At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 623 enrolled
Drug / intervention
fluticasone furoate/vilanterol 100/25mcg +1 moredrug
Likely dose
fluticasone furoate/vilanterol 100/25mcgfrom 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 100/25mcg Once-Daily Via a Novel Dry Powder Inhaler Compared With Tiotropium Bromide Inhalation Powder 18mcg Delivered Once-Daily Via the HandiHaler in Subjects With Chronic Obstructive Pulmonary Disease (COPD) Who Have or Are at Risk for Co-morbid Cardiovascular Disease
In Brief
A Phase 3 clinical trial evaluating fluticasone furoate/vilanterol 100/25mcg and tiotropium bromide 18mcg for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 623 participants across 54 sites in 6 countries.
Detailed Summary
The purpose of this study is to evaluate the 24-hour spirometry effect (FEV1) of Fluticasone Furoate/Vilanterol Inhalation Powder 100/25mcg once daily compared with tiotropium bromide inhalation powder 18mcg once daily over a 12-week treatment period in subjects with COPD who have or are at risk for co-morbid cardiovascular disease
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Disease, Chronic Obstructive
CountriesCanada, Czechia, Germany, Poland, Romania, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartApr 2012
First PostedJun 2012
Primary CompletionDec 2012
Study CompletionDec 2012
TodayJul 2026
First PostedJun 25, 2012
Enrollment StartApr 1, 2012
Primary CompletionDec 1, 2012
Study CompletionDec 21, 2012
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 14.0 years ago
Interventions
fluticasone furoate/vilanterol 100/25mcgdrug
inhalation powder
tiotropium bromide 18mcgdrug
inhalation powder