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)

NCT02731846 Phase 3 WITHDRAWN

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.

Details

Lead sponsor	GlaxoSmithKline
Phase	Phase 3
Status	WITHDRAWN
Start date	2016-06
Completion	2016-11

Conditions

• Pulmonary Disease, Chronic Obstructive

Interventions

• Fluticasone furoate 100 mcg + Umeclidinium 62.5 mcg+Vilanterol 25 mcg
• Fluticasone furoate 100 mcg + Vilanterol 25 mcg
• Umeclidinium 62.5 mcg
• Placebo ELLIPTA inhaler
• Albuterol/Salbutamol

Primary outcomes

• Change from baseline in trough forced expiratory volume in one second (FEV1) on Day 29 — Up to Day 29
  Forced Expiratory Volume (FEV1) is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second

Countries

Canada, Germany