ADVAIR® DISKUS® Inhaler (Fluticasone Propionate/Salmeterol) Versus SEREVENT® DISKUS® Inhaler (Salmeterol) For The Treatment Of Chronic Obstructive Pulmonary Disease Exacerbations. ADVAIR® DISKUS® Inhaler and SEREVENT® DISKUS® Inhaler Are Trademarks of the GSK Group of Companies.

Phase 4

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: Salmeterol; Drug: Fluticasone Propionate/Salmeterol Combination Product

• Registration Number: NCT00144911
• 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 the 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® inhaler Combination Product 250/50mcg twice daily (BID) with Salmeterol DISKUS® inhaler 50mcg BID on the Annual Rate of Moderate/Severe Exacerbations in Subjects with Chronic Obstructive Pulmonary Disease (COPD)

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2005-09-01
• Study First Submitted QC: 2005-09-01
• Study First Posted: 2005-09-05
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-26
• Last Update Posted: 2016-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 740

Inclusion Criteria

• Diagnosis of COPD (chronic obstructive pulmonary disease).
• Current or previous cigarette smokers with a smoking history of at least 10 pack-years.
• History of a least 1 COPD exacerbation in the 12 months prior to screening.
• Forced expiratory volume in one second (FEV1) of less than or equal to 50% of predicted normal.

Exclusion Criteria

• Current diagnosis of asthma.
• Additional respiratory disorders other than COPD (eg, sarcoidosis, alpha-1 antitrypsin deficiency, cystic fibrosis, or active tuberculosis).
• Concurrent use of long-acting beta-agonists, long-acting anticholinergics, inhaled and oral corticosteroids, theophylline, investigational medications, ritonavir, and anti-leukotrienes.
• Lung resection surgery within 1 year of screening.
• Abnormal and clinically significant ECG findings at screening.
• Other inclusion and exclusion criteria will be evaluated at the first study visit.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Salmeterol	-
Arm 1	Fluticasone Propionate/Salmeterol Combination Product	-

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; 🇨🇦 Sorel, Quebec, Canada