Trial Outcomes & Findings for A Long-term Safety Study of Fixed Dose Combination Therapy Fluticasone Furoate/Umeclidinium Bromide/Vilanterol Trifenatate in Japanese Subjects With Asthma (NCT NCT03184987)
NCT ID: NCT03184987
Last Updated: 2020-05-29
Results Overview
An adverse event (AE) is any untoward medical occurrence in clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose: result in death, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, congenital anomaly/birth defect, other important medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the outcome mentioned before. Intent-To-Treat (ITT) Population comprised of all participants who received at least one dose of study treatment in the treatment period.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
111 participants
Primary outcome timeframe
Up to Week 52
Results posted on
2020-05-29
Participant Flow
This study evaluated long-term safety of fixed dose combination therapy Fluticasone Furoate/Umeclidinium Bromide/Vilanterol Trifenatate (FF/UMEC/VI) in Japanese participants with asthma. The study was conducted across multiple centers in Japan.
A total of 114 participants were screened, of which 1 failed screening and 2 participants were run-in failures and 111 participants received study treatment.
Participant milestones
| Measure |
FF/UMEC/VI 100/62.5/25 mcg
Participants received FF/UMEC/VI 100/62.5/25 microgram (mcg) inhalation powder via ELLIPTA, once daily in the morning for 52 weeks. Participants received salbutamol via metered-dose inhaler as a rescue medication during the study.
|
FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg
Participants were administered FF/UMEC/VI 100/62.5/25 mcg via ELLIPTA once daily in the morning for 24 weeks. Participants with inadequate asthma control as assessed by Asthma Control Questionnaire-7 (ACQ-7) (i.e. ACQ score \>0.75) could be switched treatment from FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg at Week 24 of the treatment period based on the ACQ-7. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.
|
FF/UMEC/VI 200/62.5/25 mcg
Participants received FF/UMEC/VI 200/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.
|
|---|---|---|---|
|
Overall Study
STARTED
|
47
|
9
|
55
|
|
Overall Study
COMPLETED
|
46
|
8
|
51
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
4
|
Reasons for withdrawal
| Measure |
FF/UMEC/VI 100/62.5/25 mcg
Participants received FF/UMEC/VI 100/62.5/25 microgram (mcg) inhalation powder via ELLIPTA, once daily in the morning for 52 weeks. Participants received salbutamol via metered-dose inhaler as a rescue medication during the study.
|
FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg
Participants were administered FF/UMEC/VI 100/62.5/25 mcg via ELLIPTA once daily in the morning for 24 weeks. Participants with inadequate asthma control as assessed by Asthma Control Questionnaire-7 (ACQ-7) (i.e. ACQ score \>0.75) could be switched treatment from FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg at Week 24 of the treatment period based on the ACQ-7. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.
|
FF/UMEC/VI 200/62.5/25 mcg
Participants received FF/UMEC/VI 200/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
2
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
1
|
Baseline Characteristics
A Long-term Safety Study of Fixed Dose Combination Therapy Fluticasone Furoate/Umeclidinium Bromide/Vilanterol Trifenatate in Japanese Subjects With Asthma
Baseline characteristics by cohort
| Measure |
FF/UMEC/VI 100/62.5/25 mcg
n=47 Participants
Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants received salbutamol via metered-dose inhaler as a rescue medication during the study.
|
FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg
n=9 Participants
Participants were administered FF/UMEC/VI 100/62.5/25 mcg via ELLIPTA once daily in the morning for 24 weeks. Participants with inadequate asthma control as assessed by Asthma Control Questionnaire-7 (ACQ-7) (i.e. ACQ score \>0.75) could be switched treatment from FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg at Week 24 of the treatment period based on the ACQ-7. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.
|
FF/UMEC/VI 200/62.5/25 mcg
n=55 Participants
Participants received FF/UMEC/VI 200/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.
|
Total
n=111 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
48.0 Years
STANDARD_DEVIATION 14.28 • n=5 Participants
|
48.4 Years
STANDARD_DEVIATION 7.76 • n=7 Participants
|
53.8 Years
STANDARD_DEVIATION 12.91 • n=5 Participants
|
50.9 Years
STANDARD_DEVIATION 13.41 • n=4 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian-Japanese/East Asian Heritage (EAH)/South EAH
|
47 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
111 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to Week 52Population: ITT Population.
An adverse event (AE) is any untoward medical occurrence in clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose: result in death, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, congenital anomaly/birth defect, other important medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the outcome mentioned before. Intent-To-Treat (ITT) Population comprised of all participants who received at least one dose of study treatment in the treatment period.
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 mcg
n=47 Participants
Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants received salbutamol via metered-dose inhaler as a rescue medication during the study.
|
FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg
n=9 Participants
Participants were administered FF/UMEC/VI 100/62.5/25 mcg via ELLIPTA once daily in the morning for 24 weeks. Participants with inadequate asthma control as assessed by Asthma Control Questionnaire-7 (ACQ-7) (i.e. ACQ score \>0.75) could be switched treatment from FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg at Week 24 of the treatment period based on the ACQ-7. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.
|
FF/UMEC/VI 200/62.5/25 mcg
n=55 Participants
Participants received FF/UMEC/VI 200/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.
|
|---|---|---|---|
|
Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)
Non-SAEs
|
23 Participants
|
7 Participants
|
32 Participants
|
|
Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)
SAEs
|
1 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Weeks 4, 12, 24, 36 and 52Population: ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood pressure was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value.
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 mcg
n=47 Participants
Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants received salbutamol via metered-dose inhaler as a rescue medication during the study.
|
FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg
n=9 Participants
Participants were administered FF/UMEC/VI 100/62.5/25 mcg via ELLIPTA once daily in the morning for 24 weeks. Participants with inadequate asthma control as assessed by Asthma Control Questionnaire-7 (ACQ-7) (i.e. ACQ score \>0.75) could be switched treatment from FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg at Week 24 of the treatment period based on the ACQ-7. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.
|
FF/UMEC/VI 200/62.5/25 mcg
n=55 Participants
Participants received FF/UMEC/VI 200/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.
