At a glance
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A 52 Week Study to Evaluate the Safety and Tolerability of GSK573719/GW642444 125mcg Once-daily Alone and in Combination With GW642444 25mcg Once-daily Via Novel Dry Powder Inhaler (nDPI) in Subjects With Chronic Obstructive Pulmonary Disease
In Brief
A Phase 3 clinical trial evaluating 125/25 mcg once-daily GSK573719/GW642444, 125mcg once-daily GSK573719, and 1 other intervention for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 563 participants across 54 sites in 6 countries.
Detailed 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.
Study Details
Timeline
Interventions
GSK573719/GW642444
GSK573719
inactive