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 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
Verified date | January 2017 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
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 FDA for use in patients with COPD.
Status | Completed |
Enrollment | 797 |
Est. completion date | June 2007 |
Est. primary completion date | June 2007 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Canada | GSK Investigational Site | Bay Roberts | Newfoundland and Labrador |
Canada | GSK Investigational Site | Bonaventure | Quebec |
Canada | GSK Investigational Site | Chandler | Quebec |
Canada | GSK Investigational Site | Charlesbourg | Quebec |
Canada | GSK Investigational Site | Gatineau | Quebec |
Canada | GSK Investigational Site | Grimsby | Ontario |
Canada | GSK Investigational Site | Holyrood | Newfoundland and Labrador |
Canada | GSK Investigational Site | London | Ontario |
Canada | GSK Investigational Site | Saint John | New Brunswick |
Canada | GSK Investigational Site | Saint Leonard | Quebec |
Canada | GSK Investigational Site | Sherbrooke | Quebec |
Canada | GSK Investigational Site | Thunder Bay | Ontario |
Canada | GSK Investigational Site | Trois Rivieres | Quebec |
Canada | GSK Investigational Site | Vancouver | British Columbia |
Canada | GSK Investigational Site | Winnipeg | Manitoba |
United States | GSK Investigational Site | Abingdon | Virginia |
United States | GSK Investigational Site | Absecon | New Jersey |
United States | GSK Investigational Site | Albany | New York |
United States | GSK Investigational Site | Atlanta | Georgia |
United States | GSK Investigational Site | Atlantis | Florida |
United States | GSK Investigational Site | Auburn | Maine |
United States | GSK Investigational Site | Baltimore | Maryland |
United States | GSK Investigational Site | Bayshore | New York |
United States | GSK Investigational Site | Bellingham | Washington |
United States | GSK Investigational Site | Berkeley | California |
United States | GSK Investigational Site | Billings | Montana |
United States | GSK Investigational Site | Boston | Massachusetts |
United States | GSK Investigational Site | Bristol | Tennessee |
United States | GSK Investigational Site | Butte | Montana |
United States | GSK Investigational Site | Canton | Ohio |
United States | GSK Investigational Site | Chapel Hill | North Carolina |
United States | GSK Investigational Site | Chardon | Ohio |
United States | GSK Investigational Site | Charlotte | North Carolina |
United States | GSK Investigational Site | Chattanooga | Tennessee |
United States | GSK Investigational Site | Chesterfield | Missouri |
United States | GSK Investigational Site | Clear Water | Florida |
United States | GSK Investigational Site | Dallas | Texas |
United States | GSK Investigational Site | Deland | Florida |
United States | GSK Investigational Site | East Providence | Rhode Island |
United States | GSK Investigational Site | Elizabeth City | North Carolina |
United States | GSK Investigational Site | Elkhart | Indiana |
United States | GSK Investigational Site | Erie | Pennsylvania |
United States | GSK Investigational Site | Evansville | Indiana |
United States | GSK Investigational Site | Evansville | Indiana |
United States | GSK Investigational Site | Fort Collins | Colorado |
United States | GSK Investigational Site | Fort Lauderdale | Florida |
United States | GSK Investigational Site | Fullerton | California |
United States | GSK Investigational Site | Gaffney | South Carolina |
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 | Hershey | Pennsylvania |
United States | GSK Investigational Site | High Point | North Carolina |
United States | GSK Investigational Site | Houston | Texas |
United States | GSK Investigational Site | Indianapolis | Indiana |
United States | GSK Investigational Site | Iowa City | Iowa |
United States | GSK Investigational Site | Ithaca | New York |
United States | GSK Investigational Site | Jasper | Alabama |
United States | GSK Investigational Site | Jefferson City | Missouri |
United States | GSK Investigational Site | Johnson City | Tennessee |
United States | GSK Investigational Site | Kingsport | Tennessee |
United States | GSK Investigational Site | Kirkland | Washington |
United States | GSK Investigational Site | La Crosse | Wisconsin |
United States | GSK Investigational Site | Lafayette | Louisiana |
United States | GSK Investigational Site | Lake Oswego | Oregon |
United States | GSK Investigational Site | Larchmont | New York |
United States | GSK Investigational Site | Lynchburg | Virginia |
United States | GSK Investigational Site | Madisonville | Kentucky |
United States | GSK Investigational Site | McKeesport | Pennsylvania |
United States | GSK Investigational Site | Milwaukee | Wisconsin |
United States | GSK Investigational Site | Minneapolis | Minnesota |
United States | GSK Investigational Site | Mobile | Alabama |
United States | GSK Investigational Site | Mogadore | Ohio |
United States | GSK Investigational Site | Morgantown | West Virginia |
United States | GSK Investigational Site | New Braunfels | Texas |
United States | GSK Investigational Site | New Orleans | Louisiana |
United States | GSK Investigational Site | New York | New York |
United States | GSK Investigational Site | Newport News | Virginia |
United States | GSK Investigational Site | Olathe | Kansas |
United States | GSK Investigational Site | Omaha | Nebraska |
United States | GSK Investigational Site | Omaha | Nebraska |
United States | GSK Investigational Site | Pensacola | Florida |
United States | GSK Investigational Site | Phoenix | Arizona |
United States | GSK Investigational Site | Pittsburgh | Pennsylvania |
United States | GSK Investigational Site | Pittsburgh | Pennsylvania |
United States | GSK Investigational Site | Providence | Rhode Island |
United States | GSK Investigational Site | Raleigh | North Carolina |
United States | GSK Investigational Site | Richmond | Virginia |
United States | GSK Investigational Site | Riverside | California |
United States | GSK Investigational Site | Sacramento | California |
United States | GSK Investigational Site | San Antonio | Texas |
United States | GSK Investigational Site | San Antonio | Texas |
United States | GSK Investigational Site | San Diego | California |
United States | GSK Investigational Site | San Marcos | Texas |
United States | GSK Investigational Site | Sarasota | Florida |
United States | GSK Investigational Site | Shreveport | Louisiana |
United States | GSK Investigational Site | Simpsonville | South Carolina |
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 | Springfield | Illinois |
United States | GSK Investigational Site | St. Charles | Missouri |
United States | GSK Investigational Site | St. Joseph | Michigan |
United States | GSK Investigational Site | St. Louis | Missouri |
United States | GSK Investigational Site | Stamford | Connecticut |
United States | GSK Investigational Site | Sunset | Louisiana |
United States | GSK Investigational Site | Tamarac | Florida |
United States | GSK Investigational Site | Vista | California |
United States | GSK Investigational Site | Winston-Salem | North Carolina |
United States | GSK Investigational Site | Woodstock | Georgia |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
United States, Canada,
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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