Trial Outcomes & Findings for Evaluation of Umeclidinium Bromide in Combination With Fluticasone Furoate in COPD Subjects With an Asthmatic Component (NCT NCT02164539)
NCT ID: NCT02164539
Last Updated: 2017-10-11
Results Overview
FEV1 is defined as forced expiratory volume in one second and measured in the morning at Visits 1 through 8 between 6:00 and 11:00 electronically by spirometry. Change from Baseline in trough FEV1 is defined as the difference in the value obtained at Visit 6 (24 hours post-dose on Visit 5) and the last acceptable/borderline acceptable value obtained prior to randomization (from Visit 2 pre-bronchodilator or Visit 3 pre-dose). Trough FEV1 is defined as the acceptable/borderline acceptable FEV1 value obtained at Visit 6, approximately 24 hours after morning dosing on Visit 5. ITT population is comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. All comparisons for statistical purposes are with the FF 100 µg arm.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
338 participants
Primary outcome timeframe
Baseline and Day 29
Results posted on
2017-10-11
Participant Flow
Participants (par.) with sufficient signs and symptoms to diagnose as having chronic obstructive pulmonary disease (COPD) and evidence of an asthmatic component as demonstrated by spirometry, reversibility and current therapy at the point of screening were eligible for participation in the study.
Participants on inhaled corticosteroid therapy over the previous 12 weeks, including a stable dose during the 4 weeks prior to Visit 0, entered the 4-week run-in period on open-label fluticasone propionate 250 microgram (µg) and salmeterol 50 µg combination. Eligible par. were stratified by smoking status, age and randomized to Treatment Phase A.
Participant milestones
| Measure |
FF/VI 100/25 µg
Participants received FF 100 µg in combination with vilanterol trifenatate (VI) 25 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A and 1 week during Treatment Phase C. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
|
FF/UMEC/VI 100/250/25 µg
Participants received FF 100 µg in combination with umeclidinium bromide (UMEC) 250 µg and VI 25 µg once daily in the morning by inhalation using two separate DPIs (FF/UMEC 100/250 \& VI 25) for 1 week during Treatment Phase B and C. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
|
FF 100 µg
Participants received fluticasone furoate (FF) 100 µg once daily in the morning by inhalation using a dry powder inhaler (DPI) for 4 weeks during Treatment Phase A and 1 week during Treatment Phase C. In addition, all participants received supplemental albuterol/salbutamol via metered-dose inhaler (MDI) to be used on an as-needed basis (rescue medication) throughout the study.
|
FF/UMEC 100/15.6 µg
Participants received FF 100 µg in combination with umeclidinium bromide (UMEC) 15.6 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
|
FF/UMEC 100/62.5 µg
Participants received FF 100 µg in combination with UMEC 62.5 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
|
FF/UMEC 100/125 µg
Participants received FF 100 µg in combination with UMEC 125 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
|
FF/UMEC 100/250 µg
Participants received FF 100 µg in combination with UMEC 250 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A and 1 week during Treatment Phase B and C. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
|
|---|---|---|---|---|---|---|---|
|
Treatment Phase A (4 Weeks)
STARTED
|
84
|
0
|
41
|
42
|
40
|
46
|
85
|
|
Treatment Phase A (4 Weeks)
COMPLETED
|
83
|
0
|
39
|
42
|
39
|
44
|
82
|
|
Treatment Phase A (4 Weeks)
NOT COMPLETED
|
1
|
0
|
2
|
0
|
1
|
2
|
3
|
|
Treatment Phase B (1 Week)
STARTED
|
0
|
163
|
0
|
0
|
0
|
0
|
166
|
|
Treatment Phase B (1 Week)
COMPLETED
|
0
|
162
|
0
|
0
|
0
|
0
|
163
|
|
Treatment Phase B (1 Week)
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
3
|
|
Treatment Phase C (1 Week)
STARTED
|
82
|
80
|
79
|
0
|
0
|
0
|
84
|
|
Treatment Phase C (1 Week)
COMPLETED
|
82
|
78
|
78
|
0
|
0
|
0
|
84
|
|
Treatment Phase C (1 Week)
NOT COMPLETED
|
0
|
2
|
1
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
FF/VI 100/25 µg
Participants received FF 100 µg in combination with vilanterol trifenatate (VI) 25 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A and 1 week during Treatment Phase C. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
|
FF/UMEC/VI 100/250/25 µg
Participants received FF 100 µg in combination with umeclidinium bromide (UMEC) 250 µg and VI 25 µg once daily in the morning by inhalation using two separate DPIs (FF/UMEC 100/250 \& VI 25) for 1 week during Treatment Phase B and C. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
|
FF 100 µg
Participants received fluticasone furoate (FF) 100 µg once daily in the morning by inhalation using a dry powder inhaler (DPI) for 4 weeks during Treatment Phase A and 1 week during Treatment Phase C. In addition, all participants received supplemental albuterol/salbutamol via metered-dose inhaler (MDI) to be used on an as-needed basis (rescue medication) throughout the study.
