Trial Outcomes & Findings for Evaluate the Safety, Efficacy and Dose Response of GSK573719 in Combination With Fluticasone Furoate in Subjects With Asthma (NCT NCT01573624)
NCT ID: NCT01573624
Last Updated: 2017-10-06
Results Overview
FEV1 is a lung function measure defined as the maximal amount of air that can be forcefully exhaled in one second. Highest FEV1 from the 3 acceptable spirometric efforts were recorded between 5.00 ante meridiem (AM) and 11.00 AM after withholding albuterol (salbutamol) at all visits for at least 4 hours. Baseline was defined as the pre- dose FEV1 value obtained on Day 1 and trough was defined as FEV1 value obtained 24 hours after morning dosing on Day 14 of each treatment period. Change from baseline value for each participant in each treatment period was the difference between the observed on-treatment value obtained 24 hours after morning dosing on Day 14 and the baseline value for that period. Slope-intercept on log dose model was used to predict trough FEV1 change from baseline for each of the FF+UMEC doses adjusted by FF 100 mcg alone. Mean value for the expected response and associated 95% confidence interval (CI) in change from baseline trough FEV1 is presented.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
421 participants
Primary outcome timeframe
Baseline (Day 1) and Day 15 of each treatment period
Results posted on
2017-10-06
Participant Flow
The study was conducted across 33 centres of 5 countries from 03 April 2012 to 04 February 2013 in adults aged 18 to 50 years with persistent asthma. Participants were randomized for 3 treatment periods of 2 weeks each.
A total of 706 participants were screened for this study designed in 3 period crossover, incomplete block manner; 523 participants entered 2-week open label run-in period where they received fluticasone furoate (FF) 100 micrograms (mcg) dry powder inhalation once daily. A total of 421 participants were randomized to double-blind treatment period.
Participant milestones
| Measure |
FF 100 mcg First
Participants received a dose of FF 100 mcg via a dry powder inhaler (DPI) once daily in the morning for 14 days during the first treatment period of the 3 treatment periods as per their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol metered-dose inhaler (MDI) was provided as the rescue medication.
|
FF 100 mcg + UMEC 15.6 mcg First
Participants received fixed dose of FF 100 mcg and umeclidinium bromide (UMEC) 15.6 mcg via a DPI once daily in the morning for 14 days during the first treatment period of the 3 treatment periods as per their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
FF 100 mcg + UMEC 31.25 mcg First
Participants received fixed dose of FF 100 mcg and UMEC 31.25 mcg via a DPI once daily in the morning for 14 days during the first treatment period of the 3 treatment periods as per their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
FF 100 mcg + UMEC 62.5 mcg First
Participants received fixed dose of FF 100 mcg and UMEC 62.5 mcg via a DPI once daily in the morning for 14 days during the first treatment period of the 3 treatment periods as per their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
FF 100 mcg + UMEC 125 mcg First
Participants received fixed dose of FF 100 mcg and UMEC 125 mcg via a DPI once daily in the morning for 14 days during the first treatment period of the 3 treatment periods as per their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
FF 100 mcg + UMEC 250 mcg First
Participants received fixed dose of FF 100 mcg and UMEC 250 mcg via a DPI once daily in the morning for 14 days during the first treatment period of the 3 treatment periods as per their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
FF 100 mcg + VI 25 mcg First
Participants received fixed dose of FF 100 mcg and vilanterol (VI) 25 mcg via a DPI once daily in the morning for 14 days during the first treatment period of the 3 treatment periods as per their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
|---|---|---|---|---|---|---|---|
|
Period 1 : Treatment Period 1 (14 Days)
STARTED
|
64
|
62
|
60
|
63
|
58
|
55
|
59
|
|
Period 1 : Treatment Period 1 (14 Days)
COMPLETED
|
58
|
59
|
51
|
61
|
56
|
51
|
57
|
|
Period 1 : Treatment Period 1 (14 Days)
NOT COMPLETED
|
6
|
3
|
9
|
2
|
2
|
4
|
2
|
|
