Study to Evaluate the 24-Hour Pulmonary Function Profile of Fluticasone Furoate/Vilanterol (FF/VI) Inhalation Powder 100/25mcg Once Daily Compared With Tiotropium Bromide Inhalation Powder 18mcg Once Daily in Subjects With COPD Who Have or Are At Risk for Co-morbid Cardiovascular Disease

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

Timeline

Start

2012-04-01

Primary completion

2012-12-01

Completion

2012-12-21

Outcome

Missed primary endpoint

registry analysis (superiority or other test); FF/VI 100/25 µg OD vs TIO 18 µg OD; p = 0.201; Median Difference (Net) 0.022 (95% CI -0.012 to 0.055); ANCOVA NCT01627327 ↗

Drugs

Indications