|
FF/UMEC 100/15.6 µg
Participants received FF 100 µg in combination with umeclidinium bromide (UMEC) 15.6 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
|
FF/UMEC 100/62.5 µg
Participants received FF 100 µg in combination with UMEC 62.5 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
|
FF/UMEC 100/125 µg
Participants received FF 100 µg in combination with UMEC 125 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
|
FF/UMEC 100/250 µg
Participants received FF 100 µg in combination with UMEC 250 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A and 1 week during Treatment Phase B and C. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
|
|---|---|---|---|---|---|---|---|
|
Treatment Phase A (4 Weeks)
Withdrawal by Subject
|
1
|
0
|
2
|
0
|
1
|
2
|
3
|
|
Treatment Phase B (1 Week)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Treatment Phase B (1 Week)
Physician Decision
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
|
Treatment Phase C (1 Week)
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Treatment Phase C (1 Week)
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Phase C (1 Week)
Physician Decision
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Evaluation of Umeclidinium Bromide in Combination With Fluticasone Furoate in COPD Subjects With an Asthmatic Component
Baseline characteristics by cohort
| Measure |
FF 100 µg
n=41 Participants
Participants received FF 100 µg once daily in the morning by inhalation using a DPI for 4 weeks in Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
|
FF/UMEC 100/15.6 µg
n=42 Participants
Participants received FF 100 µg in combination with UMEC 15.6 µg once daily in the morning by inhalation using a DPI for 4 weeks in Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
|
FF/UMEC 100/62.5 µg
n=40 Participants
Participants received FF 100 µg in combination with UMEC 62.5 µg once daily in the morning by inhalation using a DPI for 4 weeks in Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
|
FF/UMEC 100/125 µg
n=46 Participants
Participants received FF 100 µg in combination with UMEC 125 µg once daily in the morning by inhalation using a DPI for 4 weeks in Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
|
FF/UMEC 100/250 µg
n=85 Participants
Participants received FF 100 µg in combination with UMEC 250 µg once daily in the morning by inhalation using a DPI for 4 weeks in Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
|
FF/VI 100/25 µg
n=84 Participants
Participants received FF 100 µg in combination with VI 25 µg once daily in the morning by inhalation using a DPI for 4 weeks in Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
|
Total
n=338 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
58.4 Years
STANDARD_DEVIATION 8.59 • n=5 Participants
|
55.5 Years
STANDARD_DEVIATION 11.33 • n=7 Participants
|
56.7 Years
STANDARD_DEVIATION 10.14 • n=5 Participants
|
58.2 Years
STANDARD_DEVIATION 10.47 • n=4 Participants
|
57.8 Years
STANDARD_DEVIATION 11.03 • n=21 Participants
|
57.6 Years
STANDARD_DEVIATION 10.95 • n=10 Participants
|
57.5 Years
STANDARD_DEVIATION 10.56 • n=115 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
41 Participants
n=10 Participants
|
160 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
43 Participants
n=10 Participants
|
178 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
White- Arabic/ North African Heritage
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
White- White/Caucasian/European Heritage
|
40 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
81 Participants
n=21 Participants
|
83 Participants
n=10 Participants
|
329 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Mixed Race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 29Population: ITT Population. Only those participants available at the specified time point were analyzed.
FEV1 is defined as forced expiratory volume in one second and measured in the morning at Visits 1 through 8 between 6:00 and 11:00 electronically by spirometry. Change from Baseline in trough FEV1 is defined as the difference in the value obtained at Visit 6 (24 hours post-dose on Visit 5) and the last acceptable/borderline acceptable value obtained prior to randomization (from Visit 2 pre-bronchodilator or Visit 3 pre-dose). Trough FEV1 is defined as the acceptable/borderline acceptable FEV1 value obtained at Visit 6, approximately 24 hours after morning dosing on Visit 5. ITT population is comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. All comparisons for statistical purposes are with the FF 100 µg arm.
Outcome measures
| Measure |
FF 100 µg
n=39 Participants
Participants received fluticasone furoate (FF) 100 µg once daily in the morning by inhalation using a dry powder inhaler (DPI) for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via metered-dose inhaler (MDI) to be used on an as-needed basis (rescue medication) throughout the study.
|
FF/UMEC 100/15.6 µg
n=42 Participants
Participants received FF 100 µg in combination with umeclidinium bromide (UMEC) 15.6 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
|
FF/UMEC 100/62.5 µg
n=39 Participants
Participants received FF 100 µg in combination with UMEC 62.5 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
|
FF/UMEC 100/125 µg
n=44 Participants
Participants received FF 100 µg in combination with UMEC 125 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
|
FF/UMEC 100/250 µg
n=81 Participants
Participants received FF 100 µg in combination with UMEC 250 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
|
FF/VI 100/25 µg
n=83 Participants
Participants received FF 100 µg in combination with vilanterol trifenatate (VI) 25 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Clinic Trough Forced Expiratory Volume in One Second (FEV1) at the End of Treatment Phase A (Visit 6/Day 29)
|
0.047 Liters
Standard Deviation 0.3002
|
0.146 Liters
Standard Deviation 0.2330
|
0.193 Liters
Standard Deviation 0.2192
|
0.175 Liters
Standard Deviation 0.2478
|
0.143 Liters
Standard Deviation 0.3150
|
0.121 Liters
Standard Deviation 0.2779
|
SECONDARY outcome
Timeframe: Baseline and End of Treatment Phase A (The end of Treatment Phase A was defined as the last 7 days of Treatment Phase A, including the AM assessments on the date of Visit 6)Population: ITT Population. Only those participants available at the specified time point were analyzed.