|
|---|---|---|---|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP: Week 4, n=47,9,55
|
-1.9 Millimeters of mercury
Standard Deviation 11.27
|
7.4 Millimeters of mercury
Standard Deviation 9.91
|
2.7 Millimeters of mercury
Standard Deviation 12.66
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP: Week 24, n=46,9,52
|
0.4 Millimeters of mercury
Standard Deviation 8.32
|
1.6 Millimeters of mercury
Standard Deviation 5.75
|
2.1 Millimeters of mercury
Standard Deviation 8.22
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP: Week 12, n=47,9,55
|
-1.7 Millimeters of mercury
Standard Deviation 10.35
|
1.2 Millimeters of mercury
Standard Deviation 12.25
|
4.6 Millimeters of mercury
Standard Deviation 12.10
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP: Week 24, n=46,9,52
|
-0.9 Millimeters of mercury
Standard Deviation 11.68
|
-1.0 Millimeters of mercury
Standard Deviation 13.87
|
3.3 Millimeters of mercury
Standard Deviation 12.85
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP: Week 36, n=46,8,52
|
2.0 Millimeters of mercury
Standard Deviation 12.60
|
5.0 Millimeters of mercury
Standard Deviation 15.92
|
4.6 Millimeters of mercury
Standard Deviation 12.62
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP: Week 52, n=46,8,51
|
0.1 Millimeters of mercury
Standard Deviation 9.21
|
3.6 Millimeters of mercury
Standard Deviation 9.07
|
3.4 Millimeters of mercury
Standard Deviation 13.09
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP: Week 4, n=47,9,55
|
1.6 Millimeters of mercury
Standard Deviation 6.04
|
3.3 Millimeters of mercury
Standard Deviation 4.64
|
-0.2 Millimeters of mercury
Standard Deviation 7.63
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP: Week 12, n=47,9,55
|
-0.1 Millimeters of mercury
Standard Deviation 9.07
|
-0.2 Millimeters of mercury
Standard Deviation 7.76
|
1.7 Millimeters of mercury
Standard Deviation 8.66
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP: Week 36, n=46,8,52
|
4.2 Millimeters of mercury
Standard Deviation 7.18
|
4.8 Millimeters of mercury
Standard Deviation 7.40
|
3.1 Millimeters of mercury
Standard Deviation 9.93
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP: Week 52, n=46,8,51
|
2.1 Millimeters of mercury
Standard Deviation 6.98
|
2.4 Millimeters of mercury
Standard Deviation 3.70
|
2.5 Millimeters of mercury
Standard Deviation 9.60
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Weeks 4, 12, 24, 36 and 52Population: ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Pulse rate was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value.
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 mcg
n=47 Participants
Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants received salbutamol via metered-dose inhaler as a rescue medication during the study.
|
FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg
n=9 Participants
Participants were administered FF/UMEC/VI 100/62.5/25 mcg via ELLIPTA once daily in the morning for 24 weeks. Participants with inadequate asthma control as assessed by Asthma Control Questionnaire-7 (ACQ-7) (i.e. ACQ score \>0.75) could be switched treatment from FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg at Week 24 of the treatment period based on the ACQ-7. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.
|
FF/UMEC/VI 200/62.5/25 mcg
n=55 Participants
Participants received FF/UMEC/VI 200/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.
|
|---|---|---|---|
|
Change From Baseline in Pulse Rate
Week 4, n=47,9,55
|
0.3 Beats per minute
Standard Deviation 9.28
|
5.9 Beats per minute
Standard Deviation 7.04
|
1.6 Beats per minute
Standard Deviation 7.85
|
|
Change From Baseline in Pulse Rate
Week 12, n=47,9,55
|
-0.1 Beats per minute
Standard Deviation 9.58
|
4.4 Beats per minute
Standard Deviation 7.14
|
2.3 Beats per minute
Standard Deviation 7.55
|
|
Change From Baseline in Pulse Rate
Week 24, n=46,9,52
|
-2.6 Beats per minute
Standard Deviation 8.63
|
4.6 Beats per minute
Standard Deviation 7.73
|
-1.8 Beats per minute
Standard Deviation 6.35
|
|
Change From Baseline in Pulse Rate
Week 36, n=46,8,52
|
2.4 Beats per minute
Standard Deviation 11.65
|
7.0 Beats per minute
Standard Deviation 9.27
|
4.2 Beats per minute
Standard Deviation 8.41
|
|
Change From Baseline in Pulse Rate
Week 52, n=46,8,51
|
-0.3 Beats per minute
Standard Deviation 8.94
|
-1.4 Beats per minute
Standard Deviation 2.45
|
1.7 Beats per minute
Standard Deviation 9.22
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Weeks 4, 24 and 52Population: ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Single 12-lead electrocardiograms (ECG) were obtained using an automated ECG machine that measured PR Interval and QTcF Interval. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value.
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 mcg
n=47 Participants
Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants received salbutamol via metered-dose inhaler as a rescue medication during the study.
|
FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg
n=9 Participants
Participants were administered FF/UMEC/VI 100/62.5/25 mcg via ELLIPTA once daily in the morning for 24 weeks. Participants with inadequate asthma control as assessed by Asthma Control Questionnaire-7 (ACQ-7) (i.e. ACQ score \>0.75) could be switched treatment from FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg at Week 24 of the treatment period based on the ACQ-7. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.
|
FF/UMEC/VI 200/62.5/25 mcg
n=55 Participants
Participants received FF/UMEC/VI 200/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.
|
|---|---|---|---|
|
Change From Baseline in PR Interval and QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF)
QTcF Interval: Week 4, n=47,9,55
|
-1.890 Milliseconds
Standard Deviation 11.3898
|
1.757 Milliseconds
Standard Deviation 13.8084
|
3.914 Milliseconds
Standard Deviation 27.5206
|
|
Change From Baseline in PR Interval and QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF)
QTcF Interval: Week 52, n=46,8,51
|
1.745 Milliseconds
Standard Deviation 13.3558
|
3.243 Milliseconds
Standard Deviation 17.5127
|
0.969 Milliseconds
Standard Deviation 15.3699
|
|
Change From Baseline in PR Interval and QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF)
PR Interval: Week 4, n=47,9,55
|
-2.3 Milliseconds
Standard Deviation 10.12
|
5.1 Milliseconds
Standard Deviation 10.62
|
-0.3 Milliseconds
Standard Deviation 9.40
|
|
Change From Baseline in PR Interval and QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF)
PR Interval: Week 24, n=46,9,52
|
1.5 Milliseconds
Standard Deviation 9.43
|
-0.4 Milliseconds
Standard Deviation 12.12
|
2.5 Milliseconds
Standard Deviation 10.29
|
|
Change From Baseline in PR Interval and QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF)
PR Interval: Week 52, n=46,8,50
|
-1.3 Milliseconds
Standard Deviation 10.11
|
1.3 Milliseconds
Standard Deviation 9.57
|
1.7 Milliseconds
Standard Deviation 8.97
|
|
Change From Baseline in PR Interval and QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF)
QTcF Interval: Week 24, n=46,9,52
|
-1.577 Milliseconds
Standard Deviation 10.4434
|
7.578 Milliseconds
Standard Deviation 8.0630
|
-3.265 Milliseconds
Standard Deviation 14.3663
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Weeks 12, 24 and 52Population: ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value.
