Trial Outcomes & Findings for A Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetic (PK), and Pharmacodynamic (PD) Profiles of 3 Doses of Fluticasone Furoate (FF)/GW642444 Inhalation Powder at the End of a 28-day Treatment Period in Subjects With Chronic Obstructive Pulmonary Disease (COPD) Compared to Placebo (NCT NCT01072149)
NCT ID: NCT01072149
Last Updated: 2017-11-09
Results Overview
FEV1 is defined as the amount of air that can be forcibly exhaled from the lungs in the first second of a forced exhalation. The weighted mean was calculated from pre-dose FEV1 (calculated as the mean of the -30 and -5 minute measurements) and post-dose FEV1 after 5, 15, 30, and 60 minutes and after 2, 4, 6, 8, 12, 16, 20, 22, 23, and 24 hours. Data are provided as the Least Squares Mean of the weighted mean for all three treatment periods. Analysis was performed using a mixed effects model with covariates of period treatment group, period Baseline, mean Baseline (defined as the mean of all available period Baseline FEV1 values), and period as fixed effects and participant as a random effect.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
54 participants
Primary outcome timeframe
Pre-dose and the end of each 28-day treatment period (up to 19 weeks)
Results posted on
2017-11-09
Participant Flow
Following screening and a 2-week Run-in Period, during which all participants received placebo, participants were randomized to receive 2 of the 3 strengths of study medication and placebo in the Treatment Phase of the study, which consisted of three 28-day treatment periods, each separated by a 14-day washout period.
Participant milestones
| Measure |
Sequence 1: FF/VI 50/25 µg, Placebo, FF/VI 100/25 µg
Participants self-administered fluticasone furoate/vilanterol (FF/VI) 50/25 µg, placebo, and FF/VI 100/25 µg once every day (one inhalation in the morning) for 28 days via an Investigational Product Inhaler (IPI) during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
|
Sequence 2: Placebo, FF/VI 100/25 µg, FF/VI 50/25 µg
Participants self-administered placebo, FF/VI 100/25 µg, and FF/VI 50/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
|
Sequence 3: FF/VI 200/25 µg, FF/VI 50/25 µg, Placebo
Participants self-administered FF/VI 200/25 µg, FF/VI 50/25 µg, and placebo once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
|
Sequence 4: FF/VI 200/25 µg, Placebo, and FF/VI 100/25 µg
Participants self-administered FF/VI 200/25 µg, placebo, and FF/VI 100/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
|
Sequence 5: FF/VI 50/25 µg, FF/VI 100/25 µg, Placebo
Participants self-administered FF/VI 50/25 µg, FF/VI 100/25 µg, and placebo once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
|
Sequence 6: FF/VI 50/25 µg, FF/VI 200/25 µg, Placebo
Participants self-administered FF/VI 50/25 µg, FF/VI 200/25 µg, and placebo once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
|
Sequence 7: FF/VI 200/25 µg, Placebo, FF/VI 50/25 µg
Participants self-administered FF/VI 200/25 µg, placebo, and FF/VI 50/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
|
Sequence 8: Placebo, FF/VI 50/25 µg, FF/VI 100/25 µg
Participants self-administered placebo, FF/VI 50/25 µg, and FF/VI 100/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
|
Sequence 9: FF/VI 100/25 µg, FF/VI 50/25 µg, Placebo
Participants self-administered FF/VI 100/25 µg, FF/VI 50/25 µg, and placebo once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
|
Sequence 10: FF/VI 100/25 µg, Placebo, FF/VI 50/25 µg
Participants self-administered FF/VI 100/25 µg, placebo, and FF/VI 50/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
|
Sequence 11: Placebo, FF/VI 200/25 µg, FF/VI 100/25 µg
Participants self-administered placebo, FF/VI 200/25 µg, and FF/VI 100/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
|
Sequence 12: Placebo, FF/VI 200/25 µg, FF/VI 50/25 µg
Participants self-administered placebo, FF/VI 200/25 µg, and FF/VI 50/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
|
Sequence 13: Placebo, FF/VI 100/25 µg, FF/VI 200/25 µg
Participants self-administered placebo, FF/VI 100/25 µg, and FF/VI 200/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
|
Sequence 14: FF/VI 200/25 µg, FF/VI 100/25 µg, Placebo
Participants self-administered FF/VI 200/25 µg, FF/VI 100/25 µg, and placebo once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
|
Sequence 15: FF/VI 100/25 µg, FF/VI 200/25 µg, Placebo
Participants self-administered FF/VI 100/25 µg, FF/VI 200/25 µg, and placebo once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
|
Sequence 16: Placebo, FF/VI 50/25 µg, FF/VI 200/25 µg
Participants self-administered placebo, FF/VI 50/25 µg, and FF/VI 200/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
|
Sequence 17: FF/VI 50/25 µg, Placebo, FF/VI 200/25 µg
Participants self-administered FF/VI 50/25 µg, placebo, and FF/VI 200/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
|
Sequence 18: FF/VI 100/25 µg, Placebo, FF/VI 200/25 µg
Participants self-administered FF/VI 100/25 µg, placebo, and FF/VI 200/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
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Treatment Period 1 (28 Days)
STARTED
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Treatment Period 1 (28 Days)
COMPLETED
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Treatment Period 1 (28 Days)
NOT COMPLETED
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Washout Period 1 (14 Days)
STARTED
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Washout Period 1 (14 Days)
COMPLETED
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Washout Period 1 (14 Days)
NOT COMPLETED
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Treatment Period 2 (28 Days)
STARTED
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Treatment Period 2 (28 Days)