All participants received the albuterol/salbutamol via MDI as a rescue medication on an as-needed basis. Total daily rescue medication use for a given day is the sum of daytime albuterol/salbutamol use recorded in PM and nighttime albuterol/salbutamol use recorded in AM the next day. The number of puffs of albuterol (salbutamol) MDI used in the last 12 hours for relief of symptoms were recorded morning and evening in the eDiary by the participants. End of Treatment Phase A is the last 7 days of Treatment Phase A. Change from Baseline at the end of Treatment Phase is the difference between the end of Treatment Phase value and the appropriate baseline week. Analysis performed using analysis of covariance with covariates of treatment, age, sex, baseline rescue medication use, pack years smoked per randomization stratification and age when first treated with an inhaler per randomization stratification. Baseline is the last 7 days of the run-in period prior to randomization
Outcome measures
| Measure |
FF 100 µg
n=41 Participants
Participants received fluticasone furoate (FF) 100 µg once daily in the morning by inhalation using a dry powder inhaler (DPI) for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via metered-dose inhaler (MDI) to be used on an as-needed basis (rescue medication) throughout the study.
|
FF/UMEC 100/15.6 µg
n=42 Participants
Participants received FF 100 µg in combination with umeclidinium bromide (UMEC) 15.6 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
|
FF/UMEC 100/62.5 µg
n=40 Participants
Participants received FF 100 µg in combination with UMEC 62.5 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
|
FF/UMEC 100/125 µg
n=46 Participants
Participants received FF 100 µg in combination with UMEC 125 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
|
FF/UMEC 100/250 µg
n=85 Participants
Participants received FF 100 µg in combination with UMEC 250 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
|
FF/VI 100/25 µg
n=84 Participants
Participants received FF 100 µg in combination with vilanterol trifenatate (VI) 25 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
|
|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Rescue Medication Use at the End of Treatment Phase A
|
0.6 Puffs
Standard Error 0.29
|
-0.4 Puffs
Standard Error 0.29
|
-0.5 Puffs
Standard Error 0.29
|
0.0 Puffs
Standard Error 0.27
|
-0.2 Puffs
Standard Error 0.21
|
-0.1 Puffs
Standard Error 0.21
|
SECONDARY outcome
Timeframe: Baseline and End of Treatment Phase A (The end of Treatment Phase A was defined as the last 7 days of Treatment Phase A, including the AM assessments on the date of Visit 6)Population: ITT Population. Only those participants available at the specified time point were analyzed.
A daily symptoms score for exacerbations of chronic pulmonary disease tool - Respiratory Symptoms (E-RS) is derived by summing the 11 item-level E-RS scores and has a theoretical range of 0-40, with higher values indicating more severe respiratory symptoms. The Baseline E-RS score is defined as the mean within-subject daily score over the 7 days prior to randomization, with data present for a minimum of 4 of the 7 days. Change from Baseline at the end of Treatment Phase is the difference between the end of Treatment Phase value and the appropriate Baseline week. Analysis performed using analysis of covariance with covariates of treatment, age, sex, baseline score, pack years smoked per randomization stratification and age when first treated with an inhaler per randomization stratification. Baseline is the last 7 days of the run-in period prior to randomization. All comparisons for statistical purposes are with the FF 100 µg arm.
Outcome measures
| Measure |
FF 100 µg
n=39 Participants
Participants received fluticasone furoate (FF) 100 µg once daily in the morning by inhalation using a dry powder inhaler (DPI) for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via metered-dose inhaler (MDI) to be used on an as-needed basis (rescue medication) throughout the study.
|
FF/UMEC 100/15.6 µg
n=42 Participants
Participants received FF 100 µg in combination with umeclidinium bromide (UMEC) 15.6 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
|
FF/UMEC 100/62.5 µg
n=39 Participants
Participants received FF 100 µg in combination with UMEC 62.5 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
|
FF/UMEC 100/125 µg
n=43 Participants
Participants received FF 100 µg in combination with UMEC 125 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
|
FF/UMEC 100/250 µg
n=81 Participants
Participants received FF 100 µg in combination with UMEC 250 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
|
FF/VI 100/25 µg
n=83 Participants
Participants received FF 100 µg in combination with vilanterol trifenatate (VI) 25 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
|
|---|---|---|---|---|---|---|
|
Mean Change From Baseline in E-RS Total Scores at the End of Treatment Phase A
|
0.5 Score on scale
Standard Error 0.54
|
-2.6 Score on scale
Standard Error 0.55
|
-2.5 Score on scale
Standard Error 0.56
|
-1.5 Score on scale
Standard Error 0.52
|
-1.5 Score on scale
Standard Error 0.40
|
-1.1 Score on scale
Standard Error 0.41
|
SECONDARY outcome
Timeframe: Baseline and from Day 8 through Day 29Population: ITT Population. Only those participants available at the specified time point were analyzed.
