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

Condition(s) targeted: Chronic Obstructive Pulmonary Disease

Intervention: Fluticasone Propionate/Salmeterol Combination Product (Drug); Salmeterol (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: GlaxoSmithKline

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

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.

Official title: 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 design: Treatment, Randomized, Double-Blind, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Rate of moderate/severe exacerbations over a 52 week treatment period

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

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion criteria:

- Diagnosis of COPD.

- Current or previous cigarette smokers with a smoking history of at least 10

pack-years.

- History of at 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:

- 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.

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Starting date: December 2004
Last updated: November 6, 2007