CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 349 enrolled
Drug / intervention
GSK 573719 +GW642444 125/25 +5 moredrug
Likely dose
GSK 573719 +GW642444 125/25 125mcgfrom 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/NCT01328444
NCT01328444Phase 3Completed
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An Exercise Endurance Study to Evaluate the Effects of Treatment of Chronic Obstructive Pulmonary Disease (COPD) Patients With a Dual Bronchodilator: GSK573719/GW642444. Study A

GlaxoSmithKline·interventional·Posted Apr 4, 2011·Updated Oct 11, 2017

In Brief

A Phase 3 clinical trial evaluating GSK 573719 +GW642444 125/25, GSK573719 + GW642444 62.5/25, and 4 other interventions for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 349 participants across 31 sites in 6 countries.

Detailed Summary

This is a phase III multicenter, randomized, double-blind, placebo-controlled, combination and component, two-period, incomplete block design cross-over study using GSK573719/GW642444. The primary objective is to evaluate lung function and exercise endurance time after 12 weeks of once-daily administration of GSK573719/GW642444 Inhalation Powder (125/25mcg and 62.5/25mcg), GSK573719 Inhalation Powder (125mcg and 62.5mcg), GW642444 Inhalation Powder 25 mcg and placebo delivered by a Novel dry powder inhaler (Novel DPI)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Disease, Chronic Obstructive
CountriesBulgaria, Estonia, Germany, Russia, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 4, 2011
Enrollment StartMar 1, 2011
Primary CompletionJun 1, 2012
Study CompletionJun 14, 2012
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 15.2 years ago

Interventions

GSK 573719 +GW642444 125/25drug

125mcg/ 25mcg

GSK573719 + GW642444 62.5/25drug

62.5mcg/25mcg

GSK 573719 125drug

125mcg

GSK 573719 62.5drug

62.5mcg

GW642444 25drug

25mcg

Plbdrug

Comparator