Status:
COMPLETED
Advair® DISKUS® Versus Serevent® DISKUS® For Chronic Obstructive Pulmonary Disease Exacerbations
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 Combination Product 250/50mcg BID with Salmeterol DISKUS 50mcg BID on th...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
797 Patients enrolled
Trial Details
Trial ID
NCT00115492
Start Date
December 1 2004
End Date
June 1 2007
Last Update
January 20 2017
Active Locations (110)
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1
GSK Investigational Site
Jasper, Alabama, United States, 35501
2
GSK Investigational Site
Mobile, Alabama, United States, 36608
3
GSK Investigational Site
Glendale, Arizona, United States, 85306
4
GSK Investigational Site
Phoenix, Arizona, United States, 85013