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 mcg
n=47 Participants
Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants received salbutamol via metered-dose inhaler as a rescue medication during the study.
|
FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg
n=9 Participants
Participants were administered FF/UMEC/VI 100/62.5/25 mcg via ELLIPTA once daily in the morning for 24 weeks. Participants with inadequate asthma control as assessed by Asthma Control Questionnaire-7 (ACQ-7) (i.e. ACQ score \>0.75) could be switched treatment from FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg at Week 24 of the treatment period based on the ACQ-7. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.
|
FF/UMEC/VI 200/62.5/25 mcg
n=55 Participants
Participants received FF/UMEC/VI 200/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.
|
|---|---|---|---|
|
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Week 52, n=46,8,51
|
0.07 Picograms
Standard Deviation 0.915
|
0.66 Picograms
Standard Deviation 1.571
|
0.22 Picograms
Standard Deviation 0.833
|
|
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Week 12, n=47,9,55
|
-0.04 Picograms
Standard Deviation 0.591
|
0.49 Picograms
Standard Deviation 1.190
|
0.09 Picograms
Standard Deviation 0.803
|
|
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Week 24, n=46,9,52
|
0.41 Picograms
Standard Deviation 0.674
|
0.76 Picograms
Standard Deviation 1.254
|
0.35 Picograms
Standard Deviation 0.764
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Weeks 12, 24 and 52Population: ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value.
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 mcg
n=47 Participants
Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants received salbutamol via metered-dose inhaler as a rescue medication during the study.
|
FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg
n=9 Participants
Participants were administered FF/UMEC/VI 100/62.5/25 mcg via ELLIPTA once daily in the morning for 24 weeks. Participants with inadequate asthma control as assessed by Asthma Control Questionnaire-7 (ACQ-7) (i.e. ACQ score \>0.75) could be switched treatment from FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg at Week 24 of the treatment period based on the ACQ-7. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.
|
FF/UMEC/VI 200/62.5/25 mcg
n=55 Participants
Participants received FF/UMEC/VI 200/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.
|
|---|---|---|---|
|
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Week 12, n=47,9,55
|
-0.55 Femtoliters
Standard Deviation 1.525
|
0.90 Femtoliters
Standard Deviation 3.240
|
-0.20 Femtoliters
Standard Deviation 2.112
|
|
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Week 24, n=46,9,52
|
0.35 Femtoliters
Standard Deviation 1.499
|
1.49 Femtoliters
Standard Deviation 2.336
|
0.69 Femtoliters
Standard Deviation 2.208
|
|
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Week 52, n=46,8,51
|
0.21 Femtoliters
Standard Deviation 1.978
|
1.76 Femtoliters
Standard Deviation 2.753
|
0.55 Femtoliters
Standard Deviation 2.707
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Weeks 12, 24 and 52Population: ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected to analyze the hematology parameter: erythrocytes. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value.
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 mcg
n=47 Participants
Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants received salbutamol via metered-dose inhaler as a rescue medication during the study.
|
FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg
n=9 Participants
Participants were administered FF/UMEC/VI 100/62.5/25 mcg via ELLIPTA once daily in the morning for 24 weeks. Participants with inadequate asthma control as assessed by Asthma Control Questionnaire-7 (ACQ-7) (i.e. ACQ score \>0.75) could be switched treatment from FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg at Week 24 of the treatment period based on the ACQ-7. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.
|
FF/UMEC/VI 200/62.5/25 mcg
n=55 Participants
Participants received FF/UMEC/VI 200/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.
|
|---|---|---|---|
|
Change From Baseline in Hematology Parameter: Erythrocytes
Week 12, n=47,9,55
|
-0.084 10^12 cells per liter
Standard Deviation 0.2046
|
-0.161 10^12 cells per liter
Standard Deviation 0.2421
|
-0.056 10^12 cells per liter
Standard Deviation 0.1868
|
|
Change From Baseline in Hematology Parameter: Erythrocytes
Week 24, n=46,9,52
|
-0.123 10^12 cells per liter
Standard Deviation 0.1908
|
-0.109 10^12 cells per liter
Standard Deviation 0.2158
|
-0.101 10^12 cells per liter
Standard Deviation 0.2114
|
|
Change From Baseline in Hematology Parameter: Erythrocytes
Week 52, n=46,8,51
|
-0.024 10^12 cells per liter
Standard Deviation 0.1905
|
-0.055 10^12 cells per liter
Standard Deviation 0.2321
|
-0.032 10^12 cells per liter
Standard Deviation 0.2026
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Weeks 12, 24 and 52Population: ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value.
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 mcg
n=47 Participants
Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants received salbutamol via metered-dose inhaler as a rescue medication during the study.
|
FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg
n=9 Participants
Participants were administered FF/UMEC/VI 100/62.5/25 mcg via ELLIPTA once daily in the morning for 24 weeks. Participants with inadequate asthma control as assessed by Asthma Control Questionnaire-7 (ACQ-7) (i.e. ACQ score \>0.75) could be switched treatment from FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg at Week 24 of the treatment period based on the ACQ-7. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.
|
FF/UMEC/VI 200/62.5/25 mcg
n=55 Participants
Participants received FF/UMEC/VI 200/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.
|
|---|---|---|---|
|
Change From Baseline in Hematology Parameter: Hematocrit
Week 24, n=46,9,52
|
-0.0100 Percentage of red blood cells in blood
Standard Deviation 0.01627
|
-0.0029 Percentage of red blood cells in blood
Standard Deviation 0.01527
|
-0.0063 Percentage of red blood cells in blood
Standard Deviation 0.01878
|
|
Change From Baseline in Hematology Parameter: Hematocrit
Week 12, n=47,9,55
|
-0.0102 Percentage of red blood cells in blood
Standard Deviation 0.01714
|
-0.0103 Percentage of red blood cells in blood
Standard Deviation 0.02148
|
-0.0061 Percentage of red blood cells in blood
Standard Deviation 0.01616
|
|
Change From Baseline in Hematology Parameter: Hematocrit
Week 52, n=46,8,51
|
-0.0011 Percentage of red blood cells in blood
Standard Deviation 0.01602
|
0.0034 Percentage of red blood cells in blood
Standard Deviation 0.02251
|
0.0001 Percentage of red blood cells in blood
Standard Deviation 0.01749
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Weeks 12, 24 and 52Population: ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected to analyze the hematology parameter: hemoglobin. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value.
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 mcg
n=47 Participants
Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants received salbutamol via metered-dose inhaler as a rescue medication during the study.
|
FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg
n=9 Participants
Participants were administered FF/UMEC/VI 100/62.5/25 mcg via ELLIPTA once daily in the morning for 24 weeks. Participants with inadequate asthma control as assessed by Asthma Control Questionnaire-7 (ACQ-7) (i.e. ACQ score \>0.75) could be switched treatment from FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg at Week 24 of the treatment period based on the ACQ-7. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.
|
FF/UMEC/VI 200/62.5/25 mcg
n=55 Participants
Participants received FF/UMEC/VI 200/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.
|
|---|---|---|---|
|
Change From Baseline in Hematology Parameter: Hemoglobin
Week 24, n=46,9,52
|
-2.0 Grams per liter
Standard Deviation 6.33
|
0.2 Grams per liter
Standard Deviation 6.20
|
-1.5 Grams per liter
Standard Deviation 5.77
|
|
Change From Baseline in Hematology Parameter: Hemoglobin
Week 52, n=46,8,51
|
-0.4 Grams per liter
Standard Deviation 6.47
|
1.4 Grams per liter
Standard Deviation 9.32
|
0.3 Grams per liter
Standard Deviation 6.01
|
|
Change From Baseline in Hematology Parameter: Hemoglobin
Week 12, n=47,9,55
|
-2.6 Grams per liter
Standard Deviation 6.19
|
-2.4 Grams per liter
Standard Deviation 7.92
|
-1.3 Grams per liter
Standard Deviation 5.66
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Weeks 12, 24 and 52Population: ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected to analyze the hematology parameter: platelet count. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value.
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 mcg
n=47 Participants
Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants received salbutamol via metered-dose inhaler as a rescue medication during the study.
|
FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg
n=9 Participants
Participants were administered FF/UMEC/VI 100/62.5/25 mcg via ELLIPTA once daily in the morning for 24 weeks. Participants with inadequate asthma control as assessed by Asthma Control Questionnaire-7 (ACQ-7) (i.e. ACQ score \>0.75) could be switched treatment from FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg at Week 24 of the treatment period based on the ACQ-7. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.
|
FF/UMEC/VI 200/62.5/25 mcg
n=55 Participants
Participants received FF/UMEC/VI 200/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.
|
|---|---|---|---|
|
Change From Baseline in Hematology Parameter: Platelet Count
Week 52, n=46,8,51
|
-2.8 10^9 cells per liter
Standard Deviation 27.48
|
-18.4 10^9 cells per liter
Standard Deviation 51.83
|
3.3 10^9 cells per liter
Standard Deviation 25.73
|
|
Change From Baseline in Hematology Parameter: Platelet Count
Week 12, n=47,9,55
|
3.8 10^9 cells per liter
Standard Deviation 27.46
|
-17.7 10^9 cells per liter
Standard Deviation 37.26
|
4.8 10^9 cells per liter
Standard Deviation 33.99
|
|
Change From Baseline in Hematology Parameter: Platelet Count
Week 24, n=46,9,52
|
3.1 10^9 cells per liter
Standard Deviation 28.67
|
-20.6 10^9 cells per liter
Standard Deviation 54.69
|
4.6 10^9 cells per liter
Standard Deviation 39.72
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Weeks 12, 24 and 52Population: ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected to analyze the hematology parameter: Basophils/Leukocytes. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value.
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 mcg
n=47 Participants
Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants received salbutamol via metered-dose inhaler as a rescue medication during the study.
|
FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg
n=9 Participants
Participants were administered FF/UMEC/VI 100/62.5/25 mcg via ELLIPTA once daily in the morning for 24 weeks. Participants with inadequate asthma control as assessed by Asthma Control Questionnaire-7 (ACQ-7) (i.e. ACQ score \>0.75) could be switched treatment from FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg at Week 24 of the treatment period based on the ACQ-7. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.
|
FF/UMEC/VI 200/62.5/25 mcg
n=55 Participants
Participants received FF/UMEC/VI 200/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.
|
|---|---|---|---|
|
Change From Baseline in Hematology Parameter: Basophils/Leukocytes
Week 12, n=47,9,55
|
0.01 Percentage of basophil in leukocytes
Standard Deviation 0.352
|
-0.03 Percentage of basophil in leukocytes
Standard Deviation 0.600
|
-0.10 Percentage of basophil in leukocytes
Standard Deviation 0.440
|
|
Change From Baseline in Hematology Parameter: Basophils/Leukocytes
Week 52, n=46,8,51
|
0.10 Percentage of basophil in leukocytes
Standard Deviation 0.373
|
0.01 Percentage of basophil in leukocytes
Standard Deviation 0.295
|
0.05 Percentage of basophil in leukocytes
Standard Deviation 0.363
|
|
Change From Baseline in Hematology Parameter: Basophils/Leukocytes
Week 24, n=46,9,52
|
0.02 Percentage of basophil in leukocytes
Standard Deviation 0.334
|
-0.03 Percentage of basophil in leukocytes
Standard Deviation 0.487
|
-0.05 Percentage of basophil in leukocytes
Standard Deviation 0.365
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Weeks 12, 24 and 52Population: ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected to analyze the hematology parameter: Eosinophils/Leukocytes. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value.
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 mcg
n=47 Participants
Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants received salbutamol via metered-dose inhaler as a rescue medication during the study.
|
FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg
n=9 Participants
Participants were administered FF/UMEC/VI 100/62.5/25 mcg via ELLIPTA once daily in the morning for 24 weeks. Participants with inadequate asthma control as assessed by Asthma Control Questionnaire-7 (ACQ-7) (i.e. ACQ score \>0.75) could be switched treatment from FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg at Week 24 of the treatment period based on the ACQ-7. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.
|
FF/UMEC/VI 200/62.5/25 mcg
n=55 Participants
Participants received FF/UMEC/VI 200/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.
|
|---|---|---|---|
|
Change From Baseline in Hematology Parameter: Eosinophils/Leukocytes
Week 12, n=47,9,55
|
-0.35 Percentage of eosinophils in leukocytes
Standard Deviation 2.140
|
-0.18 Percentage of eosinophils in leukocytes
Standard Deviation 3.500
|
-0.87 Percentage of eosinophils in leukocytes
Standard Deviation 3.553
|
|
Change From Baseline in Hematology Parameter: Eosinophils/Leukocytes
Week 24, n=46,9,52
|
-0.13 Percentage of eosinophils in leukocytes
Standard Deviation 2.694
|
1.68 Percentage of eosinophils in leukocytes
Standard Deviation 2.859
|
0.19 Percentage of eosinophils in leukocytes
Standard Deviation 3.015
|
|
Change From Baseline in Hematology Parameter: Eosinophils/Leukocytes
Week 52, n=46,8,51
|
0.58 Percentage of eosinophils in leukocytes
Standard Deviation 2.924
|
0.01 Percentage of eosinophils in leukocytes
Standard Deviation 5.046
|
0.13 Percentage of eosinophils in leukocytes
Standard Deviation 4.371
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Weeks 12, 24 and 52Population: ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected to analyze the hematology parameter: Lymphocytes/Leukocytes. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value.
