Survival Of Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Phase 3
Completed
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Registration Number
- NCT00268216
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
The purpose of this study is to see if fluticasone 500mcg/salmeterol 50mcg can improve the survival of subjects with COPD and also assess the long term safety profile of this drug.
- Detailed Description
A multicenter, randomized, double-blind, parallel group, placebo controlled study to investigate the effects of salmeterol/fluticasone 50/500mcg bd, salmeterol 50mcg bd, and fluticasone 500mcg bd, all delivered via the DISKUS/ACCUHALER inhaler, on the survival of subjects with chronic obstructive pulmonary disease over 3 years of treatment.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6228
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method All cause mortality at 3 years
- Secondary Outcome Measures
Name Time Method Rate of moderate and severe COPD exacerbations and health status assessed by the St. George's Respiratory Questionnaire.
Trial Locations
- Locations (1)
GSK Investigational Site
Location not specified
GSK Investigational Site