Period 2 : Washout Period 1 (12-14 Days)
STARTED
|
58
|
59
|
51
|
61
|
56
|
51
|
57
|
|
Period 2 : Washout Period 1 (12-14 Days)
COMPLETED
|
57
|
58
|
48
|
56
|
56
|
48
|
55
|
|
Period 2 : Washout Period 1 (12-14 Days)
NOT COMPLETED
|
1
|
1
|
3
|
5
|
0
|
3
|
2
|
|
Period 3 : Treatment Period 2 (14 Days)
STARTED
|
57
|
58
|
48
|
56
|
56
|
48
|
55
|
|
Period 3 : Treatment Period 2 (14 Days)
COMPLETED
|
50
|
52
|
45
|
55
|
53
|
43
|
55
|
|
Period 3 : Treatment Period 2 (14 Days)
NOT COMPLETED
|
7
|
6
|
3
|
1
|
3
|
5
|
0
|
|
Period 4 : Washout Period 2 (12-14 Days)
STARTED
|
50
|
52
|
45
|
55
|
53
|
43
|
55
|
|
Period 4 : Washout Period 2 (12-14 Days)
COMPLETED
|
49
|
48
|
43
|
53
|
52
|
41
|
52
|
|
Period 4 : Washout Period 2 (12-14 Days)
NOT COMPLETED
|
1
|
4
|
2
|
2
|
1
|
2
|
3
|
|
Period 5 : Treatment Period 3 (14 Days)
STARTED
|
49
|
48
|
43
|
53
|
52
|
41
|
52
|
|
Period 5 : Treatment Period 3 (14 Days)
COMPLETED
|
46
|
47
|
43
|
53
|
51
|
39
|
48
|
|
Period 5 : Treatment Period 3 (14 Days)
NOT COMPLETED
|
3
|
1
|
0
|
0
|
1
|
2
|
4
|
|
Period 6 : Follow-up Period (7 Days)
STARTED
|
46
|
47
|
43
|
53
|
51
|
39
|
48
|
|
Period 6 : Follow-up Period (7 Days)
COMPLETED
|
45
|
47
|
43
|
53
|
49
|
38
|
48
|
|
Period 6 : Follow-up Period (7 Days)
NOT COMPLETED
|
1
|
0
|
0
|
0
|
2
|
1
|
0
|
Reasons for withdrawal
| Measure |
FF 100 mcg First
Participants received a dose of FF 100 mcg via a dry powder inhaler (DPI) once daily in the morning for 14 days during the first treatment period of the 3 treatment periods as per their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol metered-dose inhaler (MDI) was provided as the rescue medication.
|
FF 100 mcg + UMEC 15.6 mcg First
Participants received fixed dose of FF 100 mcg and umeclidinium bromide (UMEC) 15.6 mcg via a DPI once daily in the morning for 14 days during the first treatment period of the 3 treatment periods as per their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
FF 100 mcg + UMEC 31.25 mcg First
Participants received fixed dose of FF 100 mcg and UMEC 31.25 mcg via a DPI once daily in the morning for 14 days during the first treatment period of the 3 treatment periods as per their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
FF 100 mcg + UMEC 62.5 mcg First
Participants received fixed dose of FF 100 mcg and UMEC 62.5 mcg via a DPI once daily in the morning for 14 days during the first treatment period of the 3 treatment periods as per their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
FF 100 mcg + UMEC 125 mcg First
Participants received fixed dose of FF 100 mcg and UMEC 125 mcg via a DPI once daily in the morning for 14 days during the first treatment period of the 3 treatment periods as per their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
FF 100 mcg + UMEC 250 mcg First
Participants received fixed dose of FF 100 mcg and UMEC 250 mcg via a DPI once daily in the morning for 14 days during the first treatment period of the 3 treatment periods as per their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
FF 100 mcg + VI 25 mcg First
Participants received fixed dose of FF 100 mcg and vilanterol (VI) 25 mcg via a DPI once daily in the morning for 14 days during the first treatment period of the 3 treatment periods as per their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
|---|---|---|---|---|---|---|---|
|
Period 2 : Washout Period 1 (12-14 Days)
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Period 1 : Treatment Period 1 (14 Days)
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
|
Period 1 : Treatment Period 1 (14 Days)
Lack of Efficacy
|
4
|
3
|
6
|
1
|
2
|
0
|
1
|
|
Period 1 : Treatment Period 1 (14 Days)
Protocol Violation
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 1 : Treatment Period 1 (14 Days)
Withdrawal by Subject
|
1
|
0
|
1
|
0
|
0
|
2
|
0
|
|
Period 1 : Treatment Period 1 (14 Days)
Protocol-defined stopping criteria
|
0
|
0
|
1
|
1
|
0
|
1
|
1
|
|
Period 2 : Washout Period 1 (12-14 Days)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Period 2 : Washout Period 1 (12-14 Days)
Lack of Efficacy
|
0
|
1
|
0
|
1
|
0
|
0
|
1
|
|
Period 2 : Washout Period 1 (12-14 Days)
Protocol Violation
|
1
|
0
|
2
|
1
|
0
|
0
|
0
|
|
Period 2 : Washout Period 1 (12-14 Days)
Withdrawal by Subject
|
0
|
0
|
0
|
2
|
0
|
0
|
1
|
|