Peak expiratory flow (PEF) stability limit was calculated from AM PEF measurements on the 7 days preceding Visit 3 as mean AM PEF from the available 7 days preceding Visit 3 x 80%. PEF stability limit serves as a benchmark of the participants run-in COPD status and used for comparison during the treatment phase to assess subject safety. Change from Baseline over the last 21 days of Treatment Phase A is the difference between the last 21 days of Treatment Phase A and the appropriate Baseline week. The last 21 days of Treatment Phase A include the AM assessments on the date of Visit 6. AM assessments include the date of Visit 6 and the 20 consecutive days preceding the date of Visit. Analysis performed using analysis of covariance with covariates of treatment, age, sex, Baseline AM PEF, pack years smoked per randomization stratification and age when first treated with an inhaler per randomization stratification. Baseline is the last 7 days of the run-in period prior to randomization
Outcome measures
| Measure |
FF 100 µg
n=39 Participants
Participants received fluticasone furoate (FF) 100 µg once daily in the morning by inhalation using a dry powder inhaler (DPI) for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via metered-dose inhaler (MDI) to be used on an as-needed basis (rescue medication) throughout the study.
|
FF/UMEC 100/15.6 µg
n=42 Participants
Participants received FF 100 µg in combination with umeclidinium bromide (UMEC) 15.6 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
|
FF/UMEC 100/62.5 µg
n=39 Participants
Participants received FF 100 µg in combination with UMEC 62.5 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
|
FF/UMEC 100/125 µg
n=43 Participants
Participants received FF 100 µg in combination with UMEC 125 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
|
FF/UMEC 100/250 µg
n=81 Participants
Participants received FF 100 µg in combination with UMEC 250 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
|
FF/VI 100/25 µg
n=83 Participants
Participants received FF 100 µg in combination with vilanterol trifenatate (VI) 25 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Daily Morning (AM) PEF (Pre-dose and Pre-rescue Bronchodilator) Measured at Home and Averaged Over the Last 21 Days of Treatment Phase A
|
-14.2 Liters per minute (L/min)
Standard Error 4.62
|
3.9 Liters per minute (L/min)
Standard Error 4.70
|
7.6 Liters per minute (L/min)
Standard Error 4.76
|
5.5 Liters per minute (L/min)
Standard Error 4.40
|
10.5 Liters per minute (L/min)
Standard Error 3.37
|
4.3 Liters per minute (L/min)
Standard Error 3.47
|
SECONDARY outcome
Timeframe: Baseline and Day 28Population: ITT Population. Only those participants available at the specified time point were analyzed.
FEV1 was measured in the morning by spirometry. At Visit 5, after trough FEV1 is measured, subject received investigational product. 3 hours post-dose, spirometry was repeated and subject then received 2 puffs of albuterol/salbutamol. After 30 minutes,spirometry was repeated.. Change from Baseline in clinic trough (pre-dose) FEV1 is the difference in the trough value at 3 hours post-dose peak FEV1 and the Baseline value. If the trough value or the Baseline was missing, then change from Baseline was considered as missing. Baseline value of clinic FEV1 is the last acceptable/borderline acceptable (pre-dose) FEV1 value obtained prior to randomization (from Visit 3 pre-dose or from Visit 2 pre-bronchodilator). Analysis done using analysis of covariance with covariates of treatment, age, sex, baseline clinic trough FEV1, pre-dose trough FEV1 at Visit 5, pack years smoked per randomization stratification and age when first treated with an inhaler per randomization stratification.
Outcome measures
| Measure |
FF 100 µg
n=38 Participants
Participants received fluticasone furoate (FF) 100 µg once daily in the morning by inhalation using a dry powder inhaler (DPI) for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via metered-dose inhaler (MDI) to be used on an as-needed basis (rescue medication) throughout the study.
|
FF/UMEC 100/15.6 µg
n=42 Participants
Participants received FF 100 µg in combination with umeclidinium bromide (UMEC) 15.6 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
|
FF/UMEC 100/62.5 µg
n=39 Participants
Participants received FF 100 µg in combination with UMEC 62.5 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
|
FF/UMEC 100/125 µg
n=45 Participants
Participants received FF 100 µg in combination with UMEC 125 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
|
FF/UMEC 100/250 µg
n=81 Participants
Participants received FF 100 µg in combination with UMEC 250 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
|
FF/VI 100/25 µg
n=82 Participants
Participants received FF 100 µg in combination with vilanterol trifenatate (VI) 25 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
|
|---|---|---|---|---|---|---|
|
Change From Trough in Clinic Forced Expiratory Volume (FEV1) at 3 Hours Post-study Treatment at Visit 5/Day 28
|
0.048 Liters (L)
Standard Error 0.0307
|
0.093 Liters (L)
Standard Error 0.0305
|
0.088 Liters (L)
Standard Error 0.0309
|
0.072 Liters (L)
Standard Error 0.0279
|
0.052 Liters (L)
Standard Error 0.0220
|
0.124 Liters (L)
Standard Error 0.0227
|
SECONDARY outcome
Timeframe: Baseline and Day 28Population: ITT Population. Only those participants available at the specified time point were analyzed.
FEV1 is defined as forced expiratory volume in one second and measured in the morning at Visits 1 through 8 between 6:00 and 11:00 electronically by spirometry. Reversibility was measured at Visit 1 and Visit 2 for study eligibility by change in clinic FEV1 within 20 to 60 minutes following 4 inhalations of albuterol/salbutamol and again measured 3 hours after dosing at Visit 5 by change in clinic FEV1 30 minutes following 2 inhalations of albuterol/salbutamol. Baseline value of clinic FEV1 is the last acceptable/borderline acceptable (pre-dose) FEV1 value obtained prior to randomization (either from Visit 3 pre-dose or from Visit 2 pre-bronchodilator). Analysis performed using analysis of covariance with covariates of treatment, age, sex, baseline clinic trough FEV1, pre-albuterol/salbutamol FEV1 at Visit 5, pack years smoked per randomization stratification and age when first treated with an inhaler per randomization stratification.
