drugset / Trial / NCT01316887

A 52-Week, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Safety and Tolerability of GSK573719/GW642444 and GSK573719 in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

NCT01316887

Phase 3 Completed 563 enrolled GlaxoSmithKline
RandomizedParallel-groupDouble-blindOther

Summary

The purpose of this 52-week study is to evaluate the long-term safety (in terms of adverse events, COPD exacerbations, laboratory, ECG, and Holter findings, vital signs, use of rescue medication and lung function) of GSK573719/GW642444 Inhalation Powder 125/25mcg in subjects with COPD. The long-term safety of GSK573719 Inhalation Powder 125mcg will also be evaluated. A placebo arm is included to evaluate these products compared to an inactive control.

Timeline

Start
2011-01-01
Primary completion
2012-07-01
Completion
2012-07-21

Drugs

EvaluationDrugModalityDoseRoute
Subject Umeclidinium Other / unclassified 125 ug Inhaled
Subject Vilanterol Other / unclassified 25 ug Inhaled