COMPLETED
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Treatment Period 2 (28 Days)
NOT COMPLETED
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Washout Period 2 (14 Days)
STARTED
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Washout Period 2 (14 Days)
COMPLETED
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Washout Period 2 (14 Days)
NOT COMPLETED
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Treatment Period 3 (28 Days)
STARTED
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Treatment Period 3 (28 Days)
COMPLETED
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Treatment Period 3 (28 Days)
NOT COMPLETED
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Reasons for withdrawal
| Measure |
Sequence 1: FF/VI 50/25 µg, Placebo, FF/VI 100/25 µg
Participants self-administered fluticasone furoate/vilanterol (FF/VI) 50/25 µg, placebo, and FF/VI 100/25 µg once every day (one inhalation in the morning) for 28 days via an Investigational Product Inhaler (IPI) during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
|
Sequence 2: Placebo, FF/VI 100/25 µg, FF/VI 50/25 µg
Participants self-administered placebo, FF/VI 100/25 µg, and FF/VI 50/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
|
Sequence 3: FF/VI 200/25 µg, FF/VI 50/25 µg, Placebo
Participants self-administered FF/VI 200/25 µg, FF/VI 50/25 µg, and placebo once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
|
Sequence 4: FF/VI 200/25 µg, Placebo, and FF/VI 100/25 µg
Participants self-administered FF/VI 200/25 µg, placebo, and FF/VI 100/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
|
Sequence 5: FF/VI 50/25 µg, FF/VI 100/25 µg, Placebo
Participants self-administered FF/VI 50/25 µg, FF/VI 100/25 µg, and placebo once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
|
Sequence 6: FF/VI 50/25 µg, FF/VI 200/25 µg, Placebo
Participants self-administered FF/VI 50/25 µg, FF/VI 200/25 µg, and placebo once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
|
Sequence 7: FF/VI 200/25 µg, Placebo, FF/VI 50/25 µg
Participants self-administered FF/VI 200/25 µg, placebo, and FF/VI 50/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
|
Sequence 8: Placebo, FF/VI 50/25 µg, FF/VI 100/25 µg
Participants self-administered placebo, FF/VI 50/25 µg, and FF/VI 100/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
|
Sequence 9: FF/VI 100/25 µg, FF/VI 50/25 µg, Placebo
Participants self-administered FF/VI 100/25 µg, FF/VI 50/25 µg, and placebo once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
|
Sequence 10: FF/VI 100/25 µg, Placebo, FF/VI 50/25 µg
Participants self-administered FF/VI 100/25 µg, placebo, and FF/VI 50/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
|
Sequence 11: Placebo, FF/VI 200/25 µg, FF/VI 100/25 µg
Participants self-administered placebo, FF/VI 200/25 µg, and FF/VI 100/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
|
Sequence 12: Placebo, FF/VI 200/25 µg, FF/VI 50/25 µg
Participants self-administered placebo, FF/VI 200/25 µg, and FF/VI 50/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
|
Sequence 13: Placebo, FF/VI 100/25 µg, FF/VI 200/25 µg
Participants self-administered placebo, FF/VI 100/25 µg, and FF/VI 200/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
|
Sequence 14: FF/VI 200/25 µg, FF/VI 100/25 µg, Placebo
Participants self-administered FF/VI 200/25 µg, FF/VI 100/25 µg, and placebo once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
|
Sequence 15: FF/VI 100/25 µg, FF/VI 200/25 µg, Placebo
Participants self-administered FF/VI 100/25 µg, FF/VI 200/25 µg, and placebo once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
|
Sequence 16: Placebo, FF/VI 50/25 µg, FF/VI 200/25 µg
Participants self-administered placebo, FF/VI 50/25 µg, and FF/VI 200/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
|
Sequence 17: FF/VI 50/25 µg, Placebo, FF/VI 200/25 µg
Participants self-administered FF/VI 50/25 µg, placebo, and FF/VI 200/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
|
Sequence 18: FF/VI 100/25 µg, Placebo, FF/VI 200/25 µg
Participants self-administered FF/VI 100/25 µg, placebo, and FF/VI 200/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Treatment Period 1 (28 Days)
Withdrawal by Subject
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0
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0
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1
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Treatment Period 1 (28 Days)
Protocol Violation
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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1
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Treatment Period 1 (28 Days)
Lost to Follow-up
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0
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0
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0
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0
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0
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0
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0
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0
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Treatment Period 2 (28 Days)
Lost to Follow-up
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0
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1
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0
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0
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0
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Treatment Period 2 (28 Days)
Withdrawal by Subject
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0
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0
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1