Outcome measures
| Measure |
FF 100 µg
n=37 Participants
Participants received fluticasone furoate (FF) 100 µg once daily in the morning by inhalation using a dry powder inhaler (DPI) for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via metered-dose inhaler (MDI) to be used on an as-needed basis (rescue medication) throughout the study.
|
FF/UMEC 100/15.6 µg
n=40 Participants
Participants received FF 100 µg in combination with umeclidinium bromide (UMEC) 15.6 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
|
FF/UMEC 100/62.5 µg
n=38 Participants
Participants received FF 100 µg in combination with UMEC 62.5 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
|
FF/UMEC 100/125 µg
n=42 Participants
Participants received FF 100 µg in combination with UMEC 125 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
|
FF/UMEC 100/250 µg
n=80 Participants
Participants received FF 100 µg in combination with UMEC 250 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
|
FF/VI 100/25 µg
n=80 Participants
Participants received FF 100 µg in combination with vilanterol trifenatate (VI) 25 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
|
|---|---|---|---|---|---|---|
|
Change in Clinic FEV1 Following 2 Puffs of Albuterol/Salbutamol Given 3 Hours Post-study Treatment Dose at Visit 5/Day 28
|
0.249 Liters (L)
Standard Error 0.0287
|
0.161 Liters (L)
Standard Error 0.0284
|
0.159 Liters (L)
Standard Error 0.0284
|
0.160 Liters (L)
Standard Error 0.0262
|
0.189 Liters (L)
Standard Error 0.0202
|
0.087 Liters (L)
Standard Error 0.0209
|
Adverse Events
FF 100 µg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
FF/UMEC 100/15.6 µg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
FF/UMEC 100/62.5 µg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
FF/UMEC 100/125 µg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
FF/UMEC 100/250 µg
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
FF/VI 100/25 µg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
FF/UMEC/VI 100/250/25 µg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FF 100 µg
n=111 participants at risk
Participants received fluticasone furoate (FF) 100 µg once daily in the morning by inhalation using a dry powder inhaler (DPI) for 4 weeks during Treatment Phase A and 1 week during Treatment Phase C. In addition, all participants received supplemental albuterol/salbutamol via metered-dose inhaler (MDI) to be used on an as-needed basis (rescue medication) throughout the study.
|
FF/UMEC 100/15.6 µg
n=42 participants at risk
Participants received FF 100 µg in combination with umeclidinium bromide (UMEC) 15.6 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
|
FF/UMEC 100/62.5 µg
n=40 participants at risk
Participants received FF 100 µg in combination with UMEC 62.5 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
|
FF/UMEC 100/125 µg
n=46 participants at risk
Participants received FF 100 µg in combination with UMEC 125 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
|
FF/UMEC 100/250 µg
n=210 participants at risk
Participants received FF 100 µg in combination with UMEC 250 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A and 1 week during Treatment Phase B and C. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
|
FF/VI 100/25 µg
n=146 participants at risk
Participants received FF 100 µg in combination with vilanterol trifenatate (VI) 25 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A and 1 week during Treatment Phase C. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
|
FF/UMEC/VI 100/250/25 µg
n=163 participants at risk
Participants received FF 100 µg in combination with umeclidinium bromide (UMEC) 250 µg and VI 25 µg once daily in the morning by inhalation using two separate DPIs (FF/UMEC 100/250 \& VI 25) for 1 week during Treatment Phase B and C. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/111 • AEs and SAEs were collected from start of the run-in period until follow-up (Visit 8 + 7 days (+/- 2 days). SAEs related to participation or GSK concomitant medication were recorded from time of consent up to and including any follow up contact.
AEs and SAEs were collected for the ITT population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Assessed as related to participation might include; study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy.
|
0.00%
0/42 • AEs and SAEs were collected from start of the run-in period until follow-up (Visit 8 + 7 days (+/- 2 days). SAEs related to participation or GSK concomitant medication were recorded from time of consent up to and including any follow up contact.
AEs and SAEs were collected for the ITT population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Assessed as related to participation might include; study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy.
|
0.00%
0/40 • AEs and SAEs were collected from start of the run-in period until follow-up (Visit 8 + 7 days (+/- 2 days). SAEs related to participation or GSK concomitant medication were recorded from time of consent up to and including any follow up contact.
AEs and SAEs were collected for the ITT population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Assessed as related to participation might include; study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy.
|
0.00%
0/46 • AEs and SAEs were collected from start of the run-in period until follow-up (Visit 8 + 7 days (+/- 2 days). SAEs related to participation or GSK concomitant medication were recorded from time of consent up to and including any follow up contact.
AEs and SAEs were collected for the ITT population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Assessed as related to participation might include; study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy.
|
0.00%
0/210 • AEs and SAEs were collected from start of the run-in period until follow-up (Visit 8 + 7 days (+/- 2 days). SAEs related to participation or GSK concomitant medication were recorded from time of consent up to and including any follow up contact.
AEs and SAEs were collected for the ITT population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Assessed as related to participation might include; study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy.
|
0.00%
0/146 • AEs and SAEs were collected from start of the run-in period until follow-up (Visit 8 + 7 days (+/- 2 days). SAEs related to participation or GSK concomitant medication were recorded from time of consent up to and including any follow up contact.
