
0.877 Milliliters
Interval 0.782 to 0.983
|
—
|
—
|
|
Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes
TLC,Scan Trimmed,Left Lower,Day 12,n=20,18
|
0.981 Milliliters
Interval 0.922 to 1.044
|
0.981 Milliliters
Interval 0.85 to 1.131
|
—
|
—
|
|
Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes
TLC,Scan Trimmed,Left Lower,Day 28,n=18,20
|
0.939 Milliliters
Interval 0.832 to 1.06
|
0.923 Milliliters
Interval 0.843 to 1.01
|
—
|
—
|
|
Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes
FRC,Untrimmed,Right Upper,Day 12,n= 18,17
|
0.886 Milliliters
Interval 0.652 to 1.203
|
1.095 Milliliters
Interval 0.858 to 1.396
|
—
|
—
|
|
Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes
FRC,Untrimmed,Right Upper, Day 28,n=16,19
|
0.990 Milliliters
Interval 0.703 to 1.393
|
1.083 Milliliters
Interval 0.923 to 1.272
|
—
|
—
|
|
Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes
FRC,Untrimmed,Left Upper, Day 12,n=18,17
|
0.996 Milliliters
Interval 0.668 to 1.485
|
0.950 Milliliters
Interval 0.696 to 1.297
|
—
|
—
|
|
Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes
FRC,Untrimmed,Left Upper, Day 28,n=16,19
|
1.071 Milliliters
Interval 0.656 to 1.749
|
1.074 Milliliters
Interval 0.798 to 1.444
|
—
|
—
|
|
Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes
FRC,Untrimmed,Right Middle, Day 12,n=18,17
|
1.167 Milliliters
Interval 0.633 to 2.149
|
1.157 Milliliters
Interval 0.84 to 1.595
|
—
|
—
|
|
Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes
FRC,Untrimmed,Right Middle, Day 28,n=16,19
|
0.991 Milliliters
Interval 0.629 to 1.562
|
1.155 Milliliters
Interval 0.819 to 1.631
|
—
|
—
|
|
Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes
FRC,Untrimmed,Right Lower, Day 12,n=17,17
|
1.262 Milliliters
Interval 0.791 to 2.015
|
0.990 Milliliters
Interval 0.703 to 1.392
|
—
|
—
|
|
Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes
TLC,Untrimmed,Left Lower, Day 28,n=18,20
|
0.881 Milliliters
Interval 0.675 to 1.149
|
0.940 Milliliters
Interval 0.828 to 1.066
|
—
|
—
|
|
Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes
FRC,Untrimmed,Right Lower, Day 28,n=16,19
|
1.253 Milliliters
Interval 0.832 to 1.885
|
1.014 Milliliters
Interval 0.784 to 1.311
|
—
|
—
|
|
Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes
FRC,Untrimmed,Left Lower, Day 12,n=17,17
|
0.959 Milliliters
Interval 0.714 to 1.287
|
0.981 Milliliters
Interval 0.655 to 1.469
|
—
|
—
|
|
Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes
FRC,Untrimmed,Left Lower, Day 28,n=16,19
|
0.813 Milliliters
Interval 0.571 to 1.157
|
1.107 Milliliters
Interval 0.882 to 1.389
|
—
|
—
|
|
Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes
TLC,Untrimmed,Left Upper, Day 12,n=20,18
|
0.958 Milliliters
Interval 0.853 to 1.075
|
0.932 Milliliters
Interval 0.779 to 1.116
|
—
|
—
|
|
Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes
TLC,Untrimmed,Left Upper, Day 28,n=18,20
|
0.942 Milliliters
Interval 0.85 to 1.043
|
0.914 Milliliters
Interval 0.8 to 1.045
|
—
|
—
|
|
Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes
TLC,Untrimmed,Right Middle, Day 12,n=19,18
|
0.872 Milliliters
Interval 0.724 to 1.05
|
0.952 Milliliters
Interval 0.806 to 1.124
|
—
|
—
|
|
Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes
TLC,Untrimmed,Right Middle, Day 28,n=18,20
|
0.622 Milliliters
Interval 0.367 to 1.053
|
0.886 Milliliters
Interval 0.78 to 1.007
|
—
|
—
|
|
Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes
TLC,Untrimmed,Right Lower, Day 12,n=20,18
|
1.162 Milliliters
Interval 0.914 to 1.476
|
0.871 Milliliters
Interval 0.721 to 1.053
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 12) and Day 28Population: All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
iVaw is a measure of the volume in an individual's airway derived from the HRCT. It was measured at FRC and TLC. Data was collected at longitudinal time points (Untrimmed data): Screening, Day 12 \& Day 28 and at each time point for scan trimmed pairs: SCRD12, SCRD28 \& D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe \& left lower lobe) and 5 Regions (Upper, Lower, Central, Distal \& Total). For Untrimmed data and SCRD12 \& SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analyzed (represented by n=X1, X2 in the category title). This table presents the D12D28 scan trim pair data only.
Outcome measures
| Measure |
All NEMI
n=22 Participants
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
All NEMI
n=22 Participants
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
Placebo Via ELLIPTA
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
NEMI 700 mcg Via ELLIPTA
Participants were administered with NEMI 700 mcg once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
|---|---|---|---|---|
|
Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Lobes at Day 28
FRC,Scan Trimmed,Right Upper,Day 28,n=16,18
|
0.995 Milliliters
Interval 0.918 to 1.078
|
0.977 Milliliters
Interval 0.88 to 1.084
|
—
|
—
|
|
Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Lobes at Day 28
FRC,Scan Trimmed,Left Upper,Day 28,n=16,18
|
0.973 Milliliters
Interval 0.891 to 1.063
|
1.016 Milliliters
Interval 0.898 to 1.151
|
—
|
—
|
|
Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Lobes at Day 28
FRC,Scan Trimmed,Right Middle,Day 28,n=16,18
|
0.958 Milliliters
Interval 0.842 to 1.09
|
0.943 Milliliters
Interval 0.838 to 1.061
|
—
|
—
|
|
Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Lobes at Day 28
FRC,Scan Trimmed,Right Lower,Day 28,n=16,18
|
0.918 Milliliters
Interval 0.821 to 1.025
|
1.008 Milliliters
Interval 0.855 to 1.188
|
—
|
—
|
|
Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Lobes at Day 28
FRC,Scan Trimmed,Left Lower,Day 28,n=16,18
|
0.943 Milliliters
Interval 0.852 to 1.045
|
1.024 Milliliters
Interval 0.877 to 1.196
|
—
|
—
|
|
Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Lobes at Day 28
TLC,Scan Trimmed,Right Upper,Day 28,n=17,19
|
0.963 Milliliters
Interval 0.875 to 1.06
|
0.966 Milliliters
Interval 0.936 to 0.997
|
—
|
—
|
|
Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Lobes at Day 28
TLC,Scan Trimmed,Left Upper,Day 28,n=17,19
|
0.976 Milliliters
Interval 0.885 to 1.076
|
0.996 Milliliters
Interval 0.942 to 1.052
|
—
|
—
|
|
Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Lobes at Day 28
TLC,Right Middle,Day 28,n=17,19
|
0.784 Milliliters
Interval 0.571 to 1.077
|
0.904 Milliliters
Interval 0.841 to 0.971
|
—
|
—
|
|
Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Lobes at Day 28
TLC,Scan Trimmed,Right Lower,Day 28,n=17,19
|
0.926 Milliliters
Interval 0.826 to 1.038
|
0.935 Milliliters
Interval 0.876 to 0.997
|
—
|
—
|
|
Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Lobes at Day 28
TLC,Scan Trimmed,Left Lower,Day 28,n=17,19
|
0.928 Milliliters
Interval 0.833 to 1.035
|
0.951 Milliliters
Interval 0.855 to 1.057
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Screening) and Days 12 and 28Population: All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
iVaw was measured at FRC and TLC. Data was collected at longitudinal time points (Untrimmed data): Screening, Day 12 \& Day 28 and at each time point for scan trimmed pairs: SCRD12, SCRD28 \& D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe \& left lower lobe) and 5 Regions (Upper, Lower, Central, Distal \& Total). For Untrimmed data and SCRD12 \& SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analyzed (n=X1, X2 in the category title). This table presents the untrimmed data (in rows with categories containing untrimmed), SCRD12 scan trim pair data (in rows with categories containing Scan Trimmed and Day 12) and SCRD28 scan trim pair data (in rows with categories containing Scan Trimmed and Day 28) only.
Outcome measures
| Measure |
All NEMI
n=22 Participants
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
All NEMI
n=22 Participants
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
Placebo Via ELLIPTA
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
NEMI 700 mcg Via ELLIPTA
Participants were administered with NEMI 700 mcg once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
|---|---|---|---|---|
|
Change From Baseline in iVaw at FRC and TLC for Individual Regions
FRC,Scan Trimmed,Total,Day 28,n=16,19
|
1.034 Milliliters
Interval 0.927 to 1.153
|
1.037 Milliliters
Interval 0.97 to 1.108
|
—
|
—
|
|
Change From Baseline in iVaw at FRC and TLC for Individual Regions
FRC,Scan Trimmed,Upper,Day 12,n=18,17
|
0.987 Milliliters
Interval 0.827 to 1.178
|
1.021 Milliliters
Interval 0.869 to 1.2
|
—
|
—
|
|
Change From Baseline in iVaw at FRC and TLC for Individual Regions
FRC,Scan Trimmed,Upper,Day 28,n=16,19
|
0.999 Milliliters
Interval 0.8 to 1.246
|
1.039 Milliliters
Interval 0.927 to 1.166
|
—
|
—
|
|
Change From Baseline in iVaw at FRC and TLC for Individual Regions
FRC,Scan Trimmed,Lower,Day 12,n=17,17
|
1.009 Milliliters
Interval 0.864 to 1.178
|
1.017 Milliliters
Interval 0.863 to 1.199
|
—
|
—
|
|
Change From Baseline in iVaw at FRC and TLC for Individual Regions
FRC,Scan Trimmed,Lower,Day 28,n=16,19
|
0.993 Milliliters
Interval 0.862 to 1.142
|
1.018 Milliliters
Interval 0.899 to 1.152
|
—
|
—
|
|
Change From Baseline in iVaw at FRC and TLC for Individual Regions
FRC,Scan Trimmed,Central,Day 12,n=18,17
|
1.025 Milliliters
Interval 0.925 to 1.136
|
1.040 Milliliters
Interval 0.985 to 1.097
|
—
|
—
|
|
Change From Baseline in iVaw at FRC and TLC for Individual Regions
FRC,Scan Trimmed,Central,Day 28,n=16,19
|
1.040 Milliliters
Interval 0.936 to 1.155
|
1.040 Milliliters
Interval 0.974 to 1.11
|
—
|
—
|
|
Change From Baseline in iVaw at FRC and TLC for Individual Regions
FRC,Scan Trimmed,Distal,Day 12,n=18,17
|
0.969 Milliliters
Interval 0.847 to 1.107
|
1.017 Milliliters
Interval 0.866 to 1.194
|
—
|
—
|
|
Change From Baseline in iVaw at FRC and TLC for Individual Regions
FRC,Scan Trimmed,Distal,Day 28,n=16,19
|
0.973 Milliliters
Interval 0.834 to 1.135
|
1.032 Milliliters
Interval 0.921 to 1.157
|
—
|
—
|
|
Change From Baseline in iVaw at FRC and TLC for Individual Regions
FRC,Scan Trimmed,Total,Day 12,n=18,17
|
1.021 Milliliters
Interval 0.92 to 1.132
|
1.034 Milliliters
Interval 0.97 to 1.101
|
—
|
—
|
|
Change From Baseline in iVaw at FRC and TLC for Individual Regions
TLC,Scan Trimmed,Upper,Day 12,n=20,18
|
0.959 Milliliters
Interval 0.899 to 1.023
|
0.973 Milliliters
Interval 0.86 to 1.101
|
—
|
—
|
|
Change From Baseline in iVaw at FRC and TLC for Individual Regions
TLC,Scan Trimmed,Upper,Day 28,n=18,20
|
0.930 Milliliters
Interval 0.851 to 1.015
|
0.935 Milliliters
Interval 0.853 to 1.024
|
—
|
—
|
|
Change From Baseline in iVaw at FRC and TLC for Individual Regions
TLC,Scan Trimmed,Lower,Day 12,n=20,18
|
1.017 Milliliters
Interval 0.945 to 1.094
|
0.960 Milliliters
Interval 0.858 to 1.074
|
—
|
—
|
|
Change From Baseline in iVaw at FRC and TLC for Individual Regions
TLC,Scan Trimmed,Lower,Day 28,n=18,20
|
0.958 Milliliters
Interval 0.846 to 1.084
|
0.902 Milliliters
Interval 0.823 to 0.989
|
—
|
—
|
|
Change From Baseline in iVaw at FRC and TLC for Individual Regions
TLC,Scan Trimmed,Central,Day 12,n=20,18
|
1.019 Milliliters
Interval 0.998 to 1.04
|
1.013 Milliliters
Interval 0.988 to 1.04
|
—
|
—
|
|
Change From Baseline in iVaw at FRC and TLC for Individual Regions
TLC,Scan Trimmed,Central,Day 28,n=18,20
|
1.006 Milliliters
Interval 0.984 to 1.028
|
0.989 Milliliters
Interval 0.965 to 1.013
|
—
|
—
|
|
Change From Baseline in iVaw at FRC and TLC for Individual Regions
TLC,Scan Trimmed,Distal,Day 12,n=20,18
|
0.986 Milliliters
Interval 0.924 to 1.053
|
0.966 Milliliters
Interval 0.862 to 1.083
|
—
|
—
|
|
Change From Baseline in iVaw at FRC and TLC for Individual Regions
TLC,Scan Trimmed,Distal,Day 28,n=18,20
|
0.941 Milliliters
Interval 0.854 to 1.038
|
0.918 Milliliters
Interval 0.842 to 1.002
|
—
|
—
|
|
Change From Baseline in iVaw at FRC and TLC for Individual Regions
TLC,Scan Trimmed,Total,Day 12,n=20,18
|
1.011 Milliliters
Interval 0.985 to 1.038
|
1.005 Milliliters
Interval 0.968 to 1.043
|
—
|
—
|
|
Change From Baseline in iVaw at FRC and TLC for Individual Regions
TLC,Scan Trimmed,Total,Day 28,n=18,20
|
0.994 Milliliters
Interval 0.967 to 1.022
|
0.973 Milliliters
Interval 0.947 to 1.0
|
—
|
—
|
|
Change From Baseline in iVaw at FRC and TLC for Individual Regions
FRC,Untrimmed,Upper,Day 12,n= 18,17
|
0.959 Milliliters
Interval 0.704 to 1.305
|
1.047 Milliliters
Interval 0.815 to 1.345
|
—
|
—
|
|
Change From Baseline in iVaw at FRC and TLC for Individual Regions
FRC,Untrimmed,Upper, Day 28,n=16,19
|
1.014 Milliliters
Interval 0.685 to 1.499
|
1.076 Milliliters
Interval 0.876 to 1.323
|
—
|
—
|
|
Change From Baseline in iVaw at FRC and TLC for Individual Regions
FRC,Untrimmed,Lower, Day 12,n=17,17
|
1.060 Milliliters
Interval 0.761 to 1.478
|
1.004 Milliliters
Interval 0.741 to 1.359
|
—
|
—
|
|
Change From Baseline in iVaw at FRC and TLC for Individual Regions
FRC,Untrimmed, Lower, Day 28,n=16,19
|
0.993 Milliliters
Interval 0.75 to 1.315
|
1.052 Milliliters
Interval 0.84 to 1.319
|
—
|
—
|
|
Change From Baseline in iVaw at FRC and TLC for Individual Regions
FRC,Untrimmed,Central, Day 12,n=18,17
|
1.033 Milliliters
Interval 0.92 to 1.16
|
1.047 Milliliters
Interval 0.967 to 1.134
|
—
|
—
|
|
Change From Baseline in iVaw at FRC and TLC for Individual Regions
FRC,Untrimmed,Central, Day 28,n=16,19
|
1.046 Milliliters
Interval 0.926 to 1.182
|
1.043 Milliliters
Interval 0.961 to 1.133
|
—
|
—
|
|
Change From Baseline in iVaw at FRC and TLC for Individual Regions
FRC,Untrimmed,Distal, Day 12,n=18,17
|
0.924 Milliliters
Interval 0.709 to 1.205
|
1.025 Milliliters
Interval 0.788 to 1.333
|
—
|
—
|
|
Change From Baseline in iVaw at FRC and TLC for Individual Regions
FRC,Untrimmed,Distal, Day 28,n=16,19
|
0.974 Milliliters
Interval 0.735 to 1.29
|
1.066 Milliliters
Interval 0.865 to 1.313
|
—
|
—
|
|
Change From Baseline in iVaw at FRC and TLC for Individual Regions
FRC,Untrimmed,Total, Day 12,n=18,17
|
1.023 Milliliters
Interval 0.9 to 1.163
|
1.038 Milliliters
Interval 0.941 to 1.145
|
—
|
—
|
|
Change From Baseline in iVaw at FRC and TLC for Individual Regions
FRC,Untrimmed,Total, Day 28,n=16,19
|
1.037 Milliliters
Interval 0.898 to 1.198
|
1.041 Milliliters
Interval 0.953 to 1.137
|
—
|
—
|
|
Change From Baseline in iVaw at FRC and TLC for Individual Regions
TLC,Untrimmed,Upper,Day 12,n= 20,18
|
0.957 Milliliters
Interval 0.841 to 1.089
|
0.950 Milliliters
Interval 0.8 to 1.129
|
—
|
—
|
|
Change From Baseline in iVaw at FRC and TLC for Individual Regions
TLC,Untrimmed,Upper, Day 28,n=18,20
|
0.897 Milliliters
Interval 0.805 to 0.998
|
0.912 Milliliters
Interval 0.804 to 1.035
|
—
|
—
|
|
Change From Baseline in iVaw at FRC and TLC for Individual Regions
TLC,Untrimmed,Lower, Day 12,n=20,18
|
1.057 Milliliters
Interval 0.915 to 1.22
|
0.917 Milliliters
Interval 0.783 to 1.074
|
—
|
—
|
|
Change From Baseline in iVaw at FRC and TLC for Individual Regions
TLC,Untrimmed, Lower, Day 28,n=18,20
|
0.933 Milliliters
Interval 0.759 to 1.147
|
0.893 Milliliters
Interval 0.795 to 1.002
|
—
|
—
|
|
Change From Baseline in iVaw at FRC and TLC for Individual Regions
TLC,Untrimmed,Central, Day 12,n=20,18
|
1.020 Milliliters
Interval 0.997 to 1.043
|
1.012 Milliliters
Interval 0.984 to 1.041
|
—
|
—
|
|
Change From Baseline in iVaw at FRC and TLC for Individual Regions
TLC,Untrimmed,Central, Day 28,n=18,20
|
1.003 Milliliters
Interval 0.976 to 1.032
|
0.985 Milliliters
Interval 0.959 to 1.012
|
—
|
—
|
|
Change From Baseline in iVaw at FRC and TLC for Individual Regions
TLC,Untrimmed,Distal, Day 12,n=20,18
|
1.003 Milliliters
Interval 0.881 to 1.143
|
0.932 Milliliters
Interval 0.795 to 1.093
|
—
|
—
|
|
Change From Baseline in iVaw at FRC and TLC for Individual Regions
TLC,Untrimmed,Distal, Day 28,n=18,20
|
0.916 Milliliters
Interval 0.793 to 1.056
|
0.902 Milliliters
Interval 0.808 to 1.008
|
—
|
—
|
|
Change From Baseline in iVaw at FRC and TLC for Individual Regions
TLC,Untrimmed,Total, Day 12,n=20,18
|
1.008 Milliliters
Interval 0.976 to 1.04
|
0.994 Milliliters
Interval 0.949 to 1.042
|
—
|
—
|
|
Change From Baseline in iVaw at FRC and TLC for Individual Regions
TLC,Untrimmed,Total, Day 28,n=18,20
|
0.986 Milliliters
Interval 0.945 to 1.03
|
0.965 Milliliters
Interval 0.936 to 0.995
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 12) and Day 28Population: All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
iVaw is a measure of the volume in an individual's airway derived from the HRCT. It was measured at FRC and TLC. Data was collected at longitudinal time points (Untrimmed data): Screening, Day 12 \& Day 28 and at each time point for scan trimmed pairs: SCRD12, SCRD28 \& D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe \& left lower lobe) and 5 Regions (Upper, Lower, Central, Distal \& Total). For Untrimmed data and SCRD12 \& SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analyzed (represented by n=X1, X2 in the category title). This table presents the D12D28 scan trim pair data only.
Outcome measures
| Measure |
All NEMI
n=22 Participants
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
All NEMI
n=22 Participants
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
Placebo Via ELLIPTA
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
NEMI 700 mcg Via ELLIPTA
Participants were administered with NEMI 700 mcg once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
|---|---|---|---|---|
|
Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Regions at Day 28
FRC,Scan Trimmed,Upper,Day 28,n=16,18
|
0.988 Milliliters
Interval 0.912 to 1.07
|
0.985 Milliliters
Interval 0.891 to 1.089
|
—
|
—
|
|
Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Regions at Day 28
FRC,Scan Trimmed,Lower,Day 28,n=16,18
|
0.934 Milliliters
Interval 0.847 to 1.03
|
1.010 Milliliters
Interval 0.876 to 1.165
|
—
|
—
|
|
Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Regions at Day 28
FRC,Scan Trimmed,Central,Day 28,n=16,18
|
0.985 Milliliters
Interval 0.953 to 1.019
|
1.008 Milliliters
Interval 0.942 to 1.078
|
—
|
—
|
|
Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Regions at Day 28
FRC,Scan Trimmed,Distal,Day 28,n=16,18
|
0.966 Milliliters
Interval 0.891 to 1.047
|
0.990 Milliliters
Interval 0.89 to 1.102
|
—
|
—
|
|
Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Regions at Day 28
FRC,Scan Trimmed,Total,Day 28,n=16,18
|
0.985 Milliliters
Interval 0.949 to 1.022
|
1.006 Milliliters
Interval 0.938 to 1.08
|
—
|
—
|
|
Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Regions at Day 28
TLC,Scan Trimmed,Upper,Day 28,n=17,19
|
0.968 Milliliters
Interval 0.877 to 1.067
|
0.968 Milliliters
Interval 0.932 to 1.005
|
—
|
—
|
|
Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Regions at Day 28
TLC,Scan Trimmed,Lower,Day 28,n=17,19
|
0.933 Milliliters
Interval 0.84 to 1.037
|
0.942 Milliliters
Interval 0.879 to 1.01
|
—
|
—
|
|
Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Regions at Day 28
TLC,Scan Trimmed,Central,Day 28,n=17,19
|
0.996 Milliliters
Interval 0.968 to 1.024
|
0.972 Milliliters
Interval 0.94 to 1.004
|
—
|
—
|
|
Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Regions at Day 28
TLC,Scan Trimmed,Distal,Day 28,n=17,19
|
0.954 Milliliters
Interval 0.865 to 1.052
|
0.954 Milliliters
Interval 0.912 to 0.998
|
—
|
—
|
|
Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Regions at Day 28
TLC,Scan Trimmed,Total,Day 28,n=17,19
|
0.989 Milliliters
Interval 0.952 to 1.028
|
0.966 Milliliters
Interval 0.936 to 0.998
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Screening) and Days 12 and 28Population: All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
iRaw is a measure of the resistance in an individual's airway derived from HRCT. It was measured at FRC and TLC. Data was collected at each time point for scan trimmed pairs: SCRD12, SCRD28 \& D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe \& left lower lobe) and 5 Regions (Upper, Lower, Central, Distal \& Total). For SCRD12 \& SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analyzed (represented by n=X1, X2 in the category title). • This table presents the SCRD12 scan trim pair data (in rows with categories containing Scan Trimmed and Day 12) and SCRD28 scan trim pair data (in rows with categories containing Scan Trimmed and Day 28) only.
Outcome measures
| Measure |
All NEMI
n=22 Participants
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
All NEMI
n=22 Participants
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
Placebo Via ELLIPTA
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
NEMI 700 mcg Via ELLIPTA
Participants were administered with NEMI 700 mcg once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
|---|---|---|---|---|
|
Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes
FRC,Scan Trimmed,Right Upper,Day 12,n=18,17
|
1.129 Kilopascal* seconds per liter (kPa*s/L)
Interval 0.641 to 1.991
|
0.876 Kilopascal* seconds per liter (kPa*s/L)
Interval 0.477 to 1.606
|
—
|
—
|
|
Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes
FRC,Scan Trimmed,Right Upper,Day 28,n=16,19
|
1.213 Kilopascal* seconds per liter (kPa*s/L)
Interval 0.569 to 2.586
|
0.884 Kilopascal* seconds per liter (kPa*s/L)
Interval 0.582 to 1.343
|
—
|
—
|
|
Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes
FRC,Scan Trimmed,Left Upper,Day 12,n=18,17
|
1.058 Kilopascal* seconds per liter (kPa*s/L)
Interval 0.631 to 1.774
|
0.951 Kilopascal* seconds per liter (kPa*s/L)
Interval 0.592 to 1.53
|
—
|
—
|
|
Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes
FRC,Scan Trimmed,Left Upper,Day 28,n=16,19
|
1.151 Kilopascal* seconds per liter (kPa*s/L)
Interval 0.582 to 2.273
|
0.681 Kilopascal* seconds per liter (kPa*s/L)
Interval 0.438 to 1.06
|
—
|
—
|
|
Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes
FRC,Scan Trimmed,Right Middle,Day 12,n=18,17
|
0.559 Kilopascal* seconds per liter (kPa*s/L)
Interval 0.198 to 1.576
|
0.970 Kilopascal* seconds per liter (kPa*s/L)
Interval 0.578 to 1.627
|
—
|
—
|
|
Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes
FRC,Scan Trimmed,Right Middle,Day 28,n=16,19
|
1.420 Kilopascal* seconds per liter (kPa*s/L)
Interval 0.573 to 3.518
|
1.275 Kilopascal* seconds per liter (kPa*s/L)
Interval 0.732 to 2.219
|
—
|
—
|
|
Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes
FRC,Scan Trimmed,Right Lower,Day 12,n=17,17
|
0.903 Kilopascal* seconds per liter (kPa*s/L)
Interval 0.352 to 2.314
|
1.149 Kilopascal* seconds per liter (kPa*s/L)
Interval 0.714 to 1.849
|
—
|
—
|
|
Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes
FRC,Scan Trimmed,Right Lower,Day 28,n=16,19
|
0.681 Kilopascal* seconds per liter (kPa*s/L)
Interval 0.251 to 1.85
|
0.935 Kilopascal* seconds per liter (kPa*s/L)
Interval 0.512 to 1.706
|
—
|
—
|
|
Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes
FRC,Scan Trimmed,Left Lower,Day 12,n=17,17
|
1.084 Kilopascal* seconds per liter (kPa*s/L)
Interval 0.642 to 1.832
|
0.902 Kilopascal* seconds per liter (kPa*s/L)
Interval 0.378 to 2.157
|
—
|
—
|
|
Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes
FRC,Scan Trimmed,Left Lower,Day 28,n=16,19
|
1.576 Kilopascal* seconds per liter (kPa*s/L)
Interval 0.656 to 3.785
|
0.904 Kilopascal* seconds per liter (kPa*s/L)
Interval 0.642 to 1.274
|
—
|
—
|
|
Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes
TLC,Scan Trimmed,Right Upper,Day 12,n=20,18
|
1.058 Kilopascal* seconds per liter (kPa*s/L)
Interval 0.82 to 1.366
|
1.057 Kilopascal* seconds per liter (kPa*s/L)
Interval 0.739 to 1.511
|
—
|
—
|
|
Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes
TLC,Scan Trimmed,Right Upper,Day 28,n=18,20
|
1.307 Kilopascal* seconds per liter (kPa*s/L)
Interval 0.994 to 1.718
|
1.292 Kilopascal* seconds per liter (kPa*s/L)
Interval 0.951 to 1.755
|
—
|
—
|
|
Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes
TLC,Scan Trimmed,Left Upper,Day 12,n=20,18
|
1.129 Kilopascal* seconds per liter (kPa*s/L)
Interval 0.938 to 1.36
|
1.075 Kilopascal* seconds per liter (kPa*s/L)
Interval 0.662 to 1.747
|
—
|
—
|
|
Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes
TLC,Scan Trimmed,Left Upper,Day 28,n=18,20
|
1.212 Kilopascal* seconds per liter (kPa*s/L)
Interval 0.957 to 1.534
|
1.160 Kilopascal* seconds per liter (kPa*s/L)
Interval 0.851 to 1.58
|
—
|
—
|
|
Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes
TLC,Scan Trimmed,Right Middle,Day 12,n=19,18
|
1.190 Kilopascal* seconds per liter (kPa*s/L)
Interval 0.823 to 1.72
|
1.148 Kilopascal* seconds per liter (kPa*s/L)
Interval 0.747 to 1.763
|
—
|
—
|
|
Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes
TLC,Scan Trimmed,Right Middle,Day 28,n=18,20
|
1.749 Kilopascal* seconds per liter (kPa*s/L)
Interval 0.981 to 3.117
|
1.583 Kilopascal* seconds per liter (kPa*s/L)
Interval 1.002 to 2.502
|
—
|
—
|
|
Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes
TLC,Scan Trimmed,Right Lower,Day 12,n=20,18
|
0.727 Kilopascal* seconds per liter (kPa*s/L)
Interval 0.484 to 1.092
|
1.325 Kilopascal* seconds per liter (kPa*s/L)
Interval 0.86 to 2.041
|
—
|
—
|
|
Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes
TLC,Scan Trimmed,Right Lower,Day 28,n=18,20
|
1.143 Kilopascal* seconds per liter (kPa*s/L)
Interval 0.797 to 1.639
|
1.463 Kilopascal* seconds per liter (kPa*s/L)
Interval 1.077 to 1.988
|
—
|
—
|
|
Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes
TLC,Scan Trimmed,Left Lower,Day 12,n=20,18
|
1.003 Kilopascal* seconds per liter (kPa*s/L)
Interval 0.798 to 1.26
|
1.144 Kilopascal* seconds per liter (kPa*s/L)
Interval 0.714 to 1.833
|
—
|
—
|
|
Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes
TLC,Scan Trimmed,Left Lower,Day 28,n=18,20
|
1.259 Kilopascal* seconds per liter (kPa*s/L)
Interval 0.741 to 2.14
|
1.213 Kilopascal* seconds per liter (kPa*s/L)
Interval 0.907 to 1.623
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 12) and Day 28Population: All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
iRaw is a measure of the resistance in an individual's airway derived from HRCT. It was measured at FRC and TLC. Data was collected at each time point for scan trimmed pairs: SCRD12, SCRD28 \& D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe \& left lower lobe) and 5 Regions (Upper, Lower, Central, Distal \& Total). For SCRD12 \& SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analyzed (represented by n=X1, X2 in the category title). This table presents the D12D28 scan trim pair data only.
Outcome measures
| Measure |
All NEMI
n=22 Participants
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
All NEMI
n=22 Participants
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
Placebo Via ELLIPTA
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
NEMI 700 mcg Via ELLIPTA
Participants were administered with NEMI 700 mcg once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
|---|---|---|---|---|
|
Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Lobes at Day 28
FRC,Scan Trimmed,Right Upper,Day 28,n=16,18
|
1.082 kPa*s/L
Interval 0.714 to 1.641
|
1.152 kPa*s/L
Interval 0.819 to 1.62
|
—
|
—
|
|
Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Lobes at Day 28
FRC,Scan Trimmed,Left Upper,Day 28,n=16,18
|
1.266 kPa*s/L
Interval 0.892 to 1.798
|
1.008 kPa*s/L
Interval 0.641 to 1.587
|
—
|
—
|
|
Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Lobes at Day 28
FRC,Scan Trimmed,Right Middle,Day 28,n=16,18
|
1.149 kPa*s/L
Interval 0.709 to 1.862
|
1.477 kPa*s/L
Interval 0.927 to 2.355
|
—
|
—
|
|
Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Lobes at Day 28
FRC,Scan Trimmed,Right Lower,Day 28,n=16,18
|
1.269 kPa*s/L
Interval 0.84 to 1.916
|
1.276 kPa*s/L
Interval 0.693 to 2.35
|
—
|
—
|
|
Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Lobes at Day 28
FRC,Scan Trimmed,Left Lower,Day 28,n=16,18
|
1.768 kPa*s/L
Interval 0.902 to 3.465
|
1.185 kPa*s/L
Interval 0.759 to 1.85
|
—
|
—
|
|
Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Lobes at Day 28
TLC,Scan Trimmed,Right Upper,Day 28,n=17,19
|
1.133 kPa*s/L
Interval 0.798 to 1.608
|
1.143 kPa*s/L
Interval 0.995 to 1.314
|
—
|
—
|
|
Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Lobes at Day 28
TLC,Scan Trimmed,Left Upper,Day 28,n=17,19
|
1.000 kPa*s/L
Interval 0.732 to 1.367
|
1.093 kPa*s/L
Interval 0.927 to 1.288
|
—
|
—
|
|
Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Lobes at Day 28
TLC,Scan Trimmed,Right Middle,Day 28,n=17,19
|
1.971 kPa*s/L
Interval 0.962 to 4.039
|
1.537 kPa*s/L
Interval 1.055 to 2.238
|
—
|
—
|
|
Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Lobes at Day 28
TLC,Scan Trimmed,Right Lower,Day 28,n=17,19
|
1.408 kPa*s/L
Interval 0.901 to 2.199
|
1.073 kPa*s/L
Interval 0.779 to 1.478
|
—
|
—
|
|
Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Lobes at Day 28
TLC,Scan Trimmed,Left Lower,Day 28,n=17,19
|
1.486 kPa*s/L
Interval 0.983 to 2.248
|
1.056 kPa*s/L
Interval 0.691 to 1.615
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Screening) and Days 12 and 28Population: All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
iRaw is a measure of the resistance in an individual's airway derived from HRCT. It was measured at FRC and TLC. Data was collected at each time point for scan trimmed pairs: SCRD12, SCRD28 \& D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe \& left lower lobe) and 5 Regions (Upper, Lower, Central, Distal \& Total). For SCRD12 \& SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analyzed (n=X1, X2 in the category title). This table presents the SCRD12 scan trim pair data (in rows with categories containing Scan Trimmed and Day 12) and SCRD28 scan trim pair data (in rows with categories containing Scan Trimmed and Day 28) only.
Outcome measures
| Measure |
All NEMI
n=22 Participants
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
All NEMI
n=22 Participants
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
Placebo Via ELLIPTA
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
NEMI 700 mcg Via ELLIPTA
Participants were administered with NEMI 700 mcg once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
|---|---|---|---|---|
|
Change From Baseline in iRaw at FRC and TLC for Individual Regions
TLC,Scan Trimmed,Upper,Day 12,n=20,18
|
1.142 kPa*s/L
Interval 0.888 to 1.469
|
1.167 kPa*s/L
Interval 0.727 to 1.872
|
—
|
—
|
|
Change From Baseline in iRaw at FRC and TLC for Individual Regions
TLC,Scan Trimmed,Total,Day 12,n=20,18
|
0.993 kPa*s/L
Interval 0.831 to 1.187
|
1.109 kPa*s/L
Interval 0.853 to 1.443
|
—
|
—
|
|
Change From Baseline in iRaw at FRC and TLC for Individual Regions
FRC,Scan Trimmed,Upper,Day 12,n=18,17
|
0.827 kPa*s/L
Interval 0.448 to 1.526
|
0.831 kPa*s/L
Interval 0.52 to 1.326
|
—
|
—
|
|
Change From Baseline in iRaw at FRC and TLC for Individual Regions
FRC,Scan Trimmed,Upper,Day 28,n=16,19
|
1.395 kPa*s/L
Interval 0.682 to 2.851
|
0.776 kPa*s/L
Interval 0.526 to 1.144
|
—
|
—
|
|
Change From Baseline in iRaw at FRC and TLC for Individual Regions
FRC,Scan Trimmed,Lower,Day 12,n=17,17
|
1.112 kPa*s/L
Interval 0.553 to 2.236
|
1.066 kPa*s/L
Interval 0.51 to 2.225
|
—
|
—
|
|
Change From Baseline in iRaw at FRC and TLC for Individual Regions
FRC,Scan Trimmed,Lower,Day 28,n=16,19
|
1.071 kPa*s/L
Interval 0.515 to 2.23
|
0.912 kPa*s/L
Interval 0.598 to 1.391
|
—
|
—
|
|
Change From Baseline in iRaw at FRC and TLC for Individual Regions
FRC,Scan Trimmed,Central,Day 12,n=18,17
|
0.932 kPa*s/L
Interval 0.637 to 1.364
|
0.888 kPa*s/L
Interval 0.729 to 1.082
|
—
|
—
|
|
Change From Baseline in iRaw at FRC and TLC for Individual Regions
FRC,Scan Trimmed,Central,Day 28,n=16,19
|
0.876 kPa*s/L
Interval 0.606 to 1.266
|
0.871 kPa*s/L
Interval 0.694 to 1.094
|
—
|
—
|
|
Change From Baseline in iRaw at FRC and TLC for Individual Regions
FRC,Scan Trimmed,Distal,Day 12,n=18,17
|
1.001 kPa*s/L
Interval 0.625 to 1.602
|
1.098 kPa*s/L
Interval 0.563 to 2.144
|
—
|
—
|
|
Change From Baseline in iRaw at FRC and TLC for Individual Regions
FRC,Scan Trimmed,Distal,Day 28,n=16,19
|
1.169 kPa*s/L
Interval 0.559 to 2.443
|
0.857 kPa*s/L
Interval 0.589 to 1.247
|
—
|
—
|
|
Change From Baseline in iRaw at FRC and TLC for Individual Regions
FRC,Scan Trimmed,Total,Day 12,n=18,17
|
0.985 kPa*s/L
Interval 0.673 to 1.441
|
0.972 kPa*s/L
Interval 0.711 to 1.329
|
—
|
—
|
|
Change From Baseline in iRaw at FRC and TLC for Individual Regions
FRC,Scan Trimmed,Total,Day 28,n=16,19
|
1.045 kPa*s/L
Interval 0.656 to 1.665
|
0.913 kPa*s/L
Interval 0.701 to 1.19
|
—
|
—
|
|
Change From Baseline in iRaw at FRC and TLC for Individual Regions
TLC,Scan Trimmed,Upper,Day 28,n=18,20
|
1.540 kPa*s/L
Interval 1.106 to 2.145
|
1.271 kPa*s/L
Interval 0.956 to 1.69
|
—
|
—
|
|
Change From Baseline in iRaw at FRC and TLC for Individual Regions
TLC,Scan Trimmed,Lower,Day 12,n=20,18
|
0.860 kPa*s/L
Interval 0.649 to 1.141
|
1.206 kPa*s/L
Interval 0.835 to 1.741
|
—
|
—
|
|
Change From Baseline in iRaw at FRC and TLC for Individual Regions
TLC,Scan Trimmed,Lower,Day 28,n=18,20
|
1.142 kPa*s/L
Interval 0.734 to 1.775
|
1.315 kPa*s/L
Interval 1.004 to 1.723
|
—
|
—
|
|
Change From Baseline in iRaw at FRC and TLC for Individual Regions
TLC,Scan Trimmed,Central,Day 12,n=20,18
|
0.987 kPa*s/L
Interval 0.876 to 1.111
|
1.005 kPa*s/L
Interval 0.882 to 1.146
|
—
|
—
|
|
Change From Baseline in iRaw at FRC and TLC for Individual Regions
TLC,Scan Trimmed,Central,Day 28,n=18,20
|
0.985 kPa*s/L
Interval 0.914 to 1.061
|
1.057 kPa*s/L
Interval 0.943 to 1.186
|
—
|
—
|
|
Change From Baseline in iRaw at FRC and TLC for Individual Regions
TLC,Scan Trimmed,Distal,Day 12,n=20,18
|
0.959 kPa*s/L
Interval 0.726 to 1.268
|
1.278 kPa*s/L
Interval 0.824 to 1.983
|
—
|
—
|
|
Change From Baseline in iRaw at FRC and TLC for Individual Regions
TLC,Scan Trimmed,Distal,Day 28,n=18,20
|
1.332 kPa*s/L
Interval 0.869 to 2.04
|
1.288 kPa*s/L
Interval 0.993 to 1.669
|
—
|
—
|
|
Change From Baseline in iRaw at FRC and TLC for Individual Regions
TLC,Scan Trimmed,Total,Day 28,n=18,20
|
1.196 kPa*s/L
Interval 0.959 to 1.492
|
1.202 kPa*s/L
Interval 0.99 to 1.46
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 12) and Day 28Population: All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
iRaw is a measure of the resistance in an individual's airway derived from HRCT. It was measured at FRC and TLC. Data was collected at each time point for scan trimmed pairs: SCRD12, SCRD28 \& D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe \& left lower lobe) and 5 Regions (Upper, Lower, Central, Distal \& Total). For SCRD12 \& SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analyzed (represented by n=X1, X2 in the category title). This table presents the D12D28 scan trim pair data only.
