Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
mortality, TORCH, SERETIDE, ADVAIR, COPD
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.
Interventions
Sponsors
Study design
Eligibility
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All cause mortality at 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of moderate and severe COPD exacerbations and health status assessed by the St. George's Respiratory Questionnaire. | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Croatia, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, Italy, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Pakistan, Philippines, Poland, Puerto Rico, Romania, Russia, Singapore, Slovakia, South Africa, Spain, Sweden, Taiwan, Thailand, Ukraine, United Kingdom, United States