Status:
COMPLETED
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.
Lead Sponsor:
GlaxoSmithKline
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40+ years
Phase:
PHASE4
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. Subjec...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
740 Patients enrolled
Trial Details
Trial ID
NCT00144911
Start Date
October 1 2004
End Date
December 1 2006
Last Update
October 28 2016
Active Locations (97)
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1
GSK Investigational Site
Birmingham, Alabama, United States, 35209
2
GSK Investigational Site
Birmingham, Alabama, United States, 35294-0012
3
GSK Investigational Site
Jasper, Alabama, United States, 35501
4
GSK Investigational Site
Glendale, Arizona, United States, 85306