Status:
COMPLETED
Survival Of Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
GlaxoSmithKline
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40-80 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patients with COPD and FEV1 \<60% of predicted normal and baseline (pre-bronchodilator) FEV1/FVC ratio \<70%.
- Current or ex-smokers with a smoking history of at least 10 pack-years.
- Exclusion criteria:
- Diagnosis of other respiratory disorders (including asthma).
- Requirement for long term oxygen therapy.
Exclusion
Key Trial Info
Start Date :
September 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2005
Estimated Enrollment :
6228 Patients enrolled
Trial Details
Trial ID
NCT00268216
Start Date
September 1 2000
End Date
November 1 2005
Last Update
January 20 2017
Active Locations (459)
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1
GSK Investigational Site
Birmingham, Alabama, United States, 35235
2
GSK Investigational Site
Birmingham, Alabama, United States, 35294-7340
3
GSK Investigational Site
Birmingham, Alabama, United States, 35294
4
GSK Investigational Site
Jasper, Alabama, United States, 35501