CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 563 enrolled
Drug / intervention
125/25 mcg once-daily GSK573719/GW642444 +2 moredrug
Likely dose
125/25 mcg once-daily GSK573719/GW642444from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01316887
NCT01316887Phase 3Completed

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

GlaxoSmithKline·interventional·Posted Mar 16, 2011·Updated May 2, 2018

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChile, Romania, Russia, Slovakia, South Africa, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 16, 2011
Enrollment StartJan 1, 2011
Primary CompletionJul 1, 2012
Study CompletionJul 21, 2012
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 15.3 years ago

Interventions

125/25 mcg once-daily GSK573719/GW642444drug

GSK573719/GW642444

125mcg once-daily GSK573719drug

GSK573719

Placebo once-dailydrug

inactive