Study to Evaluate the Effect of Fluticasone Furoate/Vilanterol on Survival in Subjects With Chronic Obstructive Pulmonary Disease
NCT01313676 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 16568
Last updated 2018-08-06
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.
Conditions
- Pulmonary Disease, Chronic Obstructive
Interventions
- DRUG
-
fluticasone furoate/vilanterol
100/25mcg given once daily via novel dry powder inhaler
- DRUG
-
fluticasone furoate
100mcg given once daily via novel dry powder inhaler
- DRUG
-
vilanterol
25mcg given once daily via novel dry powder inhaler
- OTHER
-
Placebo
placebo comparator once daily via novel dry powder inhaler
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
GSK Clinical Trials · GlaxoSmithKline
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-01-25
- Primary Completion
- 2015-07-15
- Completion
- 2015-07-15
Countries
- United States
- Argentina
- 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
- Vietnam
Study Locations
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