drugset / Trial / NCT01772147

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.

NCT01772147

Phase 3 Completed 608 enrolled GlaxoSmithKline
RandomizedParallel-groupDouble-blindTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Umeclidinium Other / unclassified 62.5 ug Inhaled
Subject Umeclidinium Other / unclassified 125 ug Inhaled
Comparator Fluticasone propionate Other / unclassified 250 ug Inhaled
Comparator Salmeterol Other / unclassified 50 ug Inhaled