Period 2 : Washout Period 1 (12-14 Days)
Protocol-defined stopping criteria
|
0
|
0
|
1
|
1
|
0
|
1
|
0
|
|
Period 3 : Treatment Period 2 (14 Days)
Lack of Efficacy
|
5
|
4
|
2
|
1
|
3
|
2
|
0
|
|
Period 3 : Treatment Period 2 (14 Days)
Protocol Violation
|
0
|
1
|
0
|
0
|
0
|
2
|
0
|
|
Period 3 : Treatment Period 2 (14 Days)
Physician Decision
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 3 : Treatment Period 2 (14 Days)
Withdrawal by Subject
|
0
|
1
|
1
|
0
|
0
|
1
|
0
|
|
Period 3 : Treatment Period 2 (14 Days)
Protocol-defined stopping criteria
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 4 : Washout Period 2 (12-14 Days)
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Period 4 : Washout Period 2 (12-14 Days)
Lack of Efficacy
|
0
|
1
|
1
|
1
|
1
|
0
|
1
|
|
Period 4 : Washout Period 2 (12-14 Days)
Protocol Violation
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Period 4 : Washout Period 2 (12-14 Days)
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Period 4 : Washout Period 2 (12-14 Days)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Period 4 : Washout Period 2 (12-14 Days)
Protocol-defined stopping criteria
|
0
|
1
|
1
|
1
|
0
|
1
|
0
|
|
Period 5 : Treatment Period 3 (14 Days)
Lack of Efficacy
|
2
|
0
|
0
|
0
|
1
|
1
|
4
|
|
Period 5 : Treatment Period 3 (14 Days)
Protocol Violation
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
|
Period 5 : Treatment Period 3 (14 Days)
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 6 : Follow-up Period (7 Days)
Adverse Event
|
0
|
0
|
0
|
0
|
2
|
1
|
0
|
|
Period 6 : Follow-up Period (7 Days)
Protocol Violation
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Evaluate the Safety, Efficacy and Dose Response of GSK573719 in Combination With Fluticasone Furoate in Subjects With Asthma
Baseline characteristics by cohort
| Measure |
All Treatments Combined
n=421 Participants
The participants received 3 of the 7 possible treatments during the 3 double blind treatment periods. Participants received study treatments in a crossover manner according to their randomization sequence. The 7 treatment regimens were, FF 100 mcg, FF 100 mcg + UMEC 15.6 mcg, FF 100 mcg + UMEC 31.25 mcg, FF 100 mcg + UMEC 62.5 mcg, FF 100 mcg + UMEC 125 mcg, FF 100 mcg + UMEC 250 mcg and FF 100 mcg + VI 25 mcg. The study treatments were administered via a DPI taken once daily in the morning for 14 days during each study period. The treatment periods were separated by 2 washout periods of 12-14 days each. During the two week run-in period and during the two washout period, participants were administered open-label FF 100 mcg once daily in the morning via a DPI. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
|---|---|
|
Age, Continuous
|
47.5 Years
STANDARD_DEVIATION 13.84 • n=5 Participants
|
|
Sex: Female, Male
Female
|
289 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
132 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
367 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and Day 15 of each treatment periodPopulation: The primary endpoint was analyzed using Intent -to -Treat (ITT) Population defined as all participants randomized to treatment and who received at least one dose of study medication. Only those participants with data available at the indicated time points were analyzed.
FEV1 is a lung function measure defined as the maximal amount of air that can be forcefully exhaled in one second. Highest FEV1 from the 3 acceptable spirometric efforts were recorded between 5.00 ante meridiem (AM) and 11.00 AM after withholding albuterol (salbutamol) at all visits for at least 4 hours. Baseline was defined as the pre- dose FEV1 value obtained on Day 1 and trough was defined as FEV1 value obtained 24 hours after morning dosing on Day 14 of each treatment period. Change from baseline value for each participant in each treatment period was the difference between the observed on-treatment value obtained 24 hours after morning dosing on Day 14 and the baseline value for that period. Slope-intercept on log dose model was used to predict trough FEV1 change from baseline for each of the FF+UMEC doses adjusted by FF 100 mcg alone. Mean value for the expected response and associated 95% confidence interval (CI) in change from baseline trough FEV1 is presented.
Outcome measures
| Measure |
FF 100 mcg + UMEC 15.6 mcg
n=154 Participants
Participants received fixed dose of FF 100 mcg and UMEC 15.6 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
FF 100 mcg + UMEC 31.25 mcg
n=146 Participants
Participants received fixed dose of FF 100 mcg and UMEC 31.25 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
FF 100 mcg + UMEC 62.5 mcg
n=150 Participants
Participants received fixed dose of FF 100 mcg and UMEC 62.5 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
FF 100 mcg + UMEC 125 mcg
n=155 Participants
Participants received fixed dose of FF 100 mcg and UMEC 125 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
FF 100 mcg + UMEC 250 mcg
n=150 Participants
Participants received fixed dose of FF 100 mcg and UMEC 250 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
FF 100 mcg + UMEC 250 mcg
Participants received fixed dose of FF 100 mcg and UMEC 250 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
FF 100 mcg + VI 25 mcg
Participants received fixed dose of FF 100 mcg and VI 25 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
|---|---|---|---|---|---|---|---|
|
Model Predicted Change From Baseline Trough Force Expiratory Volume in 1 Second (FEV1)
|
0.0260 Litres (L)
Interval -0.0098 to 0.0611
|
0.0320 Litres (L)
Interval -0.0036 to 0.0679
|
0.0385 Litres (L)
Interval -0.0011 to 0.0745
|
0.0444 Litres (L)
Interval 0.0067 to 0.0813
|
0.0510 Litres (L)
Interval 0.0139 to 0.0873
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and Day 15 of each treatment periodPopulation: ITT Population. Only those participants with data available at the indicated time points were analyzed.
FEV1 is a lung function measure defined as the maximal amount of air that can be forcefully exhaled in one second. Highest FEV1 from the 3 acceptable spirometric efforts were recorded between 5.00 AM and 11.00 AM after withholding albuterol (salbutamol) at all visits for at least 4 hours. Baseline was defined as the pre- dose FEV1 value obtained on Day 1 and trough was defined as FEV1 value obtained 24 hours after morning dosing on Day 14 of each treatment period. Change from baseline value for each participant in each treatment period was the difference between the observed on-treatment value obtained 24 hours after morning dosing on Day 14 and the baseline value for that period. Data is presented as percentage chance that FF 100 mcg alone corrected change from baseline trough FEV1 response would exceed a target response of 50 mL, 75 mL, 100 mL and 150 mL by doses of UMEC combined with FF 100 mcg.
Outcome measures
| Measure |
FF 100 mcg + UMEC 15.6 mcg
n=154 Participants
Participants received fixed dose of FF 100 mcg and UMEC 15.6 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
FF 100 mcg + UMEC 31.25 mcg
n=146 Participants
Participants received fixed dose of FF 100 mcg and UMEC 31.25 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
FF 100 mcg + UMEC 62.5 mcg
n=150 Participants
Participants received fixed dose of FF 100 mcg and UMEC 62.5 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
FF 100 mcg + UMEC 125 mcg
n=155 Participants
Participants received fixed dose of FF 100 mcg and UMEC 125 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
FF 100 mcg + UMEC 250 mcg
n=150 Participants
Participants received fixed dose of FF 100 mcg and UMEC 250 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
FF 100 mcg + UMEC 250 mcg
Participants received fixed dose of FF 100 mcg and UMEC 250 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
FF 100 mcg + VI 25 mcg
Participants received fixed dose of FF 100 mcg and VI 25 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Chance That FF 100 mcg Alone Corrected Change From Baseline FEV1 Response Would Exceed a Target Response by Dose of UMEC Combined With FF 100 mcg
Target response of 50 mL
|
9 Percentage chance
|
17 Percentage chance
|
27 Percentage chance
|
37 Percentage chance
|
52 Percentage chance
|
—
|
—
|
|
Percentage of Chance That FF 100 mcg Alone Corrected Change From Baseline FEV1 Response Would Exceed a Target Response by Dose of UMEC Combined With FF 100 mcg
Target response of 75 mL
|
0.5 Percentage chance
|
1 Percentage chance
|
2 Percentage chance
|
5 Percentage chance
|
10 Percentage chance
|
—
|
—
|
|
Percentage of Chance That FF 100 mcg Alone Corrected Change From Baseline FEV1 Response Would Exceed a Target Response by Dose of UMEC Combined With FF 100 mcg
Target response of 100 mL
|
0 Percentage chance
|
0 Percentage chance
|
0 Percentage chance
|
0.2 Percentage chance
|
0.2 Percentage chance
|
—
|
—
|
|
Percentage of Chance That FF 100 mcg Alone Corrected Change From Baseline FEV1 Response Would Exceed a Target Response by Dose of UMEC Combined With FF 100 mcg
Target response of 150 mL
|
0 Percentage chance
|
0 Percentage chance
|
0 Percentage chance
|
0 Percentage chance
|
0 Percentage chance
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and Day 15 of each treatment periodPopulation: ITT Population. Only those participants with data available at the indicated time points were analyzed.