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Treatment Period 2 (28 Days)
Physician Decision
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0
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0
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0
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0
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0
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0
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0
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Washout Period 2 (14 Days)
Physician Decision
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1
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0
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Washout Period 2 (14 Days)
Withdrawal by Subject
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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1
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0
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0
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Washout Period 2 (14 Days)
Adverse Event
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0
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0
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0
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0
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0
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0
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0
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0
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0
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1
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0
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0
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Washout Period 2 (14 Days)
Lack of Efficacy
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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1
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0
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0
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0
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0
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0
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Treatment Period 3 (28 Days)
Withdrawal by Subject
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0
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0
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1
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0
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0
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0
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0
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0
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0
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0
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1
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0
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0
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0
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0
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Baseline Characteristics
A Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetic (PK), and Pharmacodynamic (PD) Profiles of 3 Doses of Fluticasone Furoate (FF)/GW642444 Inhalation Powder at the End of a 28-day Treatment Period in Subjects With Chronic Obstructive Pulmonary Disease (COPD) Compared to Placebo
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=54 Participants
All participants who self-administered placebo, FF/VI 50/25 µg, FF/VI 100/25 µg, or FF/VI 200/25 µg once every day (one inhalation in the morning) for 28 days via an IPI in any of the three 28-day treatment periods.
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|---|---|
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Age, Continuous
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57.9 Years
STANDARD_DEVIATION 9.24 • n=5 Participants
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Sex: Female, Male
Female
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29 Participants
n=5 Participants
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Sex: Female, Male
Male
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25 Participants
n=5 Participants
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Race/Ethnicity, Customized
African American/African Heritage
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6 participants
n=5 Participants
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Race/Ethnicity, Customized
White
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48 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-dose and the end of each 28-day treatment period (up to 19 weeks)Population: Intent-to-Treat (ITT) Population: all participants who were randomized to and received at least one dose of trial medication in any treatment period. Only those participants available at the indicated time points were assessed.
FEV1 is defined as the amount of air that can be forcibly exhaled from the lungs in the first second of a forced exhalation. The weighted mean was calculated from pre-dose FEV1 (calculated as the mean of the -30 and -5 minute measurements) and post-dose FEV1 after 5, 15, 30, and 60 minutes and after 2, 4, 6, 8, 12, 16, 20, 22, 23, and 24 hours. Data are provided as the Least Squares Mean of the weighted mean for all three treatment periods. Analysis was performed using a mixed effects model with covariates of period treatment group, period Baseline, mean Baseline (defined as the mean of all available period Baseline FEV1 values), and period as fixed effects and participant as a random effect.
Outcome measures
| Measure |
Placebo
n=48 Participants
Participants self-administered placebo once every day (one inhalation in the morning) for 28 days via an Investigational Product Inhaler (IPI) during one of the three 28-day treatment periods.
|
FF/VI 50/25 µg
n=32 Participants
Participants self-administered Fluticasone Furoate (FF) 50 micrograms (µg) and Vilanterol (VI) 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
|
FF/VI 100/25 µg
n=30 Participants
Participants self-administered FF 100 µg and VI 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
|
FF/VI 200/25 µg
n=30 Participants
Participants self-administered FF 200 µg and VI 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
|
|---|---|---|---|---|
|
Time-adjusted Area Under the Curve (AUC) (i.e., Weighted Mean) for 24-hour Serial Forced Expiratory Volume in One Second (FEV1) at the End of Each 28-day Treatment Period
|
1.297 Liters
Standard Error 0.0240
|
1.530 Liters
Standard Error 0.0276
|
1.517 Liters
Standard Error 0.0282
|
1.533 Liters
Standard Error 0.0282
|
SECONDARY outcome
Timeframe: From Baseline to the end of each 28-day treatment period (up to 19 weeks)Population: ITT Population. Only those participants available at the indicated time points were assessed.
Trough FEV1 is defined as the mean of the 23- and 24-hour post-dose assessments. For each treatment period, period Baseline is defined as the mean of the -30 and -5 minute measurements taken on Period Day 1. Mean Baseline FEV1 for a given participant is defined as the mean of all available period Baseline FEV1 values. Data are presented as the mean of change from Baseline for all three treatment periods. Change from Baseline was calculated as the value at Period Day 29 minus the value at Baseline. Analysis was performed using a mixed effects model with covariates of period treatment group, period Baseline, mean Baseline, and period as fixed effects and participant as a random effect.
Outcome measures
| Measure |
Placebo
n=48 Participants
Participants self-administered placebo once every day (one inhalation in the morning) for 28 days via an Investigational Product Inhaler (IPI) during one of the three 28-day treatment periods.
|
FF/VI 50/25 µg
n=32 Participants
Participants self-administered Fluticasone Furoate (FF) 50 micrograms (µg) and Vilanterol (VI) 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
|
FF/VI 100/25 µg
n=30 Participants
Participants self-administered FF 100 µg and VI 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
|
FF/VI 200/25 µg
n=30 Participants
Participants self-administered FF 200 µg and VI 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
|
|---|---|---|---|---|
|
Change From Period Baseline in Clinic Visit Trough FEV1 at the End of Each 28-day Treatment Period
|
-0.024 Liters
Standard Error 0.0286
|
0.186 Liters
Standard Error 0.0343
|
0.153 Liters
Standard Error 0.0354
|
0.165 Liters
Standard Error 0.0353
|
SECONDARY outcome
Timeframe: Baseline; pre-dose; 5 minutes, 15 minutes, 30 minutes, 60 minutes, and 2, 4, 6, 8, 12, 16, 20, 22, 23, 24, and 25 hours post-dose on Day 28 and Day 29 of each 28-day treatment period (up to 19 weeks)Population: ITT Population. Only those participants available at the indicated time points were assessed.
Change from period Baseline in 0-25 hour serial FEV1 (0 to 25 hours) over Period Days 28-29 was measured. Mean Baseline FEV1 for a given participant is defined as the mean of all available period Baseline FEV1 values. Data are presented as the mean of change from Baseline for all three treatment periods. Analysis was performed using a mixed effects repeated measures model with covariates of period treatment group, period Baseline, mean Baseline, period and time after dosing (nominal), in addition to time after dosing by period Baseline, time after dosing by mean Baseline, and time after dosing by period treatment interaction terms as fixed effects and participant as a random effect.
Outcome measures
| Measure |
Placebo
n=49 Participants
Participants self-administered placebo once every day (one inhalation in the morning) for 28 days via an Investigational Product Inhaler (IPI) during one of the three 28-day treatment periods.
|
FF/VI 50/25 µg
n=32 Participants
Participants self-administered Fluticasone Furoate (FF) 50 micrograms (µg) and Vilanterol (VI) 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
|
FF/VI 100/25 µg
n=31 Participants
Participants self-administered FF 100 µg and VI 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
|
FF/VI 200/25 µg
n=31 Participants
Participants self-administered FF 200 µg and VI 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
|
|---|---|---|---|---|
|
Change From Period Baseline in 25-hour Serial FEV1 at the End of Each 28 Day-treatment Period
60 minutes, n=49, 32, 30, 31
|
-0.002 Liters
Standard Error 0.0291
|
0.279 Liters
Standard Error 0.0342
|
0.215 Liters
Standard Error 0.0348
|
0.259 Liters
Standard Error 0.0345
|
|
Change From Period Baseline in 25-hour Serial FEV1 at the End of Each 28 Day-treatment Period
4 hours, n=49, 32, 30, 31
|
-0.037 Liters
Standard Error 0.0278
|
0.240 Liters
Standard Error 0.0326
|
0.229 Liters
Standard Error 0.0332
|
0.264 Liters
Standard Error 0.0329
|
|
Change From Period Baseline in 25-hour Serial FEV1 at the End of Each 28 Day-treatment Period
12 hours, n=48, 32, 30, 31
|
-0.058 Liters
Standard Error 0.0293
|
0.200 Liters
Standard Error 0.0343
|
0.145 Liters
Standard Error 0.0351
|
0.176 Liters
Standard Error 0.0347
|
|
Change From Period Baseline in 25-hour Serial FEV1 at the End of Each 28 Day-treatment Period
24 hours, n=48, 32, 30, 30
|
-0.015 Liters
Standard Error 0.0305
|
0.168 Liters
Standard Error 0.0358
|
0.165 Liters
Standard Error 0.0367
|
0.165 Liters
Standard Error 0.0364
|
|
Change From Period Baseline in 25-hour Serial FEV1 at the End of Each 28 Day-treatment Period
Mean pre-dose, n=49, 32, 31, 31
|
-0.017 Liters
Standard Error 0.0277
|
0.193 Liters
Standard Error 0.0325
|
0.150 Liters
Standard Error 0.0329
|
0.166 Liters
Standard Error 0.0328
|
|
Change From Period Baseline in 25-hour Serial FEV1 at the End of Each 28 Day-treatment Period
5 minutes, n=48, 32, 31, 31
|
-0.002 Liters
Standard Error 0.0289
|
0.208 Liters
Standard Error 0.0340
|
0.186 Liters
Standard Error 0.0344
|
0.217 Liters
Standard Error 0.0343
|
|
Change From Period Baseline in 25-hour Serial FEV1 at the End of Each 28 Day-treatment Period
15 minutes, n=46, 32, 31, 31
|
0.009 Liters
Standard Error 0.0298
|
0.230 Liters
Standard Error 0.0349
|
0.201 Liters
Standard Error 0.0354
|
0.215 Liters
Standard Error 0.0353
|
|
Change From Period Baseline in 25-hour Serial FEV1 at the End of Each 28 Day-treatment Period
30 minutes, n=49, 32, 30, 31
|
0.006 Liters
Standard Error 0.0304
|
0.255 Liters
Standard Error 0.0359
|
0.200 Liters
Standard Error 0.0365
|
0.240 Liters
Standard Error 0.0363
|
|
Change From Period Baseline in 25-hour Serial FEV1 at the End of Each 28 Day-treatment Period
2 hours, n=49, 32, 30, 31
|
-0.003 Liters
Standard Error 0.0283
|
0.282 Liters
Standard Error 0.0332
|
0.280 Liters
Standard Error 0.0338
|
0.279 Liters
Standard Error 0.0335
|
|
Change From Period Baseline in 25-hour Serial FEV1 at the End of Each 28 Day-treatment Period
6 hours, n=49, 32, 30, 31
|
-0.029 Liters
Standard Error 0.0264
|
0.202 Liters
Standard Error 0.0306
|
0.221 Liters
Standard Error 0.0312
|
0.246 Liters
Standard Error 0.0309
|
|
Change From Period Baseline in 25-hour Serial FEV1 at the End of Each 28 Day-treatment Period
8 hours, n=49, 32, 30, 31
|
-0.063 Liters
Standard Error 0.0276
|
0.187 Liters
Standard Error 0.0322
|
0.182 Liters
Standard Error 0.0329
|
0.187 Liters
Standard Error 0.0325
|
|
Change From Period Baseline in 25-hour Serial FEV1 at the End of Each 28 Day-treatment Period
16 hours, n=48, 32, 29, 31
|
-0.105 Liters
Standard Error 0.0289
|
0.129 Liters
Standard Error 0.0338
|
0.093 Liters
Standard Error 0.0347
|
0.067 Liters
Standard Error 0.0341
|
|
Change From Period Baseline in 25-hour Serial FEV1 at the End of Each 28 Day-treatment Period
20 hours, n=48, 32, 30, 30
|
-0.127 Liters
Standard Error 0.0309
|
0.073 Liters
Standard Error 0.0364
|
0.071 Liters
Standard Error 0.0373
|
0.046 Liters
Standard Error 0.0370
|
|
Change From Period Baseline in 25-hour Serial FEV1 at the End of Each 28 Day-treatment Period
22 hours, n=48, 32, 30, 30
|
-0.042 Liters
Standard Error 0.0294
|
0.116 Liters
Standard Error 0.0345
|
0.124 Liters
Standard Error 0.0353
|
0.155 Liters
Standard Error 0.0351
|
|
Change From Period Baseline in 25-hour Serial FEV1 at the End of Each 28 Day-treatment Period
23 hours, n=48, 32, 30, 30
|
-0.042 Liters
Standard Error 0.0310
|
0.168 Liters
Standard Error 0.0365
|
0.137 Liters
Standard Error 0.0374
|
0.157 Liters
Standard Error 0.0371
|
|
Change From Period Baseline in 25-hour Serial FEV1 at the End of Each 28 Day-treatment Period
25 hours, n=48, 32, 30, 29
|
0.018 Liters
Standard Error 0.0272
|
0.170 Liters
Standard Error 0.0317
|
0.166 Liters
Standard Error 0.0323
|
0.192 Liters
Standard Error 0.0322
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
FF/VI 50/25 µg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
FF/VI 100/25 µg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
FF/VI 200/25 µg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=51 participants at risk
Participants self-administered placebo once every day (one inhalation in the morning) for 28 days via an Investigational Product Inhaler (IPI) during one of the three 28-day treatment periods.
|
FF/VI 50/25 µg
n=34 participants at risk
Participants self-administered Fluticasone Furoate (FF) 50 micrograms (µg) and Vilanterol (VI) 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
|
FF/VI 100/25 µg
n=33 participants at risk
Participants self-administered FF 100 µg and VI 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
|
FF/VI 200/25 µg
n=31 participants at risk
Participants self-administered FF 200 µg and VI 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
|
|---|---|---|---|---|
|
Infections and infestations
Cellulitis
|
0.00%
0/51 • On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.
|
0.00%
0/34 • On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.
|
3.0%
1/33 • On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.
|
0.00%
0/31 • On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/51 • On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.
|
0.00%
0/34 • On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.
|
3.0%
1/33 • On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.
|
0.00%
0/31 • On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/51 • On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.
|
2.9%
1/34 • On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.
|
0.00%
0/33 • On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.
|
0.00%
0/31 • On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/51 • On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.
|
0.00%
0/34 • On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.
|
3.0%
1/33 • On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.
|
0.00%
0/31 • On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.
|
|
Infections and infestations
Urinary tract infection
|
2.0%
1/51 • On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.
|
0.00%
0/34 • On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.
|
0.00%
0/33 • On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.
|
0.00%
0/31 • On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/51 • On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.
|
2.9%
1/34 • On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.
|
0.00%
0/33 • On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.
|
0.00%
0/31 • On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/51 • On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.
|
2.9%
1/34 • On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.
|
0.00%
0/33 • On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.
|
0.00%
0/31 • On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.0%
1/51 • On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.
|
0.00%
0/34 • On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.
|
0.00%
0/33 • On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.
|
0.00%
0/31 • On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal inflammation
|
0.00%
0/51 • On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.
|
0.00%
0/34 • On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.
|
0.00%
0/33 • On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.
|
3.2%
1/31 • On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
2.0%
1/51 • On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.
|
0.00%
0/34 • On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.
|
0.00%
0/33 • On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.
|
0.00%
0/31 • On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/51 • On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.
|
0.00%
0/34 • On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.
|
3.0%
1/33 • On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.
|
0.00%
0/31 • On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/51 • On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.
|
0.00%
0/34 • On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.
|
3.0%
1/33 • On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.
|
0.00%
0/31 • On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.
|
|
Injury, poisoning and procedural complications
Caustic injury
|
0.00%
0/51 • On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.
|
0.00%
0/34 • On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.
|
0.00%
0/33 • On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.
|
3.2%
1/31 • On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/51 • On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.
|
0.00%
0/34 • On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.
|
0.00%
0/33 • On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.
|
3.2%
1/31 • On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.
|
|
Nervous system disorders
Headache
|
0.00%
0/51 • On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.
|
2.9%
1/34 • On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.
|
0.00%
0/33 • On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.
|
0.00%
0/31 • On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.
|
|
Vascular disorders
Raynaud's phenomenon
|
0.00%
0/51 • On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.
|
2.9%
1/34 • On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.
|
0.00%
0/33 • On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.
|
0.00%
0/31 • On-treatment adverse events (AEs), defined as those events occurring while participants were on double-blind treatment, up to and including the day after the last dose in each treatment period (up to 19 weeks), are reported.
|
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