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 mcg
n=47 Participants
Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants received salbutamol via metered-dose inhaler as a rescue medication during the study.
|
FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg
n=9 Participants
Participants were administered FF/UMEC/VI 100/62.5/25 mcg via ELLIPTA once daily in the morning for 24 weeks. Participants with inadequate asthma control as assessed by Asthma Control Questionnaire-7 (ACQ-7) (i.e. ACQ score \>0.75) could be switched treatment from FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg at Week 24 of the treatment period based on the ACQ-7. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.
|
FF/UMEC/VI 200/62.5/25 mcg
n=55 Participants
Participants received FF/UMEC/VI 200/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.
|
|---|---|---|---|
|
Change From Baseline in Hematology Parameter: Lymphocytes/Leukocytes
Week 52, n=46,8,51
|
-0.26 Percentage of lymphocytes in leukocytes
Standard Deviation 5.198
|
-0.07 Percentage of lymphocytes in leukocytes
Standard Deviation 7.054
|
-1.54 Percentage of lymphocytes in leukocytes
Standard Deviation 5.672
|
|
Change From Baseline in Hematology Parameter: Lymphocytes/Leukocytes
Week 12, n=47,9,55
|
-1.77 Percentage of lymphocytes in leukocytes
Standard Deviation 7.644
|
-0.12 Percentage of lymphocytes in leukocytes
Standard Deviation 6.009
|
-0.95 Percentage of lymphocytes in leukocytes
Standard Deviation 6.324
|
|
Change From Baseline in Hematology Parameter: Lymphocytes/Leukocytes
Week 24, n=46,9,52
|
-0.75 Percentage of lymphocytes in leukocytes
Standard Deviation 5.431
|
-3.20 Percentage of lymphocytes in leukocytes
Standard Deviation 6.279
|
-2.06 Percentage of lymphocytes in leukocytes
Standard Deviation 5.282
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Weeks 12, 24 and 52Population: ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected to analyze the hematology parameter: Monocytes/Leukocytes. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value.
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 mcg
n=47 Participants
Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants received salbutamol via metered-dose inhaler as a rescue medication during the study.
|
FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg
n=9 Participants
Participants were administered FF/UMEC/VI 100/62.5/25 mcg via ELLIPTA once daily in the morning for 24 weeks. Participants with inadequate asthma control as assessed by Asthma Control Questionnaire-7 (ACQ-7) (i.e. ACQ score \>0.75) could be switched treatment from FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg at Week 24 of the treatment period based on the ACQ-7. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.
|
FF/UMEC/VI 200/62.5/25 mcg
n=55 Participants
Participants received FF/UMEC/VI 200/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.
|
|---|---|---|---|
|
Change From Baseline in Hematology Parameter: Monocytes/Leukocytes
Week 12, n=47,9,55
|
-0.48 Percentage of monocytes in leukocytes
Standard Deviation 1.717
|
0.03 Percentage of monocytes in leukocytes
Standard Deviation 1.141
|
-0.34 Percentage of monocytes in leukocytes
Standard Deviation 1.229
|
|
Change From Baseline in Hematology Parameter: Monocytes/Leukocytes
Week 24, n=46,9,52
|
-0.49 Percentage of monocytes in leukocytes
Standard Deviation 1.518
|
0.20 Percentage of monocytes in leukocytes
Standard Deviation 1.683
|
0.17 Percentage of monocytes in leukocytes
Standard Deviation 1.468
|
|
Change From Baseline in Hematology Parameter: Monocytes/Leukocytes
Week 52, n=46,8,51
|
0.14 Percentage of monocytes in leukocytes
Standard Deviation 1.400
|
-0.19 Percentage of monocytes in leukocytes
Standard Deviation 1.174
|
-0.04 Percentage of monocytes in leukocytes
Standard Deviation 1.009
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Weeks 12, 24 and 52Population: ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected to analyze the hematology parameter: Neutrophils/Leukocytes. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value.
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 mcg
n=47 Participants
Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants received salbutamol via metered-dose inhaler as a rescue medication during the study.
|
FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg
n=9 Participants
Participants were administered FF/UMEC/VI 100/62.5/25 mcg via ELLIPTA once daily in the morning for 24 weeks. Participants with inadequate asthma control as assessed by Asthma Control Questionnaire-7 (ACQ-7) (i.e. ACQ score \>0.75) could be switched treatment from FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg at Week 24 of the treatment period based on the ACQ-7. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.
|
FF/UMEC/VI 200/62.5/25 mcg
n=55 Participants
Participants received FF/UMEC/VI 200/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.
|
|---|---|---|---|
|
Change From Baseline in Hematology Parameter: Neutrophils/Leukocytes
Week 12, n=47,9,55
|
2.59 Percentage of neutrophils in leukocytes
Standard Deviation 8.777
|
0.30 Percentage of neutrophils in leukocytes
Standard Deviation 7.925
|
2.26 Percentage of neutrophils in leukocytes
Standard Deviation 8.081
|
|
Change From Baseline in Hematology Parameter: Neutrophils/Leukocytes
Week 52, n=46,8,51
|
-0.56 Percentage of neutrophils in leukocytes
Standard Deviation 6.487
|
0.24 Percentage of neutrophils in leukocytes
Standard Deviation 8.451
|
1.40 Percentage of neutrophils in leukocytes
Standard Deviation 7.512
|
|
Change From Baseline in Hematology Parameter: Neutrophils/Leukocytes
Week 24, n=46,9,52
|
1.36 Percentage of neutrophils in leukocytes
Standard Deviation 6.599
|
1.36 Percentage of neutrophils in leukocytes
Standard Deviation 9.352
|
1.76 Percentage of neutrophils in leukocytes
Standard Deviation 7.257
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Weeks 12, 24 and 52Population: ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected to analyze the chemistry parameters: alanine aminotransferase, alkaline phosphatase and aspartate aminotransferase. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value.
