Asthma Clinical Trial
Official title:
A Multicenter, Randomized, Double-Blind, Parallel Group, 52-Week Comparison of Asthma Control and Measures of Airway Inflammation in Subjects of African Descent Receiving Fluticasone Propionate/Salmeterol 100/50mcg DISKUS® BID or Fluticasone Propionate 100mcg DISKUS® BID Alone
| Verified date | January 2017 |
| Source | GlaxoSmithKline |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study will last up to 62 weeks. You will visit the clinic up to 17 times. Certain clinic visits will include physical examination, medical history review and lung function tests. The purpose of this study is to see if one asthma drug (fluticasone propionate/salmeterol) is better in reducing the number of asthma exacerbations compared with another drug (fluticasone propionate alone)
| Status | Completed |
| Enrollment | 479 |
| Est. completion date | April 2007 |
| Est. primary completion date | April 2007 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 12 Years to 65 Years |
| Eligibility |
Inclusion criteria: - History of asthma for at least 6 months. - Taking a low-dose of an inhaled corticosteroid for at least one month prior to the study (such as fluticasone propionate or budesonide). Exclusion criteria: - History of life-threatening asthma. - Hospitalized for asthma within 3 months prior to the study. - Current respiratory tract infection. - Will not be able to attend clinic visits for the entire length of the study. - Certain medical conditions that will make being in the study unsafe (such as congestive heart failure, uncontrolled hypertension, tuberculosis or certain drug allergies). |
| Country | Name | City | State |
|---|---|---|---|
| United States | GSK Investigational Site | Atlanta | Georgia |
| United States | GSK Investigational Site | Austin | Texas |
| United States | GSK Investigational Site | Baltimore | Maryland |
| United States | GSK Investigational Site | Bethesda | Maryland |
| United States | GSK Investigational Site | Birmingham | Alabama |
| 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 | Brooklyn | New York |
| United States | GSK Investigational Site | Chapel Hill | North Carolina |
| United States | GSK Investigational Site | Charleston | South Carolina |
| United States | GSK Investigational Site | Charleston | South Carolina |
| United States | GSK Investigational Site | Charlotte | North Carolina |
| United States | GSK Investigational Site | Chattanooga | Tennessee |
| United States | GSK Investigational Site | Chicago | Illinois |
| United States | GSK Investigational Site | Cincinnati | Ohio |
| United States | GSK Investigational Site | Cleveland | Ohio |
| United States | GSK Investigational Site | Columbus | Georgia |
| United States | GSK Investigational Site | Dallas | Texas |
| United States | GSK Investigational Site | Dallas | Texas |
| United States | GSK Investigational Site | Decatur | Georgia |
| United States | GSK Investigational Site | Detroit | Michigan |
| United States | GSK Investigational Site | Durham | North Carolina |
| United States | GSK Investigational Site | Elizabeth City | North Carolina |
| United States | GSK Investigational Site | Flossmoor | Illinois |
| United States | GSK Investigational Site | Greenville | South Carolina |
| United States | GSK Investigational Site | Hartford | Connecticut |
| United States | GSK Investigational Site | High Point | North Carolina |
| United States | GSK Investigational Site | Houston | Texas |
| United States | GSK Investigational Site | Jackson | Mississippi |
| United States | GSK Investigational Site | Jacksonville | Florida |
| United States | GSK Investigational Site | Jenkintown | Pennsylvania |
| United States | GSK Investigational Site | Knoxville | Tennessee |
| United States | GSK Investigational Site | Knoxville | Tennessee |
| United States | GSK Investigational Site | Lafayette | Louisiana |
| United States | GSK Investigational Site | Little Rock | Arkansas |
| United States | GSK Investigational Site | Little Rock | Arkansas |
| United States | GSK Investigational Site | Long Beach | California |
| United States | GSK Investigational Site | Los Angeles | California |
| United States | GSK Investigational Site | Madison | Wisconsin |
| United States | GSK Investigational Site | Martinez | Georgia |
| United States | GSK Investigational Site | Metairie | Louisiana |
| United States | GSK Investigational Site | Minneapolis | Minnesota |
| United States | GSK Investigational Site | Mobile | Alabama |
| United States | GSK Investigational Site | Montgomery | Alabama |
| United States | GSK Investigational Site | Muscle Shoals | Alabama |
| United States | GSK Investigational Site | Nashville | Tennessee |
| United States | GSK Investigational Site | Nashville | Tennessee |
| United States | GSK Investigational Site | New York | New York |
| United States | GSK Investigational Site | Newport News | Virginia |
| United States | GSK Investigational Site | Norfolk | Virginia |
| United States | GSK Investigational Site | Oklahoma City | Oklahoma |
| United States | GSK Investigational Site | Orangeburg | South Carolina |
| United States | GSK Investigational Site | Palmdale | California |
| United States | GSK Investigational Site | Philadelphia | Pennsylvania |
| United States | GSK Investigational Site | Philadelphia | Pennsylvania |
| United States | GSK Investigational Site | Philadelphia | Pennsylvania |
| United States | GSK Investigational Site | Picayune | Mississippi |
| United States | GSK Investigational Site | Richmond | Virginia |
| United States | GSK Investigational Site | Richmond | Virginia |
| United States | GSK Investigational Site | Riverside | California |
| United States | GSK Investigational Site | San Francisco | California |
| United States | GSK Investigational Site | Savannah | Georgia |
| United States | GSK Investigational Site | St. Louis | Missouri |
| United States | GSK Investigational Site | Stockton | California |
| United States | GSK Investigational Site | Sunset | Louisiana |
| United States | GSK Investigational Site | Sylvania | Ohio |
| United States | GSK Investigational Site | Tallahassee | Florida |
| United States | GSK Investigational Site | Verona | New Jersey |
| United States | GSK Investigational Site | Walnut Creek | California |
| United States | GSK Investigational Site | Washington | District of Columbia |
| United States | GSK Investigational Site | Washington | District of Columbia |
| United States | GSK Investigational Site | West Sayville | New York |
| United States | GSK Investigational Site | Winston-Salem | North Carolina |
| United States | GSK Investigational Site | Ypsilanti | Michigan |
| Lead Sponsor | Collaborator |
|---|---|
| GlaxoSmithKline |
United States,
Bailey W, Castro M, Matz J, White M, Dransfield M, Yancey S, Ortega H. Asthma exacerbations in African Americans treated for 1 year with combination fluticasone propionate and salmeterol or fluticasone propionate alone. Curr Med Res Opin. 2008 Jun;24(6):1669-82. doi: 10.1185/03007990802119111. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Asthma exacerbation rate per patient per year | |||
| Secondary | Morning peak flow measurement, percent of asthma symptom-free days, percent of albuterol-free days |
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