CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 16,568 enrolled
Drug / intervention
fluticasone furoate/vilanterol +3 moredrug
Likely dose
fluticasone furoate/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.

Search/NCT01313676
NCT01313676Phase 3Completed
CompareCT.gov

A Clinical Outcomes Study to Compare the Effect of Fluticasone Furoate/Vilanterol Inhalation Powder 100/25mcg With Placebo on Survival in Subjects With Moderate Chronic Obstructive Pulmonary Disease (COPD) and a History of or at Increased Risk for Cardiovascular Disease

GlaxoSmithKline·interventional·Posted Mar 14, 2011·Updated Aug 6, 2018

In Brief

A Phase 3 clinical trial evaluating fluticasone furoate/vilanterol, fluticasone furoate, and 2 other interventions for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 16,568 participants across 1,611 sites in 44 countries.

Detailed Summary

The purpose of this study is to determine if fluticasone furoate/vilanterol improves survival in patients with chronic obstructive pulmonary disease with a history of or increased risk of heart disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Disease, Chronic Obstructive
CountriesArgentina, Australia, Austria, Belarus, Belgium, Bosnia and Herzegovina, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czechia, France, Georgia, Germany, Greece, Hungary, India, Indonesia, Israel, Italy, Japan, Latvia, Malaysia, Mexico, Netherlands, North Macedonia, Philippines, Poland, Romania, Russia, Serbia, Slovakia, South Africa, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom, United States, Vietnam
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 14, 2011
Enrollment StartJan 25, 2011
Primary CompletionJul 15, 2015
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 15.3 years ago

Interventions

fluticasone furoate/vilanteroldrug

100/25mcg given once daily via novel dry powder inhaler

fluticasone furoatedrug

100mcg given once daily via novel dry powder inhaler

vilanteroldrug

25mcg given once daily via novel dry powder inhaler

Placeboother

placebo comparator once daily via novel dry powder inhaler