FEV1 is a lung function measure defined as the maximal amount of air that can be forcefully exhaled in one second. The highest FEV1 from the 3 acceptable spirometric efforts were recorded between 5.00 AM and 11.00 AM after withholding albuterol (salbutamol) at all visits for at least 4 hours. Baseline was defined as the pre- dose FEV1 value obtained on Day 1 and trough was defined as the FEV1 value obtained 24 hours after morning dosing on Day 14 of each treatment period. The change from baseline value for each participant in each treatment period was the difference between the observed on-treatment value obtained 24 hours after morning dosing on Day 14 and the baseline value for that period. Analysis was done using a mixed model, including treatment, period, period baseline FEV1, and mean baseline FEV1 as fixed effects and participant as a random effect. A post hoc analysis was performed to confirm nullification of carry over effect of UMEC.
Outcome measures
| Measure |
FF 100 mcg + UMEC 15.6 mcg
n=146 Participants
Participants received fixed dose of FF 100 mcg and UMEC 15.6 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
FF 100 mcg + UMEC 31.25 mcg
n=154 Participants
Participants received fixed dose of FF 100 mcg and UMEC 31.25 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
FF 100 mcg + UMEC 62.5 mcg
n=146 Participants
Participants received fixed dose of FF 100 mcg and UMEC 62.5 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
FF 100 mcg + UMEC 125 mcg
n=150 Participants
Participants received fixed dose of FF 100 mcg and UMEC 125 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
FF 100 mcg + UMEC 250 mcg
n=155 Participants
Participants received fixed dose of FF 100 mcg and UMEC 250 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
FF 100 mcg + UMEC 250 mcg
n=150 Participants
Participants received fixed dose of FF 100 mcg and UMEC 250 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
FF 100 mcg + VI 25 mcg
n=147 Participants
Participants received fixed dose of FF 100 mcg and VI 25 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Trough FEV1 on Day 15 of Each of the 3 Treatment Periods
|
0.120 Litres (L)
Standard Error 0.0175
|
0.145 Litres (L)
Standard Error 0.0170
|
0.152 Litres (L)
Standard Error 0.0174
|
0.145 Litres (L)
Standard Error 0.0172
|
0.174 Litres (L)
Standard Error 0.0170
|
0.175 Litres (L)
Standard Error 0.0172
|
0.198 Litres (L)
Standard Error 0.0174
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and last 7 days of each treatment periodPopulation: ITT Population. Only those participants with data available at the indicated time points were analyzed.
PEF is a measure of lung function and measures how fast a person can breathe out. Morning PEF was measured pre-dose and pre- rescue bronchodilator use with an electronic Peak Flow Meter. Participants were issued an electronic diary (eDiary) for daily use throughout the study and instructed on how to complete it. Best of 3 attempts were recorded in eDiary. Mean change from baseline was calculated where, baseline was defined as the measurement from (Week 0), includes Day 1 and six days immediately preceding Day 1 for each treatment period. The change from baseline values for each participant in each treatment period were differences between on-treatment week (last 7 days of each treatment period) values and baseline week. Analysis was done using a mixed model, including treatment, period, period baseline morning PEF and mean baseline morning PEF as fixed effects and participant as a random effect. A post hoc analysis was performed to confirm nullification of carry over effect of UMEC.
Outcome measures
| Measure |
FF 100 mcg + UMEC 15.6 mcg
n=159 Participants
Participants received fixed dose of FF 100 mcg and UMEC 15.6 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
FF 100 mcg + UMEC 31.25 mcg
n=159 Participants
Participants received fixed dose of FF 100 mcg and UMEC 31.25 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
FF 100 mcg + UMEC 62.5 mcg
n=156 Participants
Participants received fixed dose of FF 100 mcg and UMEC 62.5 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
FF 100 mcg + UMEC 125 mcg
n=155 Participants
Participants received fixed dose of FF 100 mcg and UMEC 125 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
FF 100 mcg + UMEC 250 mcg
n=158 Participants
Participants received fixed dose of FF 100 mcg and UMEC 250 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
FF 100 mcg + UMEC 250 mcg
n=159 Participants
Participants received fixed dose of FF 100 mcg and UMEC 250 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
FF 100 mcg + VI 25 mcg
n=156 Participants
Participants received fixed dose of FF 100 mcg and VI 25 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Daily Morning (Pre-dose and Pre-rescue Bronchodilator) Peak Expiratory Flow (PEF) of Each Treatment Period
|
-2.9 Litres per min (L/min)
Standard Error 2.44
|
13.0 Litres per min (L/min)
Standard Error 2.44
|
14.5 Litres per min (L/min)
Standard Error 2.46
|
15.7 Litres per min (L/min)
Standard Error 2.47
|
20.0 Litres per min (L/min)
Standard Error 2.44
|
19.0 Litres per min (L/min)
Standard Error 2.44
|
24.1 Litres per min (L/min)
Standard Error 2.46
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and last 7 days of each treatment periodPopulation: ITT Population. Only those participants with data available at the indicated time points were analyzed.
