Asthma Clinical Trial
Official title:
A Stratified, Randomized, Double-blind, Placebo-controlled, Parallel-group, 12 Week Trial Evaluating the Safety and Efficacy of Fluticasone Propionate/Salmeterol DISKUS Combination Product 100/50mcg Once Daily Versus Fluticasone Propionate DISKUS 100mcg Once Daily and Placebo in Symptomatic Pediatric Subjects (4-11 Years) With Asthma
| Verified date | September 2016 |
| Source | GlaxoSmithKline |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
To demonstrate if once-daily dosing of ADVAIR 100/50 once-daily has superior efficacy and comparable safety compared with FP 100mcg once-daily in pediatric subjects 4 to 11 years of age with asthma.
| Status | Completed |
| Enrollment | 908 |
| Est. completion date | January 2004 |
| Est. primary completion date | January 2004 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 4 Years to 11 Years |
| Eligibility |
Inclusion Criteria: - Out-patients - Asthma diagnosis - Reversibility - Short-acting beta-agonist or asthma controlled medication use Exclusion Criteria: - Life-threatening asthma - Specified asthma medications - Chickenpox - Drug allergy - Respiratory infections - Tobacco use - Clinical laboratory abnormalities - Ophthalmologic conditions - Investigation medications - Affiliation with investigator site |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Argentina | GSK Investigational Site | Buenos Aires | |
| Argentina | GSK Investigational Site | Ciudad Autónoma de Buenos Aires | |
| Argentina | GSK Investigational Site | Santa Fe | |
| Chile | GSK Investigational Site | Santiago | Región Metro De Santiago |
| Chile | GSK Investigational Site | Viña del Mar | Valparaíso |
| Peru | GSK Investigational Site | Breña | |
| Puerto Rico | GSK Investigational Site | Ponce | |
| Puerto Rico | GSK Investigational Site | San Juan | |
| United States | GSK Investigational Site | Albuquerque | New Mexico |
| United States | GSK Investigational Site | Altamonte Springs | Florida |
| United States | GSK Investigational Site | Altoona | Pennsylvania |
| United States | GSK Investigational Site | Asheville | North Carolina |
| United States | GSK Investigational Site | Atlanta | Georgia |
| United States | GSK Investigational Site | Augusta | Georgia |
| United States | GSK Investigational Site | Austin | Texas |
| United States | GSK Investigational Site | Barnesville | Georgia |
| United States | GSK Investigational Site | Bend | Oregon |
| United States | GSK Investigational Site | Berlin | New Jersey |
| United States | GSK Investigational Site | Beverly Hills | California |
| United States | GSK Investigational Site | Blue Belle | Pennsylvania |
| United States | GSK Investigational Site | Brick | New Jersey |
| United States | GSK Investigational Site | Buffalo | New York |
| United States | GSK Investigational Site | Burke | Virginia |
| United States | GSK Investigational Site | Canton | Ohio |
| United States | GSK Investigational Site | Centennial | Colorado |
| United States | GSK Investigational Site | Charleston | South Carolina |
| United States | GSK Investigational Site | Charleston | West Virginia |
| United States | GSK Investigational Site | Charlotte | North Carolina |
| 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 | Colorado Springs | Colorado |
| United States | GSK Investigational Site | Columbia | Missouri |
| United States | GSK Investigational Site | Covington | Louisiana |
| United States | GSK Investigational Site | Crescent City | California |
| United States | GSK Investigational Site | Dallas | Texas |
| United States | GSK Investigational Site | Denver | Colorado |
| United States | GSK Investigational Site | Denver | Colorado |
| United States | GSK Investigational Site | Denver | Colorado |
| United States | GSK Investigational Site | Detroit | Michigan |
| United States | GSK Investigational Site | Dinuba | California |
| United States | GSK Investigational Site | Durham | North Carolina |
| United States | GSK Investigational Site | East Orange | New Jersey |
| United States | GSK Investigational Site | Edmonds | Washington |
| United States | GSK Investigational Site | El Paso | Texas |
| United States | GSK Investigational Site | El Paso | Texas |
| United States | GSK Investigational Site | Elizabeth City | North Carolina |
| United States | GSK Investigational Site | Fresno | California |
| United States | GSK Investigational Site | Galveston | Texas |
| United States | GSK Investigational Site | Glenview | Illinois |
| United States | GSK Investigational Site | Greenfield | Wisconsin |
| United States | GSK Investigational Site | Greenville | South Carolina |
| United States | GSK Investigational Site | Harrisburg | Pennsylvania |
| United States | GSK Investigational Site | Hialeah | Florida |
| United States | GSK Investigational Site | Hoffman Estates | Illinois |
| United States | GSK Investigational Site | Houston | Texas |
| United States | GSK Investigational Site | Houston | Texas |
| United States | GSK Investigational Site | Houston | Texas |
| United States | GSK Investigational Site | Huntington Beach | California |
| United States | GSK Investigational Site | Indianapolis | Indiana |
| United States | GSK Investigational Site | Jacksonville | Florida |
| United States | GSK Investigational Site | Kansas City | Missouri |
| United States | GSK Investigational Site | Knoxville | Tennessee |
| United States | GSK Investigational Site | Knoxville | Tennessee |
| United States | GSK Investigational Site | Knoxville | Tennessee |
| United States | GSK Investigational Site | La Crosse | Wisconsin |
| United States | GSK Investigational Site | La Jolla | California |
| United States | GSK Investigational Site | Lake Jackson | Texas |
| United States | GSK Investigational Site | Lawrence | Kansas |
| United States | GSK Investigational Site | Layton | Utah |
| United States | GSK Investigational Site | Lewisburg | Pennsylvania |
| United States | GSK Investigational Site | Lincoln | Rhode Island |
| United States | GSK Investigational Site | Little Rock | Arkansas |
| United States | GSK Investigational Site | Liverpool | New York |
| United States | GSK Investigational Site | Long Beach | California |
| United States | GSK Investigational Site | Louisville | Kentucky |
| United States | GSK Investigational Site | Martinez | Georgia |
| United States | GSK Investigational Site | Medford | Oregon |
| United States | GSK Investigational Site | Metairie | Louisiana |
| United States | GSK Investigational Site | Metairie | Louisiana |
| United States | GSK Investigational Site | Minneapolis | Minnesota |
| United States | GSK Investigational Site | Mission Viejo | California |
| United States | GSK Investigational Site | Missoula | Montana |
| United States | GSK Investigational Site | Mount Pleasant | South Carolina |
| United States | GSK Investigational Site | Murray | Utah |