NCT Number: NCT00144911
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.
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.
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Notify MeKey information
Conditions
Age range
40 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
GSK Investigational Site, Calgary, Alberta, Canada
About this study
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)
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Fluticasone Propionate/Salmeterol Combination Product
DrugOther names: Salmeterol
Primary outcomes
-
Rate of moderate/severe exacerbations over a 52 week treatment period.
Secondary outcomes
-
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® Inhaler Combination Product 250/50mcg Twice Daily With Salmeterol DISKUS® Inhaler 50mcg Twice Daily on the Annual Rate of Moderate/Severe Exacerbations in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Important dates
- Study start
- 2004
- Primary completion
- 2006
- Study completion
- 2006
- First posted
- Sep 5, 2005
- Registry last updated
- Oct 28, 2016
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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