PEF is a measure of lung function and measures how fast a person can breathe out. Evening PEF was measured pre-dose and pre-rescue bronchodilator use with an electronic Peak Flow Meter. Participants were issued an electronic diary (eDiary) for daily use throughout the study and instructed on how to complete it. Best of 3 attempts were recorded in eDiary. Mean change from baseline was calculated where, baseline was defined as the measurement from (Week 0), includes Day 1 and seven days immediately preceding Day 1 for each treatment period. The change from baseline values for each participant in each treatment period were differences between on-treatment week (last 7 days of each treatment period) values and baseline week. Analysis was done using a mixed model, including treatment, period, period baseline evening PEF and mean baseline evening PEF as fixed effects and participant as a random effect. A post hoc analysis was performed to confirm nullification of carry over effect of UMEC.
Outcome measures
| Measure |
FF 100 mcg + UMEC 15.6 mcg
n=160 Participants
Participants received fixed dose of FF 100 mcg and UMEC 15.6 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
FF 100 mcg + UMEC 31.25 mcg
n=157 Participants
Participants received fixed dose of FF 100 mcg and UMEC 31.25 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
FF 100 mcg + UMEC 62.5 mcg
n=156 Participants
Participants received fixed dose of FF 100 mcg and UMEC 62.5 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
FF 100 mcg + UMEC 125 mcg
n=154 Participants
Participants received fixed dose of FF 100 mcg and UMEC 125 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
FF 100 mcg + UMEC 250 mcg
n=157 Participants
Participants received fixed dose of FF 100 mcg and UMEC 250 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
FF 100 mcg + UMEC 250 mcg
n=157 Participants
Participants received fixed dose of FF 100 mcg and UMEC 250 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
FF 100 mcg + VI 25 mcg
n=153 Participants
Participants received fixed dose of FF 100 mcg and VI 25 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Daily Evening (Pre-dose and Pre-rescue Bronchodilator) PEF of Each Treatment Period
|
-5.2 L/min
Standard Error 2.51
|
11.1 L/min
Standard Error 2.53
|
12.1 L/min
Standard Error 2.54
|
16.0 L/min
Standard Error 2.56
|
23.7 L/min
Standard Error 2.52
|
17.7 L/min
Standard Error 2.52
|
21.4 L/min
Standard Error 2.58
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and last 7 days of each treatment periodPopulation: ITT Population. Only those participants with data available at the indicated time points were analyzed.
Short-Acting Beta2-Agonists albuterol/salbutamol was provided to participants as rescue medication, to use in morning and evening. Participants recorded number of puffs of salbutamol MDI used in last 24 hours (sum of night time and day time puffs) daily for relief of symptoms in eDiary. Mean change from baseline was calculated where, baseline was defined as measurement from (Week 0), includes Day 1 and six days immediately preceding Day 1 (for night time puffs) and seven days (for day time puffs) for each treatment period. Change from baseline values for each participant in each treatment period were differences between on-treatment week (last 7 days of each treatment period) values and the baseline week. Analysis was done using a mixed model, including treatment, period, period baseline rescue albuterol use, and mean baseline rescue albuterol use as fixed effects and participant as random effect. A post hoc analysis was performed to confirm nullification of carry over effect of UMEC.
Outcome measures
| Measure |
FF 100 mcg + UMEC 15.6 mcg
n=158 Participants
Participants received fixed dose of FF 100 mcg and UMEC 15.6 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
FF 100 mcg + UMEC 31.25 mcg
n=151 Participants
Participants received fixed dose of FF 100 mcg and UMEC 31.25 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
FF 100 mcg + UMEC 62.5 mcg
n=152 Participants
Participants received fixed dose of FF 100 mcg and UMEC 62.5 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
FF 100 mcg + UMEC 125 mcg
n=151 Participants
Participants received fixed dose of FF 100 mcg and UMEC 125 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
FF 100 mcg + UMEC 250 mcg
n=153 Participants
Participants received fixed dose of FF 100 mcg and UMEC 250 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
FF 100 mcg + UMEC 250 mcg
n=157 Participants
Participants received fixed dose of FF 100 mcg and UMEC 250 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
FF 100 mcg + VI 25 mcg
n=151 Participants
Participants received fixed dose of FF 100 mcg and VI 25 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Rescue Albuterol/Salbutamol Use of Each Treatment Period.