Outcome measures
| Measure |
All NEMI
n=22 Participants
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
All NEMI
n=22 Participants
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
Placebo Via ELLIPTA
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
NEMI 700 mcg Via ELLIPTA
Participants were administered with NEMI 700 mcg once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
|---|---|---|---|---|
|
Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Regions at Day 28
TLC,Scan Trimmed,Total,Day 28,n=17,19
|
1.321 kPa*s/L
Interval 0.998 to 1.749
|
1.085 kPa*s/L
Interval 0.933 to 1.263
|
—
|
—
|
|
Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Regions at Day 28
FRC,Scan Trimmed,Upper,Day 28,n=16,18
|
1.221 kPa*s/L
Interval 0.87 to 1.715
|
1.266 kPa*s/L
Interval 0.848 to 1.891
|
—
|
—
|
|
Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Regions at Day 28
FRC,Scan Trimmed,Lower,Day 28,n=16,18
|
1.531 kPa*s/L
Interval 0.937 to 2.499
|
1.278 kPa*s/L
Interval 0.774 to 2.112
|
—
|
—
|
|
Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Regions at Day 28
FRC,Scan Trimmed,Central,Day 28,n=16,18
|
0.989 kPa*s/L
Interval 0.873 to 1.121
|
0.926 kPa*s/L
Interval 0.697 to 1.231
|
—
|
—
|
|
Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Regions at Day 28
FRC,Scan Trimmed,Distal,Day 28,n=16,18
|
1.373 kPa*s/L
Interval 0.986 to 1.912
|
1.235 kPa*s/L
Interval 0.856 to 1.781
|
—
|
—
|
|
Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Regions at Day 28
FRC,Scan Trimmed,Total,Day 28,n=16,18
|
1.157 kPa*s/L
Interval 0.94 to 1.425
|
1.001 kPa*s/L
Interval 0.714 to 1.402
|
—
|
—
|
|
Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Regions at Day 28
TLC,Scan Trimmed,Upper,Day 28,n=17,19
|
1.473 kPa*s/L
Interval 0.938 to 2.313
|
1.172 kPa*s/L
Interval 1.052 to 1.306
|
—
|
—
|
|
Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Regions at Day 28
TLC,Scan Trimmed,Lower,Day 28,n=17,19
|
1.422 kPa*s/L
Interval 0.942 to 2.148
|
1.089 kPa*s/L
Interval 0.816 to 1.454
|
—
|
—
|
|
Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Regions at Day 28
TLC,Scan Trimmed,Central,Day 28,n=17,19
|
0.986 kPa*s/L
Interval 0.862 to 1.129
|
1.044 kPa*s/L
Interval 0.937 to 1.162
|
—
|
—
|
|
Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Regions at Day 28
TLC,Scan Trimmed,Distal,Day 28,n=17,19
|
1.712 kPa*s/L
Interval 1.119 to 2.618
|
1.079 kPa*s/L
Interval 0.883 to 1.319
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Screening) and Days 12 and 28Population: All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
siRaw is a measure of the resistance in an individual's airway corrected for their lobar volume derived from the HRCT. It was measured at FRC and TLC. Data was collected at each time point for scan trimmed pairs: SCRD12, SCRD28 \& D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe \& left lower lobe) and 5 Regions (Upper, Lower, Central, Distal \& Total). For SCRD12 \& SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analysed (represented by n=X1, X2 in the category title). This table presents the SCRD12 scan trim pair data (in rows with categories containing Scan Trimmed and Day 12) and SCRD28 scan trim pair data (in rows with categories containing Scan Trimmed and Day 28) only.
Outcome measures
| Measure |
All NEMI
n=22 Participants
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
All NEMI
n=22 Participants
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
Placebo Via ELLIPTA
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
NEMI 700 mcg Via ELLIPTA
Participants were administered with NEMI 700 mcg once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
|---|---|---|---|---|
|
Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes
FRC,Scan Trimmed,Left Upper,Day 28,n=16,19
|
1.139 kPa*s
Interval 0.586 to 2.215
|
0.687 kPa*s
Interval 0.457 to 1.032
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes
FRC,Scan Trimmed,Right Upper,Day 12,n=17,16
|
1.117 kPa*s
Interval 0.627 to 1.989
|
0.961 kPa*s
Interval 0.539 to 1.711
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes
FRC,Scan Trimmed,Right Upper,Day 28,n=16,18
|
1.200 kPa*s
Interval 0.574 to 2.51
|
0.923 kPa*s
Interval 0.599 to 1.424
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes
FRC,Scan Trimmed,Left Upper,Day 12,n=18,17
|
1.053 kPa*s
Interval 0.642 to 1.726
|
0.945 kPa*s
Interval 0.604 to 1.479
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes
FRC,Scan Trimmed,Right Middle,Day 12,n=17,16
|
0.496 kPa*s
Interval 0.163 to 1.511
|
1.022 kPa*s
Interval 0.593 to 1.761
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes
FRC,Scan Trimmed,Right Middle,Day 28,n=16,18
|
1.259 kPa*s
Interval 0.521 to 3.043
|
1.424 kPa*s
Interval 0.836 to 2.424
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes
FRC,Scan Trimmed,Right Lower,Day 12,n=17,17
|
0.921 kPa*s
Interval 0.362 to 2.342
|
1.121 kPa*s
Interval 0.715 to 1.758
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes
FRC,Scan Trimmed,Right Lower,Day 28,n=16,19
|
0.688 kPa*s
Interval 0.257 to 1.84
|
0.920 kPa*s
Interval 0.521 to 1.624
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes
FRC,Scan Trimmed,Left Lower,Day 12,n=17,17
|
1.075 kPa*s
Interval 0.648 to 1.785
|
0.884 kPa*s
Interval 0.386 to 2.021
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes
FRC,Scan Trimmed,Left Lower,Day 28,n=16,19
|
1.573 kPa*s
Interval 0.669 to 3.701
|
0.876 kPa*s
Interval 0.634 to 1.212
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes
TLC,Scan Trimmed,Right Upper,Day 12,n=19,17
|
1.037 kPa*s
Interval 0.788 to 1.364
|
1.035 kPa*s
Interval 0.711 to 1.509
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes
TLC,Scan Trimmed,Right Upper,Day 28,n=18,19
|
1.292 kPa*s
Interval 0.992 to 1.684
|
1.262 kPa*s
Interval 0.912 to 1.747
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes
TLC,Scan Trimmed,Left Upper,Day 12,n=20,18
|
1.133 kPa*s
Interval 0.946 to 1.358
|
1.064 kPa*s
Interval 0.659 to 1.72
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes
TLC,Scan Trimmed,Left Upper,Day 28,n=18,20
|
1.203 kPa*s
Interval 0.955 to 1.515
|
1.145 kPa*s
Interval 0.843 to 1.554
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes
TLC,Scan Trimmed,Right Middle,Day 12,n=18,17
|
1.094 kPa*s
Interval 0.73 to 1.639
|
1.101 kPa*s
Interval 0.69 to 1.758
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes
TLC,Scan Trimmed,Right Middle,Day 28,n=18,19
|
1.575 kPa*s
Interval 0.965 to 2.57
|
1.557 kPa*s
Interval 0.955 to 2.538
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes
TLC,Scan Trimmed,Right Lower,Day 12,n=20,18
|
0.747 kPa*s
Interval 0.498 to 1.12
|
1.290 kPa*s
Interval 0.842 to 1.976
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes
TLC,Scan Trimmed,Right Lower,Day 28,n=18,20
|
1.161 kPa*s
Interval 0.814 to 1.654
|
1.427 kPa*s
Interval 1.065 to 1.912
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes
TLC,Scan Trimmed,Left Lower,Day 12,n=20,18
|
1.018 kPa*s
Interval 0.81 to 1.278
|
1.118 kPa*s
Interval 0.715 to 1.747
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes
TLC,Scan Trimmed,Left Lower,Day 28,n=18,20
|
1.240 kPa*s
Interval 0.735 to 2.092
|
1.178 kPa*s
Interval 0.876 to 1.584
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 12) and Day 28Population: All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
siRaw is a measure of the resistance in an individual's airway corrected for their lobar volume derived from the HRCT. It was measured at FRC and TLC. Data was collected at each time point for scan trimmed pairs: SCRD12, SCRD28 \& D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe \& left lower lobe) and 5 Regions (Upper, Lower, Central, Distal \& Total). For SCRD12 \& SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analysed (represented by n=X1, X2 in the category title). This table presents the D12D28 scan trim pair data only.
Outcome measures
| Measure |
All NEMI
n=22 Participants
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
All NEMI
n=22 Participants
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
Placebo Via ELLIPTA
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
NEMI 700 mcg Via ELLIPTA
Participants were administered with NEMI 700 mcg once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
|---|---|---|---|---|
|
Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes at Day 28
FRC,Scan Trimmed,Right Upper,Day 28,n=16,17
|
1.079 kPa*s
Interval 0.711 to 1.636
|
1.073 kPa*s
Interval 0.794 to 1.451
|
—
|
—
|
|
Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes at Day 28
FRC,Scan Trimmed,Left Upper,Day 28,n=16,18
|
1.249 kPa*s
Interval 0.886 to 1.76
|
1.011 kPa*s
Interval 0.653 to 1.566
|
—
|
—
|
|
Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes at Day 28
FRC,Scan Trimmed,Right Middle,Day 28,n=16,17
|
1.097 kPa*s
Interval 0.647 to 1.859
|
1.354 kPa*s
Interval 0.885 to 2.07
|
—
|
—
|
|
Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes at Day 28
FRC,Scan Trimmed,Right Lower,Day 28,n=16,18
|
1.241 kPa*s
Interval 0.845 to 1.822
|
1.261 kPa*s
Interval 0.706 to 2.252
|
—
|
—
|
|
Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes at Day 28
FRC,Scan Trimmed,Left Lower,Day 28,n=16,18
|
1.760 kPa*s
Interval 0.893 to 3.47
|
1.165 kPa*s
Interval 0.755 to 1.798
|
—
|
—
|
|
Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes at Day 28
TLC,Scan Trimmed,Right Upper,Day 28,n=17,18
|
1.132 kPa*s
Interval 0.796 to 1.611
|
1.142 kPa*s
Interval 0.977 to 1.336
|
—
|
—
|
|
Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes at Day 28
TLC,Scan Trimmed,Left Upper,Day 28,n=17,19
|
0.992 kPa*s
Interval 0.73 to 1.349
|
1.089 kPa*s
Interval 0.921 to 1.288
|
—
|
—
|
|
Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes at Day 28
TLC,Scan Trimmed,Right Middle,Day 28,n=17,18
|
1.915 kPa*s
Interval 0.956 to 3.834
|
1.564 kPa*s
Interval 1.042 to 2.347
|
—
|
—
|
|
Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes at Day 28
TLC,Scan Trimmed,Right Lower,Day 28,n=17,19
|
1.380 kPa*s
Interval 0.894 to 2.13
|
1.064 kPa*s
Interval 0.783 to 1.447
|
—
|
—
|
|
Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes at Day 28
TLC,Scan Trimmed,Left Lower,Day 28,n=17,19
|
1.453 kPa*s
Interval 0.977 to 2.161
|
1.042 kPa*s
Interval 0.683 to 1.59
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Screening) and Days 12 and 28Population: All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
siRaw is a measure of the resistance in an individual's airway corrected for their lobar volume derived from the HRCT. It was measured at FRC and TLC. Data was collected at each time point for scan trimmed pairs: SCRD12, SCRD28 \& D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe \& left lower lobe) and 5 Regions (Upper, Lower, Central, Distal \& Total). For SCRD12 \& SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analysed (represented by n=X1, X2 in the category title). This table presents the SCRD12 scan trim pair data (in rows with categories containing Scan Trimmed and Day 12) and SCRD28 scan trim pair data (in rows with categories containing Scan Trimmed and Day 28) only.