AEs and SAEs were collected for the ITT population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Assessed as related to participation might include; study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy.
|
0.00%
0/163 • AEs and SAEs were collected from start of the run-in period until follow-up (Visit 8 + 7 days (+/- 2 days). SAEs related to participation or GSK concomitant medication were recorded from time of consent up to and including any follow up contact.
AEs and SAEs were collected for the ITT population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Assessed as related to participation might include; study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy.
|
|
Nervous system disorders
Transient ischaemic attack (TIA)
|
0.00%
0/111 • AEs and SAEs were collected from start of the run-in period until follow-up (Visit 8 + 7 days (+/- 2 days). SAEs related to participation or GSK concomitant medication were recorded from time of consent up to and including any follow up contact.
AEs and SAEs were collected for the ITT population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Assessed as related to participation might include; study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy.
|
0.00%
0/42 • AEs and SAEs were collected from start of the run-in period until follow-up (Visit 8 + 7 days (+/- 2 days). SAEs related to participation or GSK concomitant medication were recorded from time of consent up to and including any follow up contact.
AEs and SAEs were collected for the ITT population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Assessed as related to participation might include; study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy.
|
0.00%
0/40 • AEs and SAEs were collected from start of the run-in period until follow-up (Visit 8 + 7 days (+/- 2 days). SAEs related to participation or GSK concomitant medication were recorded from time of consent up to and including any follow up contact.
AEs and SAEs were collected for the ITT population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Assessed as related to participation might include; study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy.
|
0.00%
0/46 • AEs and SAEs were collected from start of the run-in period until follow-up (Visit 8 + 7 days (+/- 2 days). SAEs related to participation or GSK concomitant medication were recorded from time of consent up to and including any follow up contact.
AEs and SAEs were collected for the ITT population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Assessed as related to participation might include; study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy.
|
0.00%
0/210 • AEs and SAEs were collected from start of the run-in period until follow-up (Visit 8 + 7 days (+/- 2 days). SAEs related to participation or GSK concomitant medication were recorded from time of consent up to and including any follow up contact.
AEs and SAEs were collected for the ITT population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Assessed as related to participation might include; study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy.
|
0.00%
0/146 • AEs and SAEs were collected from start of the run-in period until follow-up (Visit 8 + 7 days (+/- 2 days). SAEs related to participation or GSK concomitant medication were recorded from time of consent up to and including any follow up contact.
AEs and SAEs were collected for the ITT population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Assessed as related to participation might include; study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy.
|
0.00%
0/163 • AEs and SAEs were collected from start of the run-in period until follow-up (Visit 8 + 7 days (+/- 2 days). SAEs related to participation or GSK concomitant medication were recorded from time of consent up to and including any follow up contact.
AEs and SAEs were collected for the ITT population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Assessed as related to participation might include; study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism (PE)
|
0.00%
0/111 • AEs and SAEs were collected from start of the run-in period until follow-up (Visit 8 + 7 days (+/- 2 days). SAEs related to participation or GSK concomitant medication were recorded from time of consent up to and including any follow up contact.
AEs and SAEs were collected for the ITT population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Assessed as related to participation might include; study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy.
|
0.00%
0/42 • AEs and SAEs were collected from start of the run-in period until follow-up (Visit 8 + 7 days (+/- 2 days). SAEs related to participation or GSK concomitant medication were recorded from time of consent up to and including any follow up contact.
AEs and SAEs were collected for the ITT population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Assessed as related to participation might include; study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy.
|
0.00%
0/40 • AEs and SAEs were collected from start of the run-in period until follow-up (Visit 8 + 7 days (+/- 2 days). SAEs related to participation or GSK concomitant medication were recorded from time of consent up to and including any follow up contact.
AEs and SAEs were collected for the ITT population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Assessed as related to participation might include; study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy.
|
0.00%
0/46 • AEs and SAEs were collected from start of the run-in period until follow-up (Visit 8 + 7 days (+/- 2 days). SAEs related to participation or GSK concomitant medication were recorded from time of consent up to and including any follow up contact.
AEs and SAEs were collected for the ITT population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Assessed as related to participation might include; study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy.
|
0.00%
0/210 • AEs and SAEs were collected from start of the run-in period until follow-up (Visit 8 + 7 days (+/- 2 days). SAEs related to participation or GSK concomitant medication were recorded from time of consent up to and including any follow up contact.
AEs and SAEs were collected for the ITT population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Assessed as related to participation might include; study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy.
|
0.00%
0/146 • AEs and SAEs were collected from start of the run-in period until follow-up (Visit 8 + 7 days (+/- 2 days). SAEs related to participation or GSK concomitant medication were recorded from time of consent up to and including any follow up contact.
AEs and SAEs were collected for the ITT population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Assessed as related to participation might include; study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy.
|
0.00%
0/163 • AEs and SAEs were collected from start of the run-in period until follow-up (Visit 8 + 7 days (+/- 2 days). SAEs related to participation or GSK concomitant medication were recorded from time of consent up to and including any follow up contact.
AEs and SAEs were collected for the ITT population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Assessed as related to participation might include; study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/111 • AEs and SAEs were collected from start of the run-in period until follow-up (Visit 8 + 7 days (+/- 2 days). SAEs related to participation or GSK concomitant medication were recorded from time of consent up to and including any follow up contact.