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 mcg
n=47 Participants
Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants received salbutamol via metered-dose inhaler as a rescue medication during the study.
|
FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg
n=9 Participants
Participants were administered FF/UMEC/VI 100/62.5/25 mcg via ELLIPTA once daily in the morning for 24 weeks. Participants with inadequate asthma control as assessed by Asthma Control Questionnaire-7 (ACQ-7) (i.e. ACQ score \>0.75) could be switched treatment from FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg at Week 24 of the treatment period based on the ACQ-7. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.
|
FF/UMEC/VI 200/62.5/25 mcg
n=55 Participants
Participants received FF/UMEC/VI 200/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.
|
|---|---|---|---|
|
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase
Alanine aminotransferase: Week 12, n=47,9,55
|
-0.0 International units per liter
Standard Deviation 8.56
|
-2.1 International units per liter
Standard Deviation 6.51
|
-1.5 International units per liter
Standard Deviation 10.23
|
|
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase
Alanine aminotransferase: Week 24, n=46,9,52
|
-1.5 International units per liter
Standard Deviation 8.62
|
-0.4 International units per liter
Standard Deviation 4.50
|
0.3 International units per liter
Standard Deviation 13.91
|
|
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase
Alanine aminotransferase: Week 52, n=46,8,51
|
-2.3 International units per liter
Standard Deviation 10.07
|
-1.1 International units per liter
Standard Deviation 4.49
|
1.4 International units per liter
Standard Deviation 22.10
|
|
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase
Alkaline phosphatase: Week 12, n=47,9,55
|
1.0 International units per liter
Standard Deviation 22.83
|
2.0 International units per liter
Standard Deviation 14.56
|
-13.2 International units per liter
Standard Deviation 36.95
|
|
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase
Alkaline phosphatase: Week 52, n=46,8,51
|
2.3 International units per liter
Standard Deviation 26.70
|
-7.9 International units per liter
Standard Deviation 31.86
|
-7.2 International units per liter
Standard Deviation 38.89
|
|
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase
Aspartate aminotransferase: Week 12, n=47,9,55
|
-0.4 International units per liter
Standard Deviation 8.05
|
-0.6 International units per liter
Standard Deviation 2.70
|
-1.3 International units per liter
Standard Deviation 6.44
|
|
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase
Aspartate aminotransferase: Week 52, n=46,8,51
|
-2.1 International units per liter
Standard Deviation 9.80
|
0.3 International units per liter
Standard Deviation 3.15
|
0.6 International units per liter
Standard Deviation 11.36
|
|
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase
Alkaline phosphatase: Week 24, n=46,9,52
|
-4.3 International units per liter
Standard Deviation 20.89
|
2.6 International units per liter
Standard Deviation 30.69
|
-8.1 International units per liter
Standard Deviation 41.91
|
|
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase
Aspartate aminotransferase: Week 24, n=46,9,52
|
-2.0 International units per liter
Standard Deviation 8.10
|
0.6 International units per liter
Standard Deviation 2.46
|
-0.0 International units per liter
Standard Deviation 9.37
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Weeks 12, 24 and 52Population: ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected to analyze the chemistry parameters: albumin and protein. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value.
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 mcg
n=47 Participants
Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants received salbutamol via metered-dose inhaler as a rescue medication during the study.
|
FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg
n=9 Participants
Participants were administered FF/UMEC/VI 100/62.5/25 mcg via ELLIPTA once daily in the morning for 24 weeks. Participants with inadequate asthma control as assessed by Asthma Control Questionnaire-7 (ACQ-7) (i.e. ACQ score \>0.75) could be switched treatment from FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg at Week 24 of the treatment period based on the ACQ-7. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.
|
FF/UMEC/VI 200/62.5/25 mcg
n=55 Participants
Participants received FF/UMEC/VI 200/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.
|
|---|---|---|---|
|
Change From Baseline in Chemistry Parameters: Albumin, Protein
Protein: Week 24, n=46,9,52
|
-1.4 Grams per liter
Standard Deviation 2.59
|
-0.7 Grams per liter
Standard Deviation 3.71
|
-0.8 Grams per liter
Standard Deviation 3.10
|
|
Change From Baseline in Chemistry Parameters: Albumin, Protein
Protein: Week 52, n=46,8,51
|
-0.6 Grams per liter
Standard Deviation 3.12
|
-1.4 Grams per liter
Standard Deviation 4.07
|
-0.7 Grams per liter
Standard Deviation 3.17
|
|
Change From Baseline in Chemistry Parameters: Albumin, Protein
Albumin: Week 12, n=47,9,55
|
0.2 Grams per liter
Standard Deviation 2.60
|
0.4 Grams per liter
Standard Deviation 4.10
|
0.1 Grams per liter
Standard Deviation 2.27
|
|
Change From Baseline in Chemistry Parameters: Albumin, Protein
Albumin: Week 24, n=46,9,52
|
-0.3 Grams per liter
Standard Deviation 2.02
|
-0.1 Grams per liter
Standard Deviation 5.53
|
-0.3 Grams per liter
Standard Deviation 2.24
|
|
Change From Baseline in Chemistry Parameters: Albumin, Protein
Albumin: Week 52, n=46,8,51
|
-0.2 Grams per liter
Standard Deviation 2.27
|
-0.9 Grams per liter
Standard Deviation 3.80
|
-0.6 Grams per liter
Standard Deviation 1.93
|
|
Change From Baseline in Chemistry Parameters: Albumin, Protein
Protein: Week 12, n=47,9,55
|
-0.2 Grams per liter
Standard Deviation 3.06
|
-0.1 Grams per liter
Standard Deviation 3.79
|
-0.1 Grams per liter
Standard Deviation 3.43
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Weeks 12, 24 and 52Population: ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected to analyze the chemistry parameters: bilirubin, creatinine and direct bilirubin. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value.
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 mcg
n=47 Participants
Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants received salbutamol via metered-dose inhaler as a rescue medication during the study.
|
FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg
n=9 Participants
Participants were administered FF/UMEC/VI 100/62.5/25 mcg via ELLIPTA once daily in the morning for 24 weeks. Participants with inadequate asthma control as assessed by Asthma Control Questionnaire-7 (ACQ-7) (i.e. ACQ score \>0.75) could be switched treatment from FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg at Week 24 of the treatment period based on the ACQ-7. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.
|
FF/UMEC/VI 200/62.5/25 mcg
n=55 Participants
Participants received FF/UMEC/VI 200/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.
|
|---|---|---|---|
|
Change From Baseline in Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin
Bilirubin: Week 52, n=46,8,51
|
0.223 Micromoles per liter
Standard Deviation 3.0718
|
2.779 Micromoles per liter
Standard Deviation 1.8137
|
0.000 Micromoles per liter
Standard Deviation 3.2445
|
|
Change From Baseline in Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin
Creatinine: Week 12, n=47,9,55
|
0.3762 Micromoles per liter
Standard Deviation 5.16031
|
0.3929 Micromoles per liter
Standard Deviation 7.64431
|
1.2697 Micromoles per liter
Standard Deviation 6.83001
|
|
Change From Baseline in Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin
Creatinine: Week 24, n=46,9,52
|
2.1139 Micromoles per liter
Standard Deviation 4.90769
|
-0.4911 Micromoles per liter
Standard Deviation 5.04173
|
0.9860 Micromoles per liter
Standard Deviation 5.01490
|
|
Change From Baseline in Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin
Creatinine: Week 52, n=46,8,51
|
0.6918 Micromoles per liter
Standard Deviation 4.88441
|
-0.7735 Micromoles per liter
Standard Deviation 4.85194
|
0.9533 Micromoles per liter
Standard Deviation 5.52579
|
|
Change From Baseline in Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin
Direct bilirubin: Week 12, n=47,9,55
|
0.182 Micromoles per liter
Standard Deviation 1.4366
|
0.950 Micromoles per liter
Standard Deviation 0.9012
|
0.155 Micromoles per liter
Standard Deviation 1.2433
|
|
Change From Baseline in Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin
Bilirubin: Week 12, n=47,9,55
|
0.764 Micromoles per liter
Standard Deviation 3.5263
|
2.850 Micromoles per liter
Standard Deviation 2.7037
|
1.213 Micromoles per liter
Standard Deviation 3.0103
|
|
Change From Baseline in Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin
Bilirubin: Week 24, n=46,9,52
|
0.967 Micromoles per liter
Standard Deviation 2.8535
|
3.040 Micromoles per liter
Standard Deviation 3.8024
|
-0.230 Micromoles per liter
Standard Deviation 4.0214
|
|
Change From Baseline in Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin
Direct bilirubin: Week 24, n=46,9,52
|
0.149 Micromoles per liter
Standard Deviation 0.8701
|
1.140 Micromoles per liter
Standard Deviation 1.2092
|
-0.329 Micromoles per liter
Standard Deviation 1.3561
|
|
Change From Baseline in Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin
Direct bilirubin: Week 52, n=46,8,51
|
-0.223 Micromoles per liter
Standard Deviation 1.3299
|
0.641 Micromoles per liter
Standard Deviation 0.8850
|
-0.101 Micromoles per liter
Standard Deviation 1.1035
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Weeks 12, 24 and 52Population: ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected to analyze the chemistry parameters: calcium, glucose, potassium, sodium and urea. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value.
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 mcg
n=47 Participants
Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants received salbutamol via metered-dose inhaler as a rescue medication during the study.
|
FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg
n=9 Participants
Participants were administered FF/UMEC/VI 100/62.5/25 mcg via ELLIPTA once daily in the morning for 24 weeks. Participants with inadequate asthma control as assessed by Asthma Control Questionnaire-7 (ACQ-7) (i.e. ACQ score \>0.75) could be switched treatment from FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg at Week 24 of the treatment period based on the ACQ-7. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.
|
FF/UMEC/VI 200/62.5/25 mcg
n=55 Participants
Participants received FF/UMEC/VI 200/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.
|
|---|---|---|---|
|
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Urea
Calcium: Week 12, n=47,9,55
|
0.0021 Millimoles per liter
Standard Deviation 0.07464
|
-0.0083 Millimoles per liter
Standard Deviation 0.08461
|
-0.0245 Millimoles per liter
Standard Deviation 0.23525
|
|
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Urea
Calcium: Week 24, n=46,9,52
|
-0.0016 Millimoles per liter
Standard Deviation 0.06805
|
-0.0055 Millimoles per liter
Standard Deviation 0.12399
|
0.0043 Millimoles per liter
Standard Deviation 0.07586
|
|
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Urea
Glucose: Week 12, n=47,9,55
|
0.0343 Millimoles per liter
Standard Deviation 0.90775
|
-0.0370 Millimoles per liter
Standard Deviation 0.58286
|
0.1605 Millimoles per liter
Standard Deviation 0.82194
|
|
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Urea
Sodium: Week 12, n=47,9,55
|
-0.2 Millimoles per liter
Standard Deviation 1.77
|
-0.3 Millimoles per liter
Standard Deviation 2.00
|
-0.1 Millimoles per liter
Standard Deviation 2.13
|
|
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Urea
Sodium: Week 24, n=46,9,52
|
-0.5 Millimoles per liter
Standard Deviation 1.81
|
-1.0 Millimoles per liter
Standard Deviation 1.80
|
-0.3 Millimoles per liter
Standard Deviation 1.89
|
|
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Urea
Urea: Week 52, n=46,8,51
|
-0.2398 Millimoles per liter
Standard Deviation 1.50149
|
-0.4641 Millimoles per liter
Standard Deviation 1.28392
|
-0.0224 Millimoles per liter
Standard Deviation 1.17972
|
|
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Urea
Glucose: Week 52, n=46,8,51
|
0.0567 Millimoles per liter
Standard Deviation 0.78708
|
0.1804 Millimoles per liter
Standard Deviation 0.46514
|
0.1099 Millimoles per liter
Standard Deviation 0.66570
|
|
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Urea
Potassium: Week 12, n=47,9,55
|
-0.01 Millimoles per liter
Standard Deviation 0.326
|
-0.07 Millimoles per liter
Standard Deviation 0.206
|
-0.04 Millimoles per liter
Standard Deviation 0.301
|
|
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Urea
Potassium: Week 24, n=46,9,52
|
-0.01 Millimoles per liter
Standard Deviation 0.308
|
0.07 Millimoles per liter
Standard Deviation 0.357
|
-0.06 Millimoles per liter
Standard Deviation 0.306
|
|
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Urea
Potassium: Week 52, n=46,8,51
|
0.03 Millimoles per liter
Standard Deviation 0.293
|
0.04 Millimoles per liter
Standard Deviation 0.346
|
0.03 Millimoles per liter
Standard Deviation 0.300
|
|
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Urea
Sodium: Week 52, n=46,8,51
|
-0.4 Millimoles per liter
Standard Deviation 2.13
|
-0.8 Millimoles per liter
Standard Deviation 1.83
|
-0.2 Millimoles per liter
Standard Deviation 2.28
|
|
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Urea
Urea: Week 12, n=47,9,55
|
-0.1162 Millimoles per liter
Standard Deviation 1.16663
|
-0.9282 Millimoles per liter
Standard Deviation 1.68737
|
0.1889 Millimoles per liter
Standard Deviation 1.26748
|
|
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Urea
Urea: Week 24, n=46,9,52
|
-0.5301 Millimoles per liter
Standard Deviation 1.16959
|
-1.3328 Millimoles per liter
Standard Deviation 1.64540
|
-0.2018 Millimoles per liter
Standard Deviation 1.01357
|
|
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Urea
Calcium: Week 52, n=46,8,51
|
0.0125 Millimoles per liter
Standard Deviation 0.07815
|
0.0000 Millimoles per liter
Standard Deviation 0.09335
|
0.0313 Millimoles per liter
Standard Deviation 0.06560
|
|
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Urea
Glucose: Week 24, n=46,9,52
|
0.1255 Millimoles per liter
Standard Deviation 0.68761
|
0.0247 Millimoles per liter
Standard Deviation 0.40136
|
0.2701 Millimoles per liter
Standard Deviation 0.79361
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and up to Week 52Population: ITT Population.
Urine samples were collected for analysis of presence of occult blood and protein in urine using dipstick method. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of occult blood and protein can be read as Trace, 1+, 2+ and 3+ indicating proportional concentrations in the urine sample. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 mcg
n=47 Participants
Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants received salbutamol via metered-dose inhaler as a rescue medication during the study.
|
FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg
n=9 Participants
Participants were administered FF/UMEC/VI 100/62.5/25 mcg via ELLIPTA once daily in the morning for 24 weeks. Participants with inadequate asthma control as assessed by Asthma Control Questionnaire-7 (ACQ-7) (i.e. ACQ score \>0.75) could be switched treatment from FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg at Week 24 of the treatment period based on the ACQ-7. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.
|
FF/UMEC/VI 200/62.5/25 mcg
n=55 Participants
Participants received FF/UMEC/VI 200/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.
|
|---|---|---|---|
|
Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline
Occult Blood; Increase to 3+
|
3 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline
Protein; No Change/Decreased
|
32 Participants
|
7 Participants
|
34 Participants
|
|
Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline
Occult Blood; No Change/Decreased
|
39 Participants
|
7 Participants
|
44 Participants
|
|
Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline
Occult Blood; Increase to Trace
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline
Protein; Increase to Trace
|
10 Participants
|
1 Participants
|
14 Participants
|
|
Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline
Protein; Increase to 1+
|
5 Participants
|
0 Participants
|
5 Participants
|
|
Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline
Protein; Increase to 2+
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline
Protein; Increase to 3+
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline
Occult Blood; Increase to 1+
|
2 Participants
|
0 Participants
|
4 Participants
|
|
Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline
Occult Blood; Increase to 2+
|
2 Participants
|
1 Participants
|
3 Participants
|
Adverse Events
FF/UMEC/VI 100/62.5/25 mcg
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
FF/UMEC/VI 200/62.5/25 mcg
Serious events: 2 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FF/UMEC/VI 100/62.5/25 mcg
n=47 participants at risk
Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants received salbutamol via metered-dose inhaler as a rescue medication during the study.
|
FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg
n=9 participants at risk
Participants were administered FF/UMEC/VI 100/62.5/25 mcg via ELLIPTA once daily in the morning for 24 weeks. Participants with inadequate asthma control as assessed by Asthma Control Questionnaire-7 (ACQ-7) (i.e. ACQ score \>0.75) could be switched treatment from FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg at Week 24 of the treatment period based on the ACQ-7. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.
|
FF/UMEC/VI 200/62.5/25 mcg
n=55 participants at risk
Participants received FF/UMEC/VI 200/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.
|
|---|---|---|---|
|
Immune system disorders
Eosinophilic granulomatosis with polyangiitis
|
0.00%
0/47 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
1.8%
1/55 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
|
Infections and infestations
Appendicitis
|
2.1%
1/47 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
0.00%
0/55 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.00%
0/47 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
1.8%
1/55 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
Other adverse events
| Measure |
FF/UMEC/VI 100/62.5/25 mcg
n=47 participants at risk
Participants received FF/UMEC/VI 100/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants received salbutamol via metered-dose inhaler as a rescue medication during the study.
|
FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg
n=9 participants at risk
Participants were administered FF/UMEC/VI 100/62.5/25 mcg via ELLIPTA once daily in the morning for 24 weeks. Participants with inadequate asthma control as assessed by Asthma Control Questionnaire-7 (ACQ-7) (i.e. ACQ score \>0.75) could be switched treatment from FF/UMEC/VI 100/62.5/25 mcg to FF/UMEC/VI 200/62.5/25 mcg at Week 24 of the treatment period based on the ACQ-7. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.
|
FF/UMEC/VI 200/62.5/25 mcg
n=55 participants at risk
Participants received FF/UMEC/VI 200/62.5/25 mcg inhalation powder via ELLIPTA once daily in the morning for 52 weeks. Participants were administered salbutamol via metered-dose inhaler as a rescue medication.
|
|---|---|---|---|
|
Infections and infestations
Vaginal infection
|
0.00%
0/47 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
11.1%
1/9 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
0.00%
0/55 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/47 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
11.1%
1/9 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
0.00%
0/55 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
|
Infections and infestations
Nasopharyngitis
|
27.7%
13/47 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
22.2%
2/9 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
32.7%
18/55 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
|
Infections and infestations
Pharyngitis
|
10.6%
5/47 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
22.2%
2/9 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
7.3%
4/55 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
|
Infections and infestations
Bronchitis
|
8.5%
4/47 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
22.2%
2/9 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
7.3%
4/55 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
|
Infections and infestations
Influenza
|
6.4%
3/47 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
11.1%
1/9 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
9.1%
5/55 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
|
Infections and infestations
Gastroenteritis
|
4.3%
2/47 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
11.1%
1/9 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
3.6%
2/55 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
|
Infections and infestations
Rhinitis
|
4.3%
2/47 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
5.5%
3/55 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
|
Infections and infestations
Acute sinusitis
|
2.1%
1/47 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
11.1%
1/9 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
3.6%
2/55 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
|
Infections and infestations
Chronic sinusitis
|
2.1%
1/47 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
11.1%
1/9 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
0.00%
0/55 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/47 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
11.1%
1/9 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
0.00%
0/55 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/47 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
11.1%
1/9 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
0.00%
0/55 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/47 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
11.1%
1/9 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
0.00%
0/55 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
|
Nervous system disorders
Dysgeusia
|
6.4%
3/47 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
22.2%
2/9 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
10.9%
6/55 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
4.3%
2/47 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
5.5%
3/55 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
4.3%
2/47 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
5.5%
3/55 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.1%
1/47 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
11.1%
1/9 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
9.1%
5/55 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/47 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
11.1%
1/9 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
1.8%
1/55 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
|
Investigations
Weight decreased
|
0.00%
0/47 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
11.1%
1/9 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
1.8%
1/55 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
|
Investigations
Eosinophil count increased
|
0.00%
0/47 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
11.1%
1/9 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
0.00%
0/55 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
|
Investigations
Low density lipoprotein increased
|
0.00%
0/47 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
11.1%
1/9 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
0.00%
0/55 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
|
Gastrointestinal disorders
Chronic gastritis
|
2.1%
1/47 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
11.1%
1/9 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
1.8%
1/55 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/47 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
11.1%
1/9 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
0.00%
0/55 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/47 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
11.1%
1/9 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
0.00%
0/55 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
|
Ear and labyrinth disorders
Eustachian tube stenosis
|
0.00%
0/47 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
11.1%
1/9 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
0.00%
0/55 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
|
Eye disorders
Pterygium
|
0.00%
0/47 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
11.1%
1/9 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
0.00%
0/55 • Non-SAEs and SAEs were collected from Day 1 up to Week 52
ITT Population comprised of all participants who received at least one dose of study treatment in the treatment period.
|
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