Outcome measures
| Measure |
All NEMI
n=22 Participants
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
All NEMI
n=22 Participants
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
Placebo Via ELLIPTA
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
NEMI 700 mcg Via ELLIPTA
Participants were administered with NEMI 700 mcg once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
|---|---|---|---|---|
|
Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions
FRC,Scan Trimmed,Upper,Day 12,n=18,17
|
0.820 kPa*s
Interval 0.443 to 1.517
|
0.828 kPa*s
Interval 0.531 to 1.292
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions
FRC,Scan Trimmed,Upper,Day 28,n=16,19
|
1.377 kPa*s
Interval 0.679 to 2.793
|
0.784 kPa*s
Interval 0.546 to 1.124
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions
FRC,Scan Trimmed,Lower,Day 12,n=17,17
|
1.118 kPa*s
Interval 0.559 to 2.239
|
1.043 kPa*s
Interval 0.516 to 2.109
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions
FRC,Scan Trimmed,Lower,Day 28,n=16,19
|
1.073 kPa*s
Interval 0.529 to 2.177
|
0.891 kPa*s
Interval 0.601 to 1.321
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions
FRC,Scan Trimmed,Central,Day 12,n=18,17
|
0.931 kPa*s
Interval 0.634 to 1.367
|
0.878 kPa*s
Interval 0.734 to 1.05
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions
FRC,Scan Trimmed,Central,Day 28,n=16,19
|
0.870 kPa*s
Interval 0.598 to 1.265
|
0.867 kPa*s
Interval 0.709 to 1.06
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions
FRC,Scan Trimmed,Distal,Day 12,n=18,17
|
0.999 kPa*s
Interval 0.617 to 1.617
|
1.085 kPa*s
Interval 0.567 to 2.077
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions
FRC,Scan Trimmed,Distal,Day 28,n=16,19
|
1.161 kPa*s
Interval 0.566 to 2.38
|
0.853 kPa*s
Interval 0.604 to 1.204
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions
FRC,Scan Trimmed,Total,Day 12,n=18,17
|
0.983 kPa*s
Interval 0.674 to 1.435
|
0.961 kPa*s
Interval 0.717 to 1.287
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions
FRC,Scan Trimmed,Total,Day 28,n=16,19
|
1.038 kPa*s
Interval 0.656 to 1.641
|
0.909 kPa*s
Interval 0.719 to 1.15
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions
TLC,Scan Trimmed,Upper,Day 12,n=20,18
|
1.139 kPa*s
Interval 0.886 to 1.464
|
1.156 kPa*s
Interval 0.723 to 1.849
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions
TLC,Scan Trimmed,Upper,Day 28,n=18,20
|
1.524 kPa*s
Interval 1.101 to 2.111
|
1.257 kPa*s
Interval 0.95 to 1.664
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions
TLC,Scan Trimmed,Lower,Day 12,n=20,18
|
0.878 kPa*s
Interval 0.665 to 1.161
|
1.179 kPa*s
Interval 0.822 to 1.69
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions
TLC,Scan Trimmed,Lower,Day 28,n=18,20
|
1.142 kPa*s
Interval 0.74 to 1.76
|
1.282 kPa*s
Interval 0.982 to 1.673
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions
TLC,Scan Trimmed,Central,Day 12,n=20,18
|
0.994 kPa*s
Interval 0.883 to 1.12
|
0.990 kPa*s
Interval 0.87 to 1.127
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions
TLC,Scan Trimmed,Central,Day 28,n=18,20
|
0.978 kPa*s
Interval 0.904 to 1.059
|
1.039 kPa*s
Interval 0.931 to 1.16
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions
TLC,Scan Trimmed,Distal,Day 12,n=20,18
|
0.966 kPa*s
Interval 0.735 to 1.271
|
1.259 kPa*s
Interval 0.815 to 1.946
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions
TLC,Scan Trimmed,Distal,Day 28,n=18,20
|
1.323 kPa*s
Interval 0.869 to 2.014
|
1.266 kPa*s
Interval 0.981 to 1.633
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions
TLC,Scan Trimmed,Total,Day 12,n=20,18
|
1.000 kPa*s
Interval 0.84 to 1.191
|
1.093 kPa*s
Interval 0.844 to 1.416
|
—
|
—
|
|
Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions
TLC,Scan Trimmed,Total,Day 28,n=18,20
|
1.188 kPa*s
Interval 0.958 to 1.473
|
1.181 kPa*s
Interval 0.978 to 1.427
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 12) and Day 28Population: All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
siRaw is a measure of the resistance in an individual's airway corrected for their lobar volume derived from the HRCT. It was measured at FRC and TLC. Data was collected at each time point for scan trimmed pairs: SCRD12, SCRD28 \& D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe \& left lower lobe) and 5 Regions (Upper, Lower, Central, Distal \& Total). For SCRD12 \& SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analysed (represented by n=X1, X2 in the category title). This table presents the D12D28 scan trim pair data only.
Outcome measures
| Measure |
All NEMI
n=22 Participants
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
All NEMI
n=22 Participants
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
Placebo Via ELLIPTA
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
NEMI 700 mcg Via ELLIPTA
Participants were administered with NEMI 700 mcg once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
|---|---|---|---|---|
|
Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions at Day 28
TLC,Scan Trimmed,Upper,Day 28,n=17,19
|
1.465 kPa*s
Interval 0.934 to 2.3
|
1.169 kPa*s
Interval 1.05 to 1.302
|
—
|
—
|
|
Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions at Day 28
FRC,Scan Trimmed,Upper,Day 28,n=16,18
|
1.211 kPa*s
Interval 0.852 to 1.722
|
1.265 kPa*s
Interval 0.872 to 1.836
|
—
|
—
|
|
Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions at Day 28
FRC,Scan Trimmed,Lower,Day 28,n=16,18
|
1.508 kPa*s
Interval 0.929 to 2.448
|
1.260 kPa*s
Interval 0.778 to 2.041
|
—
|
—
|
|
Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions at Day 28
FRC,Scan Trimmed,Central,Day 28,n=16,18
|
0.977 kPa*s
Interval 0.861 to 1.11
|
0.921 kPa*s
Interval 0.703 to 1.206
|
—
|
—
|
|
Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions at Day 28
FRC,Scan Trimmed,Distal,Day 28,n=16,18
|
1.356 kPa*s
Interval 0.98 to 1.877
|
1.227 kPa*s
Interval 0.876 to 1.72
|
—
|
—
|
|
Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions at Day 28
FRC,Scan Trimmed,Total,Day 28,n=16,18
|
1.144 kPa*s
Interval 0.922 to 1.418
|
0.995 kPa*s
Interval 0.723 to 1.368
|
—
|
—
|
|
Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions at Day 28
TLC,Scan Trimmed,Lower,Day 28,n=17,19
|
1.392 kPa*s
Interval 0.936 to 2.072
|
1.079 kPa*s
Interval 0.813 to 1.43
|
—
|
—
|
|
Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions at Day 28
TLC,Scan Trimmed,Central,Day 28,n=17,19
|
0.973 kPa*s
Interval 0.853 to 1.111
|
1.038 kPa*s
Interval 0.935 to 1.153
|
—
|
—
|
|
Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions at Day 28
TLC,Scan Trimmed,Distal,Day 28,n=17,19
|
1.689 kPa*s
Interval 1.111 to 2.567
|
1.073 kPa*s
Interval 0.882 to 1.305
|
—
|
—
|
|
Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions at Day 28
TLC,Scan Trimmed,Total,Day 28,n=17,19
|
1.303 kPa*s
Interval 0.99 to 1.717
|
1.079 kPa*s
Interval 0.932 to 1.25
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Screening) and Days 12 and 28Population: All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
Change from Baseline in lung lobar volumes was measured at FRC and TLC scan conditions. Data was collected at longitudinal time points: Baseline (Screening), Day 12 and Day 28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe \& left lower lobe). The value at Screening was considered as Baseline. Change from baseline is the post-Baseline value minus the Baseline value. The study had a protocol amendment to reflect changes in manufacturing device from DISKUS to ELLIPTA after study had been initiated, but the 2 treatment arms remained the same i.e. Placebo and NEMI.There was no intent to compare two devices.
Outcome measures
| Measure |
All NEMI
n=22 Participants
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
All NEMI
n=22 Participants
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
Placebo Via ELLIPTA
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
NEMI 700 mcg Via ELLIPTA
Participants were administered with NEMI 700 mcg once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
|---|---|---|---|---|
|
Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Lobes
FRC,Right Upper,Day 12,n=17,16
|
0.989 Liters
Interval 0.921 to 1.063
|
0.971 Liters
Interval 0.935 to 1.009
|
—
|
—
|
|
Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Lobes
FRC,Right Upper,Day 28,n=16,18
|
0.989 Liters
Interval 0.929 to 1.053
|
0.999 Liters
Interval 0.952 to 1.048
|
—
|
—
|
|
Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Lobes
FRC,Left Upper,Day 12,n=18,17
|
0.995 Liters
Interval 0.938 to 1.056
|
0.993 Liters
Interval 0.924 to 1.068
|
—
|
—
|
|
Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Lobes
FRC,Left Upper,Day 28,n=16,19
|
0.990 Liters
Interval 0.935 to 1.048
|
1.008 Liters
Interval 0.955 to 1.064
|
—
|
—
|
|
Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Lobes
FRC,Right Middle,Day 12,n=17,16
|
0.931 Liters
Interval 0.819 to 1.057
|
0.979 Liters
Interval 0.949 to 1.01
|
—
|
—
|
|
Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Lobes
FRC,Right Middle,Day 28,n=16,18
|
0.887 Liters
Interval 0.708 to 1.111
|
1.010 Liters
Interval 0.964 to 1.06
|
—
|
—
|
|
Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Lobes
FRC,Right Lower,Day 12,n=18,17
|
1.021 Liters
Interval 0.928 to 1.123
|
0.976 Liters
Interval 0.908 to 1.048
|
—
|
—
|
|
Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Lobes
FRC,Right Lower,Day 28,n=16,19
|
1.009 Liters
Interval 0.907 to 1.124
|
0.984 Liters
Interval 0.927 to 1.044
|
—
|
—
|
|
Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Lobes
FRC,Left Lower,Day 12,n=18,17
|
0.996 Liters
Interval 0.917 to 1.082
|
0.979 Liters
Interval 0.905 to 1.059
|
—
|
—
|
|
Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Lobes
FRC,Left Lower,Day 28,n=16,19
|
0.998 Liters
Interval 0.915 to 1.089
|
0.969 Liters
Interval 0.898 to 1.045
|
—
|
—
|
|
Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Lobes
TLC,Right Upper,Day 12,n=19,17
|
0.991 Liters
Interval 0.964 to 1.02
|
0.992 Liters
Interval 0.976 to 1.007
|
—
|
—
|
|
Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Lobes
TLC,Right Upper,Day 28,n=18,19
|
0.989 Liters
Interval 0.967 to 1.012
|
0.984 Liters
Interval 0.965 to 1.004
|
—
|
—
|
|
Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Lobes
TLC,Left Upper,Day 12,n=20,18
|
1.003 Liters
Interval 0.985 to 1.022
|
0.990 Liters
Interval 0.975 to 1.005
|
—
|
—
|
|
Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Lobes
TLC,Left Upper,Day 28,n=18,20
|
0.992 Liters
Interval 0.978 to 1.008
|
0.987 Liters
Interval 0.968 to 1.006
|
—
|
—
|
|
Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Lobes
TLC,Right Middle,Day 12,n=19,17
|
0.935 Liters
Interval 0.815 to 1.072
|
0.990 Liters
Interval 0.96 to 1.022
|
—
|
—
|
|
Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Lobes
TLC,Right Middle,Day 28,n=18,19
|
0.900 Liters
Interval 0.741 to 1.094
|
0.998 Liters
Interval 0.969 to 1.028
|
—
|
—
|
|
Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Lobes
TLC,Right Lower,Day 12,n=20,18
|
1.027 Liters
Interval 0.981 to 1.076
|
0.973 Liters
Interval 0.95 to 0.997
|
—
|
—
|
|
Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Lobes
TLC,Right Lower,Day 28,n=18,20
|
1.016 Liters
Interval 0.963 to 1.072
|
0.975 Liters
Interval 0.946 to 1.005
|
—
|
—
|
|
Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Lobes
TLC,Left Lower,Day 12,n=20,18
|
1.015 Liters
Interval 0.982 to 1.048
|
0.977 Liters
Interval 0.937 to 1.019
|
—
|
—
|
|
Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Lobes
TLC,Left Lower,Day 28,n=18,20
|
0.985 Liters
Interval 0.953 to 1.018
|
0.971 Liters
Interval 0.929 to 1.015
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Screening) and Days 12 and 28Population: All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
Change from Baseline in lung lobar volumes was measured at FRC and TLC scan conditions. Data was collected at longitudinal time points: Baseline (Screening), Day 12 and Day 28. At each time point it was measure at 5 Regions (Upper, Lower, Central, Distal \& Total). The value at Screening was considered as Baseline. Change from Baseline is the post-Baseline value minus the Baseline value. The study had a protocol amendment to reflect changes in manufacturing device from DISKUS to ELLIPTA after study had been initiated, but the 2 treatment arms remained the same i.e. Placebo and NEMI.There was no intent to compare two devices.
