Pulmonary Disease, Chronic Obstructive Clinical Trial
Official 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)
Verified date | October 2016 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 740 |
Est. completion date | December 2006 |
Est. primary completion date | December 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | GSK Investigational Site | Calgary | Alberta |
Canada | GSK Investigational Site | Cowansville | Quebec |
Canada | GSK Investigational Site | Grimsby | Ontario |
Canada | GSK Investigational Site | La Malbaie | Quebec |
Canada | GSK Investigational Site | Montreal | Quebec |
Canada | GSK Investigational Site | Saint Leonard | Quebec |
Canada | GSK Investigational Site | Sainte Jerome | Quebec |
Canada | GSK Investigational Site | Sainte-Foy | Quebec |
Canada | GSK Investigational Site | Sherbrooke | Quebec |
Canada | GSK Investigational Site | Sorel | Quebec |
Canada | GSK Investigational Site | Toronto | Ontario |
Canada | GSK Investigational Site | Winnipeg | Manitoba |
United States | GSK Investigational Site | Abingdon | Virginia |
United States | GSK Investigational Site | Albuquerque | New Mexico |
United States | GSK Investigational Site | Auburn | Maine |
United States | GSK Investigational Site | Birmingham | Alabama |
United States | GSK Investigational Site | Birmingham | Alabama |
United States | GSK Investigational Site | Boston | Massachusetts |
United States | GSK Investigational Site | Bristol | Tennessee |
United States | GSK Investigational Site | Champaign | Illinois |
United States | GSK Investigational Site | Charleston | South Carolina |
United States | GSK Investigational Site | Charlottesville | Virginia |
United States | GSK Investigational Site | Cherry Hill | New Jersey |
United States | GSK Investigational Site | Chicago | Illinois |
United States | GSK Investigational Site | Cincinnati | Ohio |
United States | GSK Investigational Site | Cincinnati | Ohio |
United States | GSK Investigational Site | Cleveland | Ohio |
United States | GSK Investigational Site | Coeur D'Alene | Idaho |
United States | GSK Investigational Site | Colorado Springs | Colorado |
United States | GSK Investigational Site | Columbus | Ohio |
United States | GSK Investigational Site | Corona | California |
United States | GSK Investigational Site | Corsicana | Texas |
United States | GSK Investigational Site | Cumberland | Rhode Island |
United States | GSK Investigational Site | Deland | Florida |
United States | GSK Investigational Site | Denver | Colorado |
United States | GSK Investigational Site | Denver | Colorado |
United States | GSK Investigational Site | Des Moines | Iowa |
United States | GSK Investigational Site | Elizabeth City | North Carolina |
United States | GSK Investigational Site | Englewood | Colorado |
United States | GSK Investigational Site | Eugene | Oregon |
United States | GSK Investigational Site | Evansville | Indiana |
United States | GSK Investigational Site | Fort Worth | Texas |
United States | GSK Investigational Site | Gig Harbor | Washington |
United States | GSK Investigational Site | Glendale | Arizona |
United States | GSK Investigational Site | Greer | South Carolina |
United States | GSK Investigational Site | Houston | Texas |
United States | GSK Investigational Site | Jacksonville | Florida |
United States | GSK Investigational Site | Jasper | Alabama |
United States | GSK Investigational Site | Johnson City | Tennessee |
United States | GSK Investigational Site | Kalamazoo | Michigan |
United States | GSK Investigational Site | Kansas City | Missouri |
United States | GSK Investigational Site | Lafayette | Louisiana |
United States | GSK Investigational Site | Larchmont | New York |
United States | GSK Investigational Site | Largo | Florida |
United States | GSK Investigational Site | Lewistown | New York |
United States | GSK Investigational Site | Little Rock | Arkansas |
United States | GSK Investigational Site | Los Angeles | California |
United States | GSK Investigational Site | Medford | Oregon |
United States | GSK Investigational Site | Minneapolis | Minnesota |
United States | GSK Investigational Site | Morgantown | West Virginia |
United States | GSK Investigational Site | Newport News | Virginia |
United States | GSK Investigational Site | North Miami Beach | Florida |
United States | GSK Investigational Site | Omaha | Nebraska |
United States | GSK Investigational Site | Omaha | Nebraska |
United States | GSK Investigational Site | Palmdale | California |
United States | GSK Investigational Site | Paramount | California |
United States | GSK Investigational Site | Pensacola | Florida |
United States | GSK Investigational Site | Peoria | Illinois |
United States | GSK Investigational Site | Philadelphia | Pennsylvania |
United States | GSK Investigational Site | Phoenix | Arizona |
United States | GSK Investigational Site | Pittsburgh | Pennsylvania |
United States | GSK Investigational Site | Portland | Oregon |
United States | GSK Investigational Site | Providence | Rhode Island |
United States | GSK Investigational Site | Raleigh | North Carolina |
United States | GSK Investigational Site | Rancho Mirage | California |
United States | GSK Investigational Site | Riverside | California |
United States | GSK Investigational Site | Rochester | Minnesota |
United States | GSK Investigational Site | Sacramento | California |
United States | GSK Investigational Site | San Antonio | Texas |
United States | GSK Investigational Site | San Diego | California |
United States | GSK Investigational Site | Scottsdale | Arizona |
United States | GSK Investigational Site | Sepulveda | California |
United States | GSK Investigational Site | Simpsonville | South Carolina |
United States | GSK Investigational Site | Slidell | Louisiana |
United States | GSK Investigational Site | South Bend | Indiana |
United States | GSK Investigational Site | Spartanburg | South Carolina |
United States | GSK Investigational Site | Spokane | Washington |
United States | GSK Investigational Site | St. Charles | Missouri |
United States | GSK Investigational Site | St. Louis | Missouri |
United States | GSK Investigational Site | Statesville | North Carolina |
United States | GSK Investigational Site | Stockton | California |
United States | GSK Investigational Site | Summit | New Jersey |
United States | GSK Investigational Site | Tampa | Florida |
United States | GSK Investigational Site | Toledo | Ohio |
United States | GSK Investigational Site | Tulsa | Oklahoma |
United States | GSK Investigational Site | Wheat Ridge | Colorado |
United States | GSK Investigational Site | Worcester | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
United States, Canada,
Ferguson GT, Anzueto A, Fei R, Emmett A, Knobil K, Kalberg C. Effect of fluticasone propionate/salmeterol (250/50 microg) or salmeterol (50 microg) on COPD exacerbations. Respir Med. 2008 Aug;102(8):1099-108. doi: 10.1016/j.rmed.2008.04.019. Epub 2008 Jul 9. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of moderate/severe exacerbations over a 52 week treatment period. | |||
Secondary | The time until the first moderate/severe exacerbation, the annual rate of exacerbations requiring oral corticosteroid treatment, and breathing tests conducted over one year. |
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