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Completed

NCT Number: NCT00115492

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

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.

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

GSK Investigational Site, Vancouver, British Columbia, Canada

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About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fluticasone Propionate/Salmeterol Combination Product

Drug

Salmeterol

Drug

Other names: Fluticasone Propionate/Salmeterol Combination Product

Primary outcomes

  1. Rate of moderate/severe exacerbations over a 52 week treatment period

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Randomized, Double-Blind, Parallel Group, 52-Week Study to Compare the Effect of 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

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Jun 23, 2005
Registry last updated
Jan 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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