|
-0.2 Number of puffs
Standard Error 0.09
|
-0.4 Number of puffs
Standard Error 0.09
|
-0.4 Number of puffs
Standard Error 0.09
|
-0.3 Number of puffs
Standard Error 0.09
|
-0.5 Number of puffs
Standard Error 0.09
|
-0.4 Number of puffs
Standard Error 0.09
|
-0.6 Number of puffs
Standard Error 0.09
|
Adverse Events
FF 100 mcg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
FF 100 mcg + UMEC 15.6 mcg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
FF 100 mcg + UMEC 31.25 mcg
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
FF 100 mcg + UMEC 62.5 mcg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
FF 100 mcg + UMEC 125 mcg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
FF 100 mcg + UMEC 250 mcg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
FF 100 mcg + VI 25 mcg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FF 100 mcg
n=187 participants at risk
Participants received a dose of FF 100 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
FF 100 mcg + UMEC 15.6 mcg
n=183 participants at risk
Participants received fixed dose of FF 100 mcg and UMEC 15.6 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
FF 100 mcg + UMEC 31.25 mcg
n=179 participants at risk
Participants received fixed dose of FF 100 mcg and UMEC 31.25 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
FF 100 mcg + UMEC 62.5 mcg
n=180 participants at risk
Participants received fixed dose of FF 100 mcg and UMEC 62.5 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
FF 100 mcg + UMEC 125 mcg
n=176 participants at risk
Participants received fixed dose of FF 100 mcg and UMEC 125 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
FF 100 mcg + UMEC 250 mcg
n=186 participants at risk
Participants received fixed dose of FF 100 mcg and UMEC 250 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
FF 100 mcg + VI 25 mcg
n=172 participants at risk
Participants received fixed dose of FF 100 mcg and VI 25 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
|---|---|---|---|---|---|---|---|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/187 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment (Visit 3) up to the follow-up (Visit 12, held 7 days from the Day 15 of treatment period 3 [Visit 11]). AE's and SAE's were reported for the treatment period only ( Visit 11 [up to Day 15 of the treatment period 3]).
ITT Population was used.
|
0.00%
0/183 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment (Visit 3) up to the follow-up (Visit 12, held 7 days from the Day 15 of treatment period 3 [Visit 11]). AE's and SAE's were reported for the treatment period only ( Visit 11 [up to Day 15 of the treatment period 3]).
ITT Population was used.
|
0.00%
0/179 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment (Visit 3) up to the follow-up (Visit 12, held 7 days from the Day 15 of treatment period 3 [Visit 11]). AE's and SAE's were reported for the treatment period only ( Visit 11 [up to Day 15 of the treatment period 3]).
ITT Population was used.
|
0.00%
0/180 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment (Visit 3) up to the follow-up (Visit 12, held 7 days from the Day 15 of treatment period 3 [Visit 11]). AE's and SAE's were reported for the treatment period only ( Visit 11 [up to Day 15 of the treatment period 3]).
ITT Population was used.
|
0.00%
0/176 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment (Visit 3) up to the follow-up (Visit 12, held 7 days from the Day 15 of treatment period 3 [Visit 11]). AE's and SAE's were reported for the treatment period only ( Visit 11 [up to Day 15 of the treatment period 3]).
ITT Population was used.
|
0.00%
0/186 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment (Visit 3) up to the follow-up (Visit 12, held 7 days from the Day 15 of treatment period 3 [Visit 11]). AE's and SAE's were reported for the treatment period only ( Visit 11 [up to Day 15 of the treatment period 3]).
ITT Population was used.
|
0.58%
1/172 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment (Visit 3) up to the follow-up (Visit 12, held 7 days from the Day 15 of treatment period 3 [Visit 11]). AE's and SAE's were reported for the treatment period only ( Visit 11 [up to Day 15 of the treatment period 3]).
ITT Population was used.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/187 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment (Visit 3) up to the follow-up (Visit 12, held 7 days from the Day 15 of treatment period 3 [Visit 11]). AE's and SAE's were reported for the treatment period only ( Visit 11 [up to Day 15 of the treatment period 3]).
ITT Population was used.
|
0.00%
0/183 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment (Visit 3) up to the follow-up (Visit 12, held 7 days from the Day 15 of treatment period 3 [Visit 11]). AE's and SAE's were reported for the treatment period only ( Visit 11 [up to Day 15 of the treatment period 3]).
