NCT02731846

A Study Comparing the Closed Triple Therapy, Open Triple Therapy and a Dual Therapy for Effect on Lung Function in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

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)

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Pulmonary Disease, Chronic Obstructive

Interventions

Type	Name	Description
DRUG	Fluticasone furoate 100 mcg + Umeclidinium 62.5 mcg+Vilanterol 25 mcg	Dry white powder delivered via ELLIPTA inhaler(2 strips with 30 blisters each, first containing fluticasone furoate 100 mcg per blister and second containing Umeclidinium 62.5 mcg and Vilanterol 25 mcg per blister), administered as one inhalation of FF/UMEC/VI (100/62.5/25 mcg) once-daily in the morning
DRUG	Fluticasone furoate 100 mcg + Vilanterol 25 mcg	Dry white powder delivered via ELLIPTA inhaler (2 strips with 30 blisters each, first containing fluticasone furoate 100 mcg per blister and second containing Vilanterol 25 mcg per blister), administered as one inhalation of FF/VI (100/25 mcg) once-daily in the morning
DRUG	Umeclidinium 62.5 mcg	Dry white powder delivered via ELLIPTA inhaler (1 strip with 30 blisters containing Umeclidinium 62.5 mcg, administered as one inhalation once-daily in the morning
DEVICE	Placebo ELLIPTA inhaler	Placebo will be administered via ELLIPTA inhaler. Dry white powder administered as one inhalation each morning (1 strip with 30 blisters containing placebo)
DRUG	Albuterol/Salbutamol	Albuterol/salbutamol will be administered via metered-dose inhaler (MDI) with a spacer as needed throughout the study as a rescue medication

Timeline

• Start date: 2016-06-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2016-04-08
• Last updated: 2016-07-22

Locations

11 sites across 2 countries: Canada, Germany