Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Cardiovascular event Cardiovascular disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 623
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the 24-hour spirometry effect (FEV1) of Fluticasone Furoate/Vilanterol Inhalation Powder 100/25mcg once daily compared with tiotropium bromide inhalation powder 18mcg once daily over a 12-week treatment period in subjects with COPD who have or are at risk for co-morbid cardiovascular disease

Detailed description:
This is a randomized, double-blind, double-dummy, multi-center, parallel-group study. Subjects who meet the eligibility criteria at Screening and 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 beta2-agonist (LABA) arm 2: anticholinergic

Interventions: intervention 1: fluticasone furoate/vilanterol 100/25mcg intervention 2: tiotropium bromide 18mcg
Intervention descriptions: intervention 1: inhalation powder intervention 2: inhalation powder

Protocol document: