Conditions: Pulmonary Disease, Chronic Obstructive
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 519
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the 24-hour spirometry effect (FEV1) of FF/VI 100/25mcg once daily compared with Fluticasone Propionate/Salmeterol 250/50mcg twice daily over a 12-week treatment period in subjects with COPD.

Detailed description:
This is a randomized, double-blind, double-dummy, multi-centre parallel group study. Subjects who meet the eligibility criteria at Screening and meet the randomization criteria at the end of a 2-week Run-In period will enter a 12-week treatment period. There will be a 7-day Follow-up period after the treatment period.

Arms:
arm 1: Inhaled Corticosteroid (ICS)/ Long acting Beta Agonist (LABA) arm 2: Inhaled Corticosteroid (ICS)/ Long acting Beta Agonist (LABA)

Interventions: intervention 1: Fluticasone Furoate 100mcg / GW642444 (vilanterol) 25mcg intervention 2: Fluticasone Propionate 250mcg/ salmeterol 50mcg
Intervention descriptions: intervention 1: inhalation powder intervention 2: inhalation powder

Protocol document: