At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 528 enrolled
Drug / intervention
Fluticasone Furoate 100mcg/Vilanterol 25mcg +1 moredrug
Likely dose
Fluticasone Furoate 100mcg/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 of Fluticasone Furoate (FF)/Vilanterol Inhalation Powder (FF/VI Inhalation Powder) Once Daily Compared With Salmeterol/Fluticasone Propionate (FP) Inhalation Powder Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
In Brief
A Phase 3 clinical trial evaluating Fluticasone Furoate 100mcg/Vilanterol 25mcg and Fluticaosne Propionate 500mcg/Salmeterol 50mcg for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 528 participants across 66 sites in 9 countries.
Detailed Summary
The purpose of this study is to evaluate the 24-hour spirometry effect (FEV1) of Fluticasone Furoate/Vilanterol 100/25mcg once daily compared with Salmeterol/Fluticasone Propionate 50/500mcg twice daily over a 12-week treatmen period in subjects with COPD.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Disease, Chronic Obstructive
CountriesBelgium, France, Germany, Italy, Philippines, Poland, Russia, Spain, Ukraine
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2011
First PostedApr 2011
Primary CompletionOct 2011
Study CompletionOct 2011
TodayJul 2026
First PostedApr 27, 2011
Enrollment StartFeb 1, 2011
Primary CompletionOct 1, 2011
Study CompletionOct 19, 2011
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 15.2 years ago
Interventions
Fluticasone Furoate 100mcg/Vilanterol 25mcgdrug
Inhalation Powder
Fluticaosne Propionate 500mcg/Salmeterol 50mcgdrug
Inhalation Powder