ITT Population was used.
|
0.56%
1/179 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment (Visit 3) up to the follow-up (Visit 12, held 7 days from the Day 15 of treatment period 3 [Visit 11]). AE's and SAE's were reported for the treatment period only ( Visit 11 [up to Day 15 of the treatment period 3]).
ITT Population was used.
|
0.00%
0/180 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment (Visit 3) up to the follow-up (Visit 12, held 7 days from the Day 15 of treatment period 3 [Visit 11]). AE's and SAE's were reported for the treatment period only ( Visit 11 [up to Day 15 of the treatment period 3]).
ITT Population was used.
|
0.00%
0/176 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment (Visit 3) up to the follow-up (Visit 12, held 7 days from the Day 15 of treatment period 3 [Visit 11]). AE's and SAE's were reported for the treatment period only ( Visit 11 [up to Day 15 of the treatment period 3]).
ITT Population was used.
|
0.00%
0/186 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment (Visit 3) up to the follow-up (Visit 12, held 7 days from the Day 15 of treatment period 3 [Visit 11]). AE's and SAE's were reported for the treatment period only ( Visit 11 [up to Day 15 of the treatment period 3]).
ITT Population was used.
|
0.00%
0/172 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment (Visit 3) up to the follow-up (Visit 12, held 7 days from the Day 15 of treatment period 3 [Visit 11]). AE's and SAE's were reported for the treatment period only ( Visit 11 [up to Day 15 of the treatment period 3]).
ITT Population was used.
|
Other adverse events
| Measure |
FF 100 mcg
n=187 participants at risk
Participants received a dose of FF 100 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
FF 100 mcg + UMEC 15.6 mcg
n=183 participants at risk
Participants received fixed dose of FF 100 mcg and UMEC 15.6 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
FF 100 mcg + UMEC 31.25 mcg
n=179 participants at risk
Participants received fixed dose of FF 100 mcg and UMEC 31.25 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
FF 100 mcg + UMEC 62.5 mcg
n=180 participants at risk
Participants received fixed dose of FF 100 mcg and UMEC 62.5 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
FF 100 mcg + UMEC 125 mcg
n=176 participants at risk
Participants received fixed dose of FF 100 mcg and UMEC 125 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
FF 100 mcg + UMEC 250 mcg
n=186 participants at risk
Participants received fixed dose of FF 100 mcg and UMEC 250 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
FF 100 mcg + VI 25 mcg
n=172 participants at risk
Participants received fixed dose of FF 100 mcg and VI 25 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication.
|
|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
1.6%
3/187 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment (Visit 3) up to the follow-up (Visit 12, held 7 days from the Day 15 of treatment period 3 [Visit 11]). AE's and SAE's were reported for the treatment period only ( Visit 11 [up to Day 15 of the treatment period 3]).
ITT Population was used.
|
2.2%
4/183 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment (Visit 3) up to the follow-up (Visit 12, held 7 days from the Day 15 of treatment period 3 [Visit 11]). AE's and SAE's were reported for the treatment period only ( Visit 11 [up to Day 15 of the treatment period 3]).
ITT Population was used.
|
1.1%
2/179 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment (Visit 3) up to the follow-up (Visit 12, held 7 days from the Day 15 of treatment period 3 [Visit 11]). AE's and SAE's were reported for the treatment period only ( Visit 11 [up to Day 15 of the treatment period 3]).
ITT Population was used.
|
2.8%
5/180 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment (Visit 3) up to the follow-up (Visit 12, held 7 days from the Day 15 of treatment period 3 [Visit 11]). AE's and SAE's were reported for the treatment period only ( Visit 11 [up to Day 15 of the treatment period 3]).
ITT Population was used.
|
2.3%
4/176 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment (Visit 3) up to the follow-up (Visit 12, held 7 days from the Day 15 of treatment period 3 [Visit 11]). AE's and SAE's were reported for the treatment period only ( Visit 11 [up to Day 15 of the treatment period 3]).
ITT Population was used.
|
3.8%
7/186 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment (Visit 3) up to the follow-up (Visit 12, held 7 days from the Day 15 of treatment period 3 [Visit 11]). AE's and SAE's were reported for the treatment period only ( Visit 11 [up to Day 15 of the treatment period 3]).
ITT Population was used.
|
3.5%
6/172 • Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment (Visit 3) up to the follow-up (Visit 12, held 7 days from the Day 15 of treatment period 3 [Visit 11]). AE's and SAE's were reported for the treatment period only ( Visit 11 [up to Day 15 of the treatment period 3]).
ITT Population was used.
|
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