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Clinical Trial Name - Advair® DISKUS® Versus Serevent® DISKUS® For Chronic Obstructive Pulmonary Disease Exacerbatio

 
Original Study ID : SCO100250
NCT ID : NCT00115492
Brief Title : Advair® DISKUS® Versus Serevent® DISKUS® For Chronic Obstructive Pulmonary Disease Exacerbations
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)
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. 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.

Source : GlaxoSmithKline
Overall Status : Completed
Start Date : December 2004
Official Title : Phase 4
Phase : Interventional
Study Design : Treatment, Randomized, Double-Blind, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Enrollment : 740
Verification Date : November 2007
First Received Date : June 22, 2005
Trial Eligibility
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.
Gender : Both
Minimum Age : 40 Years
Maximum Age : N/A
Healthy Volunteers : No
Facilities
Facility Name : GSK Clinical Trials Call Center
City : Mobile
State : Alabama
Zip Code : 36608
Country : United States
Facility Name : GSK Clinical Trials Call Center
City : Birmingham
State : Alabama
Zip Code : 35294
Country : United States
Facility Name : GSK Clinical Trials Call Center
City : Jasper
State : Alabama
Zip Code : 35501
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Facility Name : GSK Clinical Trials Call Center
City : Phoenix
State : Arizona
Zip Code : 85013
Country : United States
Facility Name : GSK Clinical Trials Call Center
City : Glendale
State : Arizona
Zip Code : 85306
Country : United States
Facility Name : GSK Clinical Trials Call Center
City : Vista
State : California
Zip Code : 92084
Country : United States
Facility Name : GSK Clinical Trials Call Center
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Zip Code : 92835
Country : United States
Facility Name : GSK Clinical Trials Call Center
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Zip Code : 92123
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Facility Name : GSK Clinical Trials Call Center
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State : California
Zip Code : 94705
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Facility Name : GSK Clinical Trials Call Center
City : Riverside
State : California
Zip Code : 92506
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Facility Name : GSK Clinical Trials Call Center
City : Sacramento
State : California
Zip Code : 95825
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Facility Name : GSK Clinical Trials Call Center
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State : Colorado
Zip Code : 80528
Country : United States
Facility Name : GSK Clinical Trials Call Center
City : Stamford
State : Connecticut
Zip Code : 06902
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State : Florida
Zip Code : 33316
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City : Vancouver
State : British Columbia
Zip Code : V5Z 3J5
Country : Canada
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State : New Brunswick
Zip Code : E2M 3W5
Country : Canada
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City : Bay Roberts
State : Newfoundland and Labrador
Zip Code : A0A 1G0
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Facility Name : GSK Clinical Trials Call Center
City : Gatineau
State : Quebec
Zip Code : J8Y 6S9
Country : Canada
OutComes
Primary OutComes
Measure : Rate of moderate/severe exacerbations over a 52 week treatment period
Secondary OutComes
Measure : The time until the first moderate/severe exacerbation; the annual rate of exacerbations requiring oral corticosteroid treatment, and breathing tests conducted over one year
Interventions
Type : Drug
Name : Fluticasone Propionate/Salmeterol Combination Product
Type : Drug
Name : Salmeterol
 
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