Survival Of Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Condition(s) targeted: Chronic Obstructive Pulmonary Disease

Intervention: Salmeterol 50mcg/ Fluticasone Propionate 500mcg (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline

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.

Official title: 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.

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: All cause mortality at 3 years

Secondary outcome: Rate of moderate and severe COPD exacerbations and health status assessed by the St. George's Respiratory Questionnaire.

Minimum age: 40 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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.

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Starting date: September 2000
Last updated: December 21, 2005