AEs and SAEs were collected for the ITT population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Assessed as related to participation might include; study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy.
|
0.00%
0/42 • AEs and SAEs were collected from start of the run-in period until follow-up (Visit 8 + 7 days (+/- 2 days). SAEs related to participation or GSK concomitant medication were recorded from time of consent up to and including any follow up contact.
AEs and SAEs were collected for the ITT population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Assessed as related to participation might include; study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy.
|
0.00%
0/40 • AEs and SAEs were collected from start of the run-in period until follow-up (Visit 8 + 7 days (+/- 2 days). SAEs related to participation or GSK concomitant medication were recorded from time of consent up to and including any follow up contact.
AEs and SAEs were collected for the ITT population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Assessed as related to participation might include; study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy.
|
0.00%
0/46 • AEs and SAEs were collected from start of the run-in period until follow-up (Visit 8 + 7 days (+/- 2 days). SAEs related to participation or GSK concomitant medication were recorded from time of consent up to and including any follow up contact.
AEs and SAEs were collected for the ITT population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Assessed as related to participation might include; study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy.
|
0.48%
1/210 • Number of events 1 • AEs and SAEs were collected from start of the run-in period until follow-up (Visit 8 + 7 days (+/- 2 days). SAEs related to participation or GSK concomitant medication were recorded from time of consent up to and including any follow up contact.
AEs and SAEs were collected for the ITT population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Assessed as related to participation might include; study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy.
|
0.00%
0/146 • AEs and SAEs were collected from start of the run-in period until follow-up (Visit 8 + 7 days (+/- 2 days). SAEs related to participation or GSK concomitant medication were recorded from time of consent up to and including any follow up contact.
AEs and SAEs were collected for the ITT population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Assessed as related to participation might include; study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy.
|
0.00%
0/163 • AEs and SAEs were collected from start of the run-in period until follow-up (Visit 8 + 7 days (+/- 2 days). SAEs related to participation or GSK concomitant medication were recorded from time of consent up to and including any follow up contact.
AEs and SAEs were collected for the ITT population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Assessed as related to participation might include; study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy.
|
Other adverse events
| Measure |
FF 100 µg
n=111 participants at risk
Participants received fluticasone furoate (FF) 100 µg once daily in the morning by inhalation using a dry powder inhaler (DPI) for 4 weeks during Treatment Phase A and 1 week during Treatment Phase C. In addition, all participants received supplemental albuterol/salbutamol via metered-dose inhaler (MDI) to be used on an as-needed basis (rescue medication) throughout the study.
|
FF/UMEC 100/15.6 µg
n=42 participants at risk
Participants received FF 100 µg in combination with umeclidinium bromide (UMEC) 15.6 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
|
FF/UMEC 100/62.5 µg
n=40 participants at risk
Participants received FF 100 µg in combination with UMEC 62.5 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
|
FF/UMEC 100/125 µg
n=46 participants at risk
Participants received FF 100 µg in combination with UMEC 125 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
|
FF/UMEC 100/250 µg
n=210 participants at risk
Participants received FF 100 µg in combination with UMEC 250 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A and 1 week during Treatment Phase B and C. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
|
FF/VI 100/25 µg
n=146 participants at risk
Participants received FF 100 µg in combination with vilanterol trifenatate (VI) 25 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A and 1 week during Treatment Phase C. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
|
FF/UMEC/VI 100/250/25 µg
n=163 participants at risk
Participants received FF 100 µg in combination with umeclidinium bromide (UMEC) 250 µg and VI 25 µg once daily in the morning by inhalation using two separate DPIs (FF/UMEC 100/250 \& VI 25) for 1 week during Treatment Phase B and C. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/111 • AEs and SAEs were collected from start of the run-in period until follow-up (Visit 8 + 7 days (+/- 2 days). SAEs related to participation or GSK concomitant medication were recorded from time of consent up to and including any follow up contact.
AEs and SAEs were collected for the ITT population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Assessed as related to participation might include; study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy.
|
7.1%
3/42 • Number of events 3 • AEs and SAEs were collected from start of the run-in period until follow-up (Visit 8 + 7 days (+/- 2 days). SAEs related to participation or GSK concomitant medication were recorded from time of consent up to and including any follow up contact.
AEs and SAEs were collected for the ITT population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Assessed as related to participation might include; study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy.
|
2.5%
1/40 • Number of events 1 • AEs and SAEs were collected from start of the run-in period until follow-up (Visit 8 + 7 days (+/- 2 days). SAEs related to participation or GSK concomitant medication were recorded from time of consent up to and including any follow up contact.
AEs and SAEs were collected for the ITT population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Assessed as related to participation might include; study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy.
|
0.00%
0/46 • AEs and SAEs were collected from start of the run-in period until follow-up (Visit 8 + 7 days (+/- 2 days). SAEs related to participation or GSK concomitant medication were recorded from time of consent up to and including any follow up contact.
AEs and SAEs were collected for the ITT population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Assessed as related to participation might include; study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy.
|
0.48%
1/210 • Number of events 1 • AEs and SAEs were collected from start of the run-in period until follow-up (Visit 8 + 7 days (+/- 2 days). SAEs related to participation or GSK concomitant medication were recorded from time of consent up to and including any follow up contact.
AEs and SAEs were collected for the ITT population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Assessed as related to participation might include; study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy.
|
0.00%
0/146 • AEs and SAEs were collected from start of the run-in period until follow-up (Visit 8 + 7 days (+/- 2 days). SAEs related to participation or GSK concomitant medication were recorded from time of consent up to and including any follow up contact.
