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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2000-09
• Primary Completion: 2005-11
• Study Completion: 2005-11
• Study First Submitted: 2005-12-20
• Study First Submitted QC: 2005-12-21
• Study First Posted: 2005-12-22
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-19
• Last Update Posted: 2017-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6228

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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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