At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 519 enrolled
Drug / intervention
Fluticasone Furoate 100mcg / GW642444 (vilanterol) 25mcg +1 moredrug
Likely dose
Fluticasone Furoate 100mcg / GW642444 (vilanterol) 25mcgfrom 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.
A 12-week Study to Evaluate the 24-hour Pulmonary Function Profile of Fluticasone Furoate/Vilanterol (FF/VI) Inhalation Powder 100/25 mcg Once Daily Compared With Fluticasone Propionate/Salmeterol Inhalation Powder 250/50 mcg Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
In Brief
A Phase 3 clinical trial evaluating Fluticasone Furoate 100mcg / GW642444 (vilanterol) 25mcg and Fluticasone Propionate 250mcg/ salmeterol 50mcg for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 519 participants across 50 sites in 6 countries.
Detailed Summary
The purpose of this study is to evaluate the 24-hour spirometry effect (FEV1) of FF/VI 100/25mcg once daily compared with Fluticasone Propionate/Salmeterol 250/50mcg twice daily over a 12-week treatment period in subjects with COPD.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Disease, Chronic Obstructive
CountriesCzechia, Germany, Poland, Romania, Russia, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2011
First PostedMar 2011
Primary CompletionDec 2011
TodayJul 2026
First PostedMar 25, 2011
Enrollment StartMar 18, 2011
Primary CompletionDec 14, 2011
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 15.3 years ago
Interventions
Fluticasone Furoate 100mcg / GW642444 (vilanterol) 25mcgdrug
inhalation powder
Fluticasone Propionate 250mcg/ salmeterol 50mcgdrug
inhalation powder