AEs and SAEs were collected for the ITT population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Assessed as related to participation might include; study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy.
|
0.00%
0/163 • AEs and SAEs were collected from start of the run-in period until follow-up (Visit 8 + 7 days (+/- 2 days). SAEs related to participation or GSK concomitant medication were recorded from time of consent up to and including any follow up contact.
AEs and SAEs were collected for the ITT population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Assessed as related to participation might include; study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy.
|
|
Infections and infestations
Nasopharyngitis
|
5.4%
6/111 • Number of events 6 • AEs and SAEs were collected from start of the run-in period until follow-up (Visit 8 + 7 days (+/- 2 days). SAEs related to participation or GSK concomitant medication were recorded from time of consent up to and including any follow up contact.
AEs and SAEs were collected for the ITT population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Assessed as related to participation might include; study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy.
|
7.1%
3/42 • Number of events 3 • AEs and SAEs were collected from start of the run-in period until follow-up (Visit 8 + 7 days (+/- 2 days). SAEs related to participation or GSK concomitant medication were recorded from time of consent up to and including any follow up contact.
AEs and SAEs were collected for the ITT population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Assessed as related to participation might include; study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy.
|
5.0%
2/40 • Number of events 3 • AEs and SAEs were collected from start of the run-in period until follow-up (Visit 8 + 7 days (+/- 2 days). SAEs related to participation or GSK concomitant medication were recorded from time of consent up to and including any follow up contact.
AEs and SAEs were collected for the ITT population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Assessed as related to participation might include; study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy.
|
4.3%
2/46 • Number of events 2 • AEs and SAEs were collected from start of the run-in period until follow-up (Visit 8 + 7 days (+/- 2 days). SAEs related to participation or GSK concomitant medication were recorded from time of consent up to and including any follow up contact.
AEs and SAEs were collected for the ITT population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Assessed as related to participation might include; study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy.
|
1.9%
4/210 • Number of events 4 • AEs and SAEs were collected from start of the run-in period until follow-up (Visit 8 + 7 days (+/- 2 days). SAEs related to participation or GSK concomitant medication were recorded from time of consent up to and including any follow up contact.
AEs and SAEs were collected for the ITT population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Assessed as related to participation might include; study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy.
|
2.7%
4/146 • Number of events 4 • AEs and SAEs were collected from start of the run-in period until follow-up (Visit 8 + 7 days (+/- 2 days). SAEs related to participation or GSK concomitant medication were recorded from time of consent up to and including any follow up contact.
AEs and SAEs were collected for the ITT population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Assessed as related to participation might include; study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy.
|
0.00%
0/163 • AEs and SAEs were collected from start of the run-in period until follow-up (Visit 8 + 7 days (+/- 2 days). SAEs related to participation or GSK concomitant medication were recorded from time of consent up to and including any follow up contact.
AEs and SAEs were collected for the ITT population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Assessed as related to participation might include; study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.90%
1/111 • Number of events 1 • AEs and SAEs were collected from start of the run-in period until follow-up (Visit 8 + 7 days (+/- 2 days). SAEs related to participation or GSK concomitant medication were recorded from time of consent up to and including any follow up contact.
AEs and SAEs were collected for the ITT population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Assessed as related to participation might include; study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy.
|
0.00%
0/42 • AEs and SAEs were collected from start of the run-in period until follow-up (Visit 8 + 7 days (+/- 2 days). SAEs related to participation or GSK concomitant medication were recorded from time of consent up to and including any follow up contact.
AEs and SAEs were collected for the ITT population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Assessed as related to participation might include; study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy.
|
2.5%
1/40 • Number of events 1 • AEs and SAEs were collected from start of the run-in period until follow-up (Visit 8 + 7 days (+/- 2 days). SAEs related to participation or GSK concomitant medication were recorded from time of consent up to and including any follow up contact.
AEs and SAEs were collected for the ITT population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Assessed as related to participation might include; study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy.
|
6.5%
3/46 • Number of events 3 • AEs and SAEs were collected from start of the run-in period until follow-up (Visit 8 + 7 days (+/- 2 days). SAEs related to participation or GSK concomitant medication were recorded from time of consent up to and including any follow up contact.
AEs and SAEs were collected for the ITT population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Assessed as related to participation might include; study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy.
|
0.00%
0/210 • AEs and SAEs were collected from start of the run-in period until follow-up (Visit 8 + 7 days (+/- 2 days). SAEs related to participation or GSK concomitant medication were recorded from time of consent up to and including any follow up contact.
AEs and SAEs were collected for the ITT population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Assessed as related to participation might include; study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy.
|
0.00%
0/146 • AEs and SAEs were collected from start of the run-in period until follow-up (Visit 8 + 7 days (+/- 2 days). SAEs related to participation or GSK concomitant medication were recorded from time of consent up to and including any follow up contact.
AEs and SAEs were collected for the ITT population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Assessed as related to participation might include; study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy.
|
0.00%
0/163 • AEs and SAEs were collected from start of the run-in period until follow-up (Visit 8 + 7 days (+/- 2 days). SAEs related to participation or GSK concomitant medication were recorded from time of consent up to and including any follow up contact.
AEs and SAEs were collected for the ITT population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Assessed as related to participation might include; study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
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