Efficacy and Safety of the Addition of Fluticasone Propionate/Salmeterol (250/50mcg) Twice-daily to 2 Doses of Umeclidinium Bromide Inhalation Powder (62.5 or 125mcg) Once-daily Over 12 Weeks.

Summary

The purpose of this 12 week study is to evaluate the effects of the addition of umeclidinium bromide (62.5mcg) once-daily to fluticasone propionate (250/50mcg) twice-daily and umeclidinium bromide (125mcg) once-daily to fluticasone propionate (250/50mcg) twice-daily with placebo when added to fluticasone propionate (250/50mcg) twice-daily on lung function, COPD-related health status assessments and safety in COPD subjects.

Timeline

Start

2013-01

Primary completion

2013-08

Completion

2013-08

Outcome

Met primary endpoint

registry Placebo QD + FSC 250/50 µg BID vs UMEC 62.5 µg QD + FSC 250/50 µg BID; p <0.001; Mean Difference (Net) 0.127 (95% CI 0.089 to 0.164) NCT01772147 ↗

Drugs

Indications