Advair® DISKUS® Versus Serevent® DISKUS® For Chronic Obstructive Pulmonary Disease Exacerbations

Phase 4

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive

• Registration Number: NCT00115492
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This study evaluates the effect of two medicines on COPD (Chronic Obstructive Pulmonary Disease) exacerbations. This study will last up to 56 weeks, and subjects will visit the clinic 10 times. Subjects will be given breathing tests and will record their breathing symptoms daily on diary cards. All study related medicines and medical examinations will be provided at no cost. The two drugs used in this study have been approved by FDA for use in patients with COPD.

Detailed Description

A Randomized, Double-Blind, Parallel Group, 52-week Study to Compare the Effect of the Fluticasone Propionate/Salmeterol DISKUS Combination Product 250/50mcg BID with Salmeterol DISKUS 50mcg BID on the Annual Rate of Moderate/Severe Exacerbations in Subjects with Chronic Obstructive Pulmonary Disease (COPD)

Study Timeline

• Study Start: 2004-12
• Study First Submitted: 2005-06-22
• Study First Submitted QC: 2005-06-22
• Study First Posted: 2005-06-23
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-19
• Last Update Posted: 2017-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 797

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rate of moderate/severe exacerbations over a 52 week treatment period

Secondary Outcome Measures

Name	Time	Method
The time until the first moderate/severe exacerbation; the annual rate of exacerbations requiring oral corticosteroid treatment, and breathing tests conducted over one year

Trial Locations

Locations (1)

GSK Investigational Site; 🇨🇦 Trois Rivieres, Quebec, Canada