Outcome measures
| Measure |
All NEMI
n=22 Participants
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
All NEMI
n=22 Participants
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
Placebo Via ELLIPTA
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
NEMI 700 mcg Via ELLIPTA
Participants were administered with NEMI 700 mcg once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
|---|---|---|---|---|
|
Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Regions
FRC,Upper,Day 12,n=18,17
|
0.991 Liters
Interval 0.935 to 1.051
|
0.997 Liters
Interval 0.932 to 1.068
|
—
|
—
|
|
Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Regions
FRC,Upper,Day 28,n=16,19
|
0.987 Liters
Interval 0.932 to 1.045
|
1.010 Liters
Interval 0.961 to 1.061
|
—
|
—
|
|
Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Regions
FRC,Lower,Day 12,n=18,17
|
1.008 Liters
Interval 0.923 to 1.1
|
0.979 Liters
Interval 0.911 to 1.051
|
—
|
—
|
|
Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Regions
FRC,Lower,Day 28,n=16,19
|
1.002 Liters
Interval 0.912 to 1.101
|
0.978 Liters
Interval 0.918 to 1.041
|
—
|
—
|
|
Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Regions
FRC,Total,Day 12,n=18,17
|
0.998 Liters
Interval 0.931 to 1.07
|
0.988 Liters
Interval 0.925 to 1.056
|
—
|
—
|
|
Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Regions
FRC,Total,Day 28,n=16,19
|
0.993 Liters
Interval 0.925 to 1.065
|
0.995 Liters
Interval 0.944 to 1.049
|
—
|
—
|
|
Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Regions
TLC,Upper,Day 12,n=20,18
|
0.997 Liters
Interval 0.98 to 1.013
|
0.991 Liters
Interval 0.978 to 1.004
|
—
|
—
|
|
Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Regions
TLC,Upper,Day 28,n=18,20
|
0.990 Liters
Interval 0.978 to 1.002
|
0.989 Liters
Interval 0.972 to 1.006
|
—
|
—
|
|
Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Regions
TLC,Lower,Day 12,n=20,18
|
1.021 Liters
Interval 0.985 to 1.057
|
0.977 Liters
Interval 0.954 to 1.001
|
—
|
—
|
|
Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Regions
TLC,Lower,Day 28,n=18,20
|
1.000 Liters
Interval 0.961 to 1.04
|
0.975 Liters
Interval 0.947 to 1.004
|
—
|
—
|
|
Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Regions
TLC,Total,Day 12,n=20,18
|
1.008 Liters
Interval 0.985 to 1.03
|
0.985 Liters
Interval 0.97 to 1.0
|
—
|
—
|
|
Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Regions
TLC,Total,Day 28,n=18,20
|
0.993 Liters
Interval 0.972 to 1.015
|
0.983 Liters
Interval 0.962 to 1.004
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Screening) and Days 12 and 28Population: All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
Trachea length and diameter was derived from HRCT. It was measured at both FRC and TLC scan conditions. The value at Screening was considered as Baseline. Change from Baseline is the post-Baseline value minus the Baseline value. The change from Baseline data is presented for Day 12 and Day 28 for trachea length and diameter. The study had a protocol amendment to reflect changes in manufacturing device from DISKUS to ELLIPTA after study had been initiated, but the 2 treatment arms remained the same i.e. Placebo and NEMI.There was no intent to compare two devices.
Outcome measures
| Measure |
All NEMI
n=22 Participants
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
All NEMI
n=22 Participants
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
Placebo Via ELLIPTA
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
NEMI 700 mcg Via ELLIPTA
Participants were administered with NEMI 700 mcg once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
|---|---|---|---|---|
|
Change From Baseline in Trachea Length and Diameter at FRC and TLC
FRC,Length,Day 12,n=18,17
|
0.094 Millimeters
Standard Deviation 7.2507
|
0.972 Millimeters
Standard Deviation 6.5552
|
—
|
—
|
|
Change From Baseline in Trachea Length and Diameter at FRC and TLC
FRC,Length,Day 28,n=16,19
|
0.796 Millimeters
Standard Deviation 7.7795
|
0.281 Millimeters
Standard Deviation 5.1808
|
—
|
—
|
|
Change From Baseline in Trachea Length and Diameter at FRC and TLC
FRC,Diameter,Day 12,n=18,17
|
0.225 Millimeters
Standard Deviation 1.3641
|
0.252 Millimeters
Standard Deviation 1.0023
|
—
|
—
|
|
Change From Baseline in Trachea Length and Diameter at FRC and TLC
FRC,Diameter,Day 28,n=16,19
|
0.225 Millimeters
Standard Deviation 1.3812
|
0.116 Millimeters
Standard Deviation 1.1600
|
—
|
—
|
|
Change From Baseline in Trachea Length and Diameter at FRC and TLC
TLC,Length,Day 12,n=20,18
|
-0.164 Millimeters
Standard Deviation 2.8331
|
0.827 Millimeters
Standard Deviation 3.1842
|
—
|
—
|
|
Change From Baseline in Trachea Length and Diameter at FRC and TLC
TLC,Length,Day 28,n=18,20
|
-0.094 Millimeters
Standard Deviation 2.8480
|
0.069 Millimeters
Standard Deviation 3.4882
|
—
|
—
|
|
Change From Baseline in Trachea Length and Diameter at FRC and TLC
TLC,Diameter,Day 12,n=20,18
|
0.134 Millimeters
Standard Deviation 0.4670
|
0.070 Millimeters
Standard Deviation 0.4222
|
—
|
—
|
|
Change From Baseline in Trachea Length and Diameter at FRC and TLC
TLC,Diameter,Day 28,n=18,20
|
0.076 Millimeters
Standard Deviation 0.4751
|
-0.188 Millimeters
Standard Deviation 0.4983
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and up to Day 84Population: All Subjects Population.
PEF measurements were taken (in triplicate) daily in the morning before dose administration, as soon as it is safe for the participant to do so. The best/highest result was recorded. Participants were provided with a handheld device. Baseline here is defined as average of Day 1 to Day 3. Change from Baseline is the post-Baseline value minus the Baseline value. The study had a protocol amendment to reflect changes in manufacturing device from DISKUS to ELLIPTA after study had been initiated, but the 2 treatment arms remained the same i.e. Placebo and NEMI. There was no intent to compare two devices.
Outcome measures
| Measure |
All NEMI
n=22 Participants
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
All NEMI
n=22 Participants
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
Placebo Via ELLIPTA
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
NEMI 700 mcg Via ELLIPTA
Participants were administered with NEMI 700 mcg once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
|---|---|---|---|---|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 4
|
2.5 Liters per minute
Interval -3.0 to 11.4
|
4.1 Liters per minute
Interval -5.4 to 13.7
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 5
|
-3.0 Liters per minute
Interval -12.8 to 6.8
|
6.3 Liters per minute
Interval -4.1 to 16.8
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 6
|
7.3 Liters per minute
Interval -3.7 to 18.4
|
7.5 Liters per minute
Interval -6.2 to 21.3
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 7
|
8.1 Liters per minute
Interval -3.0 to 19.3
|
11.3 Liters per minute
Interval -1.3 to 24.0
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 8
|
0.8 Liters per minute
Interval -12.7 to 14.4
|
8.2 Liters per minute
Interval -5.3 to 21.8
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 9
|
10.0 Liters per minute
Interval -5.5 to 25.7
|
17.7 Liters per minute
Interval -1.4 to 37.0
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 10
|
12.9 Liters per minute
Interval -2.2 to 28.2
|
15.2 Liters per minute
Interval 2.8 to 27.6
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 11
|
14.1 Liters per minute
Interval -3.3 to 31.5
|
21.1 Liters per minute
Interval 1.2 to 41.0
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 12
|
6.2 Liters per minute
Interval -11.2 to 23.8
|
20.4 Liters per minute
Interval 2.2 to 38.7
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 13
|
21.0 Liters per minute
Interval -4.5 to 46.6
|
18.8 Liters per minute
Interval -3.1 to 40.8
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 14
|
9.4 Liters per minute
Interval -11.7 to 30.7
|
15.3 Liters per minute
Interval -0.2 to 30.8
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 15
|
17.7 Liters per minute
Interval -2.3 to 37.7
|
10.8 Liters per minute
Interval -6.2 to 28.0
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 16
|
14.1 Liters per minute
Interval -10.7 to 39.0
|
12.5 Liters per minute
Interval -1.8 to 26.8
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 17
|
17.6 Liters per minute
Interval -3.9 to 39.3
|
11.5 Liters per minute
Interval -1.7 to 24.7
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 18
|
11.8 Liters per minute
Interval -10.6 to 34.3
|
11.9 Liters per minute
Interval -3.7 to 27.5
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 19
|
12.9 Liters per minute
Interval -4.1 to 30.1
|
7.1 Liters per minute
Interval -7.2 to 21.5
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 20
|
6.4 Liters per minute
Interval -16.5 to 29.4
|
3.3 Liters per minute
Interval -9.3 to 16.0
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 21
|
20.1 Liters per minute
Interval 4.5 to 35.6
|
4.1 Liters per minute
Interval -7.8 to 16.1
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 22
|
10.7 Liters per minute
Interval -11.0 to 32.5
|
6.2 Liters per minute
Interval -5.0 to 17.6
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 23
|
16.0 Liters per minute
Interval -5.2 to 37.3
|
2.8 Liters per minute
Interval -7.3 to 13.1
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 24
|
19.0 Liters per minute
Interval -5.3 to 43.5
|
6.9 Liters per minute
Interval -7.6 to 21.4
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 25
|
23.8 Liters per minute
Interval 2.9 to 44.7
|
11.6 Liters per minute
Interval -2.8 to 26.1
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 26
|
20.8 Liters per minute
Interval 0.8 to 40.7
|
14.4 Liters per minute
Interval -0.9 to 29.7
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 27
|
29.1 Liters per minute
Interval 3.8 to 54.5
|
17.6 Liters per minute
Interval -5.4 to 40.7
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 28
|
19.3 Liters per minute
Interval -2.7 to 41.4
|
11.2 Liters per minute
Interval -7.9 to 30.4
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 29
|
20.8 Liters per minute
Interval -3.5 to 45.2
|
13.8 Liters per minute
Interval -6.4 to 34.2
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 30
|
9.5 Liters per minute
Interval -16.2 to 35.3
|
17.2 Liters per minute
Interval -7.2 to 41.7
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 31
|
9.5 Liters per minute
Interval -11.9 to 31.0
|
11.5 Liters per minute
Interval -8.1 to 31.1
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 32
|
5.9 Liters per minute
Interval -18.7 to 30.5
|
17.2 Liters per minute
Interval -1.9 to 36.4
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 33
|
9.5 Liters per minute
Interval -15.2 to 34.3
|
7.3 Liters per minute
Interval -15.7 to 30.3
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 34
|
6.4 Liters per minute
Interval -22.3 to 35.3
|
6 Liters per minute
Interval -5.0 to 17.0
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 35
|
17.0 Liters per minute
Interval -6.0 to 40.1
|
7 Liters per minute
Interval -3.5 to 17.5
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 36
|
16.7 Liters per minute
Interval -4.2 to 37.7
|
3 Liters per minute
Interval -9.0 to 15.0
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 37
|
13.4 Liters per minute
Interval -8.4 to 35.2
|
9.2 Liters per minute
Interval -1.9 to 20.4
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 38
|
12.6 Liters per minute
Interval -7.4 to 32.6
|
5.5 Liters per minute
Interval -5.9 to 16.9
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 39
|
13.4 Liters per minute
Interval -8.1 to 35.0
|
9.5 Liters per minute
Interval -6.4 to 25.4
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 40
|
13.7 Liters per minute
Interval -8.6 to 36.0
|
10 Liters per minute
Interval -5.1 to 25.1
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 41
|
16.7 Liters per minute
Interval -10.1 to 43.6
|
8 Liters per minute
Interval -7.6 to 23.6
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 42
|
16.7 Liters per minute
Interval -8.2 to 41.7
|
10.2 Liters per minute
Interval -6.3 to 26.8
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 43
|
16.4 Liters per minute
Interval -5.8 to 38.8
|
15 Liters per minute
Interval -1.0 to 31.0
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 44
|
12.6 Liters per minute
Interval -14.2 to 39.4
|
9.5 Liters per minute
Interval -5.33 to 24.3
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 45
|
14.5 Liters per minute
Interval -7.0 to 36.1
|
7.5 Liters per minute
Interval -5.8 to 20.8
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 46
|
9.7 Liters per minute
Interval -8.8 to 28.2
|
5 Liters per minute
Interval -9.2 to 19.2
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 47
|
12.3 Liters per minute
Interval -6.4 to 31.1
|
7.2 Liters per minute
Interval -6.9 to 21.4
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 48
|
13.4 Liters per minute
Interval -13.1 to 40.0
|
6.2 Liters per minute
Interval -9.7 to 22.2
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 49
|
14.5 Liters per minute
Interval -11.1 to 40.2
|
12.8 Liters per minute
Interval -3.3 to 28.9
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 50
|
20.1 Liters per minute
Interval -0.5 to 40.7
|
9.7 Liters per minute
Interval -7.5 to 27.0
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 51
|
18.9 Liters per minute
Interval -4.8 to 42.7
|
13.2 Liters per minute
Interval -6.9 to 33.4
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 52
|
14.5 Liters per minute
Interval -7.3 to 36.4
|
21.5 Liters per minute
Interval 0.1 to 43.0
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 53
|
8.9 Liters per minute
Interval -11.9 to 29.9
|
17.3 Liters per minute
Interval -4.6 to 39.3
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 54
|
10.6 Liters per minute
Interval -10.8 to 32.1
|
14.4 Liters per minute
Interval -4.3 to 33.2
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 55
|
21.0 Liters per minute
Interval -14.4 to 56.6
|
18.7 Liters per minute
Interval -5.4 to 43.0
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 56
|
12.5 Liters per minute
Interval -11.1 to 36.2
|
26.5 Liters per minute
Interval -0.3 to 53.4
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 57
|
16.2 Liters per minute
Interval -6.8 to 39.3
|
32.3 Liters per minute
Interval 5.9 to 58.7
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 58
|
14.2 Liters per minute
Interval -9.3 to 37.8
|
10.4 Liters per minute
Interval -7.2 to 28.1
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 59
|
15.1 Liters per minute
Interval -7.9 to 38.1
|
11.2 Liters per minute
Interval -2.84 to 25.3
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 60
|
16.4 Liters per minute
Interval -12.5 to 45.5
|
1.2 Liters per minute
Interval -11.1 to 13.6
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 61
|
18.9 Liters per minute
Interval -1.9 to 39.9
|
5.7 Liters per minute
Interval -9.0 to 20.5
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 62
|
16.9 Liters per minute
Interval -6.5 to 40.4
|
10.2 Liters per minute
Interval -6.6 to 27.1
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 63
|
22.4 Liters per minute
Interval -2.7 to 47.6
|
7.2 Liters per minute
Interval -8.6 to 23.1
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 64
|
7.9 Liters per minute
Interval -16.0 to 31.9
|
9.5 Liters per minute
Interval -5.9 to 24.9
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 65
|
12.9 Liters per minute
Interval -4.9 to 30.9
|
15 Liters per minute
Interval -3.7 to 33.7
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 66
|
10.0 Liters per minute
Interval -9.2 to 29.4
|
10 Liters per minute
Interval -5.3 to 25.3
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 67
|
12.7 Liters per minute
Interval -7.2 to 32.7
|
15.2 Liters per minute
Interval -4.4 to 34.9
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 68
|
14.3 Liters per minute
Interval -5.0 to 33.6
|
11 Liters per minute
Interval -4.02 to 26.0
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 69
|
11.9 Liters per minute
Interval -5.6 to 29.5
|
11.5 Liters per minute
Interval -6.0 to 29.0
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 70
|
10.8 Liters per minute
Interval -6.4 to 28.2
|
11.2 Liters per minute
Interval -4.0 to 26.5
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 71
|
7.9 Liters per minute
Interval -11.0 to 26.9
|
11 Liters per minute
Interval -5.31 to 27.3
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 72
|
7.9 Liters per minute
Interval -11.3 to 27.2
|
14.9 Liters per minute
Interval -0.3 to 30.1
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 73
|
3.2 Liters per minute
Interval -8.2 to 14.7
|
14.3 Liters per minute
Interval -5.3 to 34.0
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 74
|
6.2 Liters per minute
Interval -10.0 to 22.6
|
10.7 Liters per minute
Interval -6.7 to 28.2
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 75
|
7.13 Liters per minute
Interval -10.3 to 24.6
|
13 Liters per minute
Interval -7.4 to 33.4
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 76
|
12.1 Liters per minute
Interval -6.4 to 30.7
|
11.2 Liters per minute
Interval -8.2 to 30.7
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 77
|
12.3 Liters per minute
Interval -15.6 to 40.2
|
16.5 Liters per minute
Interval -5.1 to 38.1
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 78
|
10.4 Liters per minute
Interval -9.9 to 30.8
|
12 Liters per minute
Interval -4.2 to 28.2
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 79
|
21.2 Liters per minute
Interval -5.9 to 48.4
|
9.7 Liters per minute
Interval -10.3 to 29.8
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 80
|
18.1 Liters per minute
Interval -7.1 to 43.3
|
10 Liters per minute
Interval -8.0 to 28.0
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 81
|
7.3 Liters per minute
Interval -8.6 to 23.2
|
7 Liters per minute
Interval -11.0 to 25.0
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 82
|
5.6 Liters per minute
Interval -11.5 to 22.8
|
10 Liters per minute
Interval -7.2 to 27.2
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 83
|
21.1 Liters per minute
Interval -7.7 to 49.9
|
13.0 Liters per minute
Interval -5.7 to 31.8
|
—
|
—
|
|
Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Day 84
|
12.9 Liters per minute
Interval -14.9 to 40.9
|
11.6 Liters per minute
Interval -19.7 to 43.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 1 to 4; Weeks 5 to 8 and Weeks 9 to 12Population: All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
For reliever/rescue use, bronchodilator use recorded in the diary was summarized as the mean number of occasions of rescue use per day.where a rescue-free day was defined as a 24-hour period in which the number of occasions of bronchodilator use was zero. Number of occasions bronchodilator taken in the last 24 hours were collected in the daily diary. The mean number of occasions of rescue use per day, were calculated for each participant during the four weekly periods (Weeks 1 to 4; Weeks 5-8 and Weeks 9-12). The study had a protocol amendment to reflect changes in manufacturing device from DISKUS to ELLIPTA after study had been initiated, but the 2 treatment arms remained the same i.e. Placebo and NEMI.There was no intent to compare two devices.
Outcome measures
| Measure |
All NEMI
n=22 Participants
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
All NEMI
n=22 Participants
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
Placebo Via ELLIPTA
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
NEMI 700 mcg Via ELLIPTA
Participants were administered with NEMI 700 mcg once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
|---|---|---|---|---|
|
Mean Number of Occasions of Rescue Usage Per Day
Weeks 1-4,n=22,21
|
3.05 Rescue use per day
Standard Deviation 2.520
|
2.77 Rescue use per day
Standard Deviation 2.432
|
—
|
—
|
|
Mean Number of Occasions of Rescue Usage Per Day
Weeks 5-8,n=19,20
|
2.93 Rescue use per day
Standard Deviation 2.342
|
2.81 Rescue use per day
Standard Deviation 2.827
|
—
|
—
|
|
Mean Number of Occasions of Rescue Usage Per Day
Weeks 9-12,n=19,20
|
3.19 Rescue use per day
Standard Deviation 2.065
|
2.84 Rescue use per day
Standard Deviation 2.569
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 1 to 4; Weeks 5 to 8 and Weeks 9 to 12Population: All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
For reliever/rescue use, bronchodilator use recorded in the diary was summarized as the mean number of occasions of rescue use per day, where a rescue-free day was defined as a 24-hour period in which the number of occasions of bronchodilator use was zero. Number of occasions bronchodilator taken in the last 24 hours were collected in the daily diary. The mean number of rescue free days were calculated for each participant during the four weekly periods (Weeks 1 to 4; Weeks 5-8 and Weeks 9-12). The study had a protocol amendment to reflect changes in manufacturing device from DISKUS to ELLIPTA after study had been initiated, but the 2 treatment arms remained the same i.e. Placebo and NEMI. There was no intent to compare two devices.
Outcome measures
| Measure |
All NEMI
n=22 Participants
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
All NEMI
n=22 Participants
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
Placebo Via ELLIPTA
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
NEMI 700 mcg Via ELLIPTA
Participants were administered with NEMI 700 mcg once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
|---|---|---|---|---|
|
Mean Rescue Medication Free Days
Weeks 1-4,n=22,21
|
7.5 Days
Standard Deviation 9.21
|
7.7 Days
Standard Deviation 10.06
|
—
|
—
|
|
Mean Rescue Medication Free Days
Weeks 5-8,n=19,20
|
5.8 Days
Standard Deviation 8.58
|
9.0 Days
Standard Deviation 12.14
|
—
|
—
|
|
Mean Rescue Medication Free Days
Weeks 9-12,n=19,20
|
3.7 Days
Standard Deviation 6.68
|
7.9 Days
Standard Deviation 11.14
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Days 12, 28, 56, 84Population: All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
FEV1 is the volume of air that can forcibly be blown out in one second. A triplicate FEV1 measurement were taken daily in the morning before dose administration using the site's spirometer as soon as it was safe to do so. FVC is defined as the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. Baseline is the latest available measurement from Day 2 Within 48 hours /discharge (On Treatment) and Day 1 (Pre-Treatment). Change from Baseline is the post-Baseline value minus Baseline value. The study had a protocol amendment to reflect changes in manufacturing device from DISKUS to ELLIPTA after study had been initiated, but the 2 treatment arms remained the same i.e. Placebo and NEMI.There was no intent to compare two devices.
Outcome measures
| Measure |
All NEMI
n=22 Participants
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
All NEMI
n=22 Participants
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
Placebo Via ELLIPTA
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
NEMI 700 mcg Via ELLIPTA
Participants were administered with NEMI 700 mcg once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
|---|---|---|---|---|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC)
FVC,Day 28,n=19,20
|
0.024 Liters
Standard Deviation 0.4159
|
0.231 Liters
Standard Deviation 0.4270
|
—
|
—
|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC)
FEV1,Day 12,n=20,18
|
-0.001 Liters
Standard Deviation 0.1681
|
0.084 Liters
Standard Deviation 0.1879
|
—
|
—
|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC)
FEV1,Day 28,n=19,20
|
0.005 Liters
Standard Deviation 0.2227
|
0.094 Liters
Standard Deviation 0.2035
|
—
|
—
|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC)
FEV1,Day 56,n=19,20
|
-0.014 Liters
Standard Deviation 0.1783
|
0.112 Liters
Standard Deviation 0.2613
|
—
|
—
|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC)
FEV1,Day 84,n=17,20
|
-0.029 Liters
Standard Deviation 0.1281
|
0.077 Liters
Standard Deviation 0.2747
|
—
|
—
|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC)
FVC,Day 12,n=20,18
|
-0.024 Liters
Standard Deviation 0.4723
|
0.062 Liters
Standard Deviation 0.3770
|
—
|
—
|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC)
FVC,Day 56,n=19,20
|
-0.078 Liters
Standard Deviation 0.4106
|
0.212 Liters
Standard Deviation 0.4827
|
—
|
—
|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC)
FVC,Day 84,n=17,20
|
-0.104 Liters
Standard Deviation 0.3786
|
0.123 Liters
Standard Deviation 0.4579
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Screening) and up to 14 weeksPopulation: All Subjects Population.
Blood samples were collected to analyze the following s hematology parameters: Hemoglobin, Hematocrit, Mean Corpuscle Hemoglobin (MCH), Mean Corpuscle Volume (MCV), Platelet count, Red Blood Cell (RBC) count, White Blood Cell (WBC) count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils. Participants were counted in the worst case category that their value changes to (low or high), unless there is no change in their category. Participants whose lab value category was unchanged (example given \[e.g.\],High to High), or whose value became normal, were not recorded. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%. The value at Screening was considered as Baseline. Data for Worst Case Laboratory Hematology values Post-Baseline Relative to Baseline has been presented.
Outcome measures
| Measure |
All NEMI
n=14 Participants
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
All NEMI
n=14 Participants
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
Placebo Via ELLIPTA
n=8 Participants
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
NEMI 700 mcg Via ELLIPTA
n=8 Participants
Participants were administered with NEMI 700 mcg once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
|---|---|---|---|---|
|
Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline
MCV,To High
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline
Monocytes,To Low
|
2 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline
Monocytes,To High
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline
Total Neutrophils,To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline
Total Neutrophils,To High
|
4 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline
Platelet count,To Low
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline
Platelet count,To High
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline
RBC,To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline
RBC,To High
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline
WBC,To Low
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline
WBC,To High
|
4 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline
Basophils,To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline
Basophils,To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline
Eosinophils,To Low
|
2 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline
Eosinophils,To High
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline
Hemoglobin,To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline
Hemoglobin,To High
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline
Hematocrit,To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline
Hematocrit,To High
|
3 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline
Lymphocytes,To Low
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline
Lymphocytes,To High
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline
MCH,To Low
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline
MCH,To High
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline
MCV,To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Screening) and up to 14 weeksPopulation: All Subjects Population.
Blood samples were collected to analyze the following Chemistry parameters: Albumin, Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Direct Bilirubin, Total Bilirubin, Calcium, C-Reactive protein, Creatinine, Glucose, Potassium, Sodium, Total Protein and Urea/Blood urea nitrogen. Participants were counted in the worst case category that their value changes to (low, normal or high), unless there is no change in their category. Participants whose lab value category was unchanged e.g. High to High), or whose value became normal, were not recorded. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%. The value at Screening was considered as Baseline. Data for Worst Case Laboratory chemistry values Post-Baseline Relative to Baseline has been presented.
Outcome measures
| Measure |
All NEMI
n=14 Participants
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
All NEMI
n=14 Participants
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
Placebo Via ELLIPTA
n=8 Participants
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
NEMI 700 mcg Via ELLIPTA
n=8 Participants
Participants were administered with NEMI 700 mcg once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
|---|---|---|---|---|
|
Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline
Albumin,To Low
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline
Albumin,To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline
ALP,To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline
ALP,To High
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline
ALT,To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline
ALT,To High
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline
C-Reactive protein,To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline
C-Reactive protein,To High
|
4 Participants
|
5 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline
Creatinine,To Low
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline
Creatinine,To High
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline
Glucose,To Low
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline
Glucose,To High
|
3 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline
Potassium,To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline
Potassium,To High
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline
Sodium,To Low
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline
Urea/BUN,To Low
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline
Urea/BUN,To High
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline
Total Bilirubin,To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline
Total Bilirubin,To High
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline
Calcium,To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline
Calcium,To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline
Sodium,To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline
Total Protein,To Low
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline
Total Protein,To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline
AST,To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline
AST,To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline
Direct Bilirubin,To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline
Direct Bilirubin,To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Screening) and up to 14 weeksPopulation: All Subjects Population.
Vital signs were measured in semi-supine position after 5 minutes rest and included Systolic blood pressure (SBP), Diastolic blood pressure (DBP), Heart rate (HR). Data for number of participants with Post-Baseline worst case Vital Sign results relative to PCI Criteria relative to Baseline was presented. PCI ranges were: SBP (lower: \<85 and upper: \>160 mmHg), DBP (lower: \<45 and upper: \>100 mmHg), and HR (lower: \<40 and upper: \>110 bpm). The value at Screening was considered as Baseline.
Outcome measures
| Measure |
All NEMI
n=14 Participants
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
All NEMI
n=14 Participants
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
Placebo Via ELLIPTA
n=8 Participants
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
NEMI 700 mcg Via ELLIPTA
n=8 Participants
Participants were administered with NEMI 700 mcg once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
|---|---|---|---|---|
|
Number of Participants With Worst Case Vital Sign Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
SBP, To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Vital Sign Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
SBP, To High
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Worst Case Vital Sign Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
DBP, To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Vital Sign Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
HR, To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Vital Sign Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
HR, To High
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst Case Vital Sign Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
DBP, To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 14 weeksPopulation: All Subjects Population.
A Single 12-lead ECGs was obtained at screening and at each other timepoint during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT interval corrected using the Fridericia's formula (QTcF) intervals. Data for number of participants with worst case post-Baseline abnormal ECG findings was reported. The value at Screening was considered as Baseline.
Outcome measures
| Measure |
All NEMI
n=14 Participants
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
All NEMI
n=14 Participants
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
Placebo Via ELLIPTA
n=8 Participants
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
NEMI 700 mcg Via ELLIPTA
n=8 Participants
Participants were administered with NEMI 700 mcg once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
|---|---|---|---|---|
|
Number of Participants With Worst Case Post-Baseline Abnormal Electrocardiogram (ECG) Findings
Abnormal - not clinically significant
|
10 Participants
|
7 Participants
|
6 Participants
|
7 Participants
|
|
Number of Participants With Worst Case Post-Baseline Abnormal Electrocardiogram (ECG) Findings
Abnormal - clinically significant
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 14 weeksPopulation: All Subjects Population.
An AE is any untoward medical occurrence in a clinical investigation participant, or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward medical occurrence that at any dose, resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, is associated with liver injury and impaired liver function or any other situation according to medical or scientific judgment was categorized as SAE. Number of participants with AEs and SAEs have been reported.
Outcome measures
| Measure |
All NEMI
n=14 Participants
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
All NEMI
n=14 Participants
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
Placebo Via ELLIPTA
n=8 Participants
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
NEMI 700 mcg Via ELLIPTA
n=8 Participants
Participants were administered with NEMI 700 mcg once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
Any AE
|
11 Participants
|
11 Participants
|
5 Participants
|
5 Participants
|
|
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
Any SAE
|
2 Participants
|
3 Participants
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1: 5 minutes Post-dose on Day 1Population: Pharmacokinetic Population comprised of participants in all subject population for whom a pharmacokinetic sample was obtained and analyzed.
Blood samples for pharmacokinetic (PK) analysis was collected at the indicated time points following administration of NEMI via DISKUS and ELLIPTA.
Outcome measures
| Measure |
All NEMI
n=14 Participants
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
All NEMI
n=7 Participants
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
Placebo Via ELLIPTA
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
NEMI 700 mcg Via ELLIPTA
Participants were administered with NEMI 700 mcg once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) Following Administration of NEMI
|
508.4 Picograms per milliliter
Geometric Coefficient of Variation 69
|
1103.4 Picograms per milliliter
Geometric Coefficient of Variation 34
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: 24 Hours post-dose; Days 12, 28, 56, 84: Pre-dosePopulation: Pharmacokinetic Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
Blood samples for pharmacokinetic (PK) analysis was collected at the indicated time points following administration of NEMI via DISKUS and ELLIPTA.
Outcome measures
| Measure |
All NEMI
n=14 Participants
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
All NEMI
n=8 Participants
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
|
Placebo Via ELLIPTA
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
NEMI 700 mcg Via ELLIPTA
Participants were administered with NEMI 700 mcg once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
|---|---|---|---|---|
|
Trough Concentration Following Administration of NEMI
Day 28,pre-dose, n=9,7
|
1194.3 Picograms per milliliter
Geometric Coefficient of Variation 76
|
1225.8 Picograms per milliliter
Geometric Coefficient of Variation 50
|
—
|
—
|
|
Trough Concentration Following Administration of NEMI
Day 56,pre-dose,n=11,7
|
1155.1 Picograms per milliliter
Geometric Coefficient of Variation 60
|
1171.6 Picograms per milliliter
Geometric Coefficient of Variation 49
|
—
|
—
|
|
Trough Concentration Following Administration of NEMI
Day 84,pre-dose,n=11,7
|
1339.6 Picograms per milliliter
Geometric Coefficient of Variation 53
|
1058.2 Picograms per milliliter
Geometric Coefficient of Variation 33
|
—
|
—
|
|
Trough Concentration Following Administration of NEMI
Day 1,24 hour, n=8,2
|
313.9 Picograms per milliliter
Geometric Coefficient of Variation 61
|
NA Picograms per milliliter
Geometric Coefficient of Variation NA
Full summary statistics are only calculated if there are 3 or more quantifiable values. There were only 2 evaluable participants in this arm for this time point and therefore data was not available.
|
—
|
—
|
|
Trough Concentration Following Administration of NEMI
Day 12,pre-dose,n=9,5
|
1097.1 Picograms per milliliter
Geometric Coefficient of Variation 38
|
1077.2 Picograms per milliliter
Geometric Coefficient of Variation 23
|
—
|
—
|
Adverse Events
Placebo Via DISKUS
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
NEMI 1000 mcg Via DISKUS
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo Via ELLIPTA
Serious events: 4 serious events
Other events: 5 other events
Deaths: 0 deaths
NEMI 700 mcg Via ELLIPTA
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Via DISKUS
n=14 participants at risk
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using DISKUS DPI
|
NEMI 1000 mcg Via DISKUS
n=14 participants at risk
Participants were administered with NEMI 1000 mcg once daily in the morning before breakfast for 84 consecutive days using DISKUS DPI.
|
Placebo Via ELLIPTA
n=8 participants at risk
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI
|
NEMI 700 mcg Via ELLIPTA
n=8 participants at risk
Participants were administered with NEMI 700 mcg once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
14.3%
2/14 • Number of events 2 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
12.5%
1/8 • Number of events 2 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
7.1%
1/14 • Number of events 1 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
7.1%
1/14 • Number of events 1 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
12.5%
1/8 • Number of events 1 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
7.1%
1/14 • Number of events 1 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
25.0%
2/8 • Number of events 2 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
12.5%
1/8 • Number of events 1 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
7.1%
1/14 • Number of events 1 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
1/14 • Number of events 1 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
12.5%
1/8 • Number of events 1 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
12.5%
1/8 • Number of events 1 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
Other adverse events
| Measure |
Placebo Via DISKUS
n=14 participants at risk
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using DISKUS DPI
|
NEMI 1000 mcg Via DISKUS
n=14 participants at risk
Participants were administered with NEMI 1000 mcg once daily in the morning before breakfast for 84 consecutive days using DISKUS DPI.
|
Placebo Via ELLIPTA
n=8 participants at risk
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI
|
NEMI 700 mcg Via ELLIPTA
n=8 participants at risk
Participants were administered with NEMI 700 mcg once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
14.3%
2/14 • Number of events 2 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
12.5%
1/8 • Number of events 2 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.1%
1/14 • Number of events 1 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
7.1%
1/14 • Number of events 1 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
12.5%
1/8 • Number of events 1 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
7.1%
1/14 • Number of events 1 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
12.5%
1/8 • Number of events 1 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
7.1%
1/14 • Number of events 1 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.1%
1/14 • Number of events 1 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
12.5%
1/8 • Number of events 1 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.1%
1/14 • Number of events 1 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
7.1%
1/14 • Number of events 1 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
7.1%
1/14 • Number of events 1 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
25.0%
2/8 • Number of events 2 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
14.3%
2/14 • Number of events 2 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
21.4%
3/14 • Number of events 3 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
7.1%
1/14 • Number of events 2 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
12.5%
1/8 • Number of events 1 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
7.1%
1/14 • Number of events 1 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
7.1%
1/14 • Number of events 1 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
|
Gastrointestinal disorders
Diarrhoea
|
21.4%
3/14 • Number of events 3 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
14.3%
2/14 • Number of events 2 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
12.5%
1/8 • Number of events 1 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
|
Infections and infestations
Nasopharyngitis
|
7.1%
1/14 • Number of events 1 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
7.1%
1/14 • Number of events 1 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
12.5%
1/8 • Number of events 1 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
25.0%
2/8 • Number of events 2 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
|
Infections and infestations
Oral herpes
|
7.1%
1/14 • Number of events 1 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
12.5%
1/8 • Number of events 1 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
12.5%
1/8 • Number of events 1 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
|
Infections and infestations
Periorbital cellulitis
|
7.1%
1/14 • Number of events 1 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
7.1%
1/14 • Number of events 1 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
7.1%
1/14 • Number of events 1 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
1/14 • Number of events 1 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
7.1%
1/14 • Number of events 1 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
12.5%
1/8 • Number of events 1 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
14.3%
2/14 • Number of events 2 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
7.1%
1/14 • Number of events 1 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.3%
2/14 • Number of events 4 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
7.1%
1/14 • Number of events 1 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
7.1%
1/14 • Number of events 1 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
|
Nervous system disorders
Headache
|
7.1%
1/14 • Number of events 1 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
28.6%
4/14 • Number of events 10 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
12.5%
1/8 • Number of events 1 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
|
Nervous system disorders
Aphonia
|
7.1%
1/14 • Number of events 1 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
7.1%
1/14 • Number of events 1 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
|
General disorders
Chest pain
|
14.3%
2/14 • Number of events 4 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
|
General disorders
Chills
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
7.1%
1/14 • Number of events 1 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
|
General disorders
Drug intolerance
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
7.1%
1/14 • Number of events 1 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
|
General disorders
Pyrexia
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
7.1%
1/14 • Number of events 1 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
7.1%
1/14 • Number of events 1 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
12.5%
1/8 • Number of events 1 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
25.0%
2/8 • Number of events 2 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
12.5%
1/8 • Number of events 1 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
12.5%
1/8 • Number of events 1 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
12.5%
1/8 • Number of events 1 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
12.5%
1/8 • Number of events 1 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
|
Psychiatric disorders
Anxiety disorder
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
12.5%
1/8 • Number of events 1 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
|
Psychiatric disorders
Depressive symptom
|
7.1%
1/14 • Number of events 1 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
12.5%
1/8 • Number of events 1 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
|
Psychiatric disorders
Panic attack
|
7.1%
1/14 • Number of events 1 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
7.1%
1/14 • Number of events 1 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
7.1%
1/14 • Number of events 1 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
12.5%
1/8 • Number of events 1 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
7.1%
1/14 • Number of events 1 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
|
Immune system disorders
Seasonal allergy
|
7.1%
1/14 • Number of events 1 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
12.5%
1/8 • Number of events 1 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
12.5%
1/8 • Number of events 1 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
1/14 • Number of events 1 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/14 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
0.00%
0/8 • Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
All Subjects Population was used to collect Adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER