Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
A Phase III, 4-week, Randomized, Double-blind Study to Compare 'Closed' Triple Therapy (FF/UMEC/VI), 'Open' Triple Therapy (FF/VI + UMEC) and Dual Therapy (FF/VI) in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
The primary purpose of this study is to assess the equivalence of closed triple therapy
Fluticasone Furoate (FF)/Umeclidinium (UMEC)/Vilanterol (VI) to open triple therapy (FF/VI +
UMEC), with a comparison of both triple therapies to dual therapy (FF/VI) on lung function.
This is a phase III, 4-week, randomized, double-blind, parallel group, multicenter study
comparing FF/UMEC/VI (100 micrograms [mcg]/62.5 mcg/25 mcg) delivered via a single ELLIPTA®
inhaler ('closed' triple) + matching placebo ELLIPTA inhaler, FF/VI + UMEC delivered via two
ELLIPTA inhalers ('open' triple) and FF/VI via a single ELLIPTA inhaler + matching placebo
ELLIPTA inhaler, all once daily. The total duration of subject participation will be
approximately 7 weeks, consisting of a 2-week run-in period, 4-week treatment period and a
1-week follow-up period.
ELLIPTA is a registered trade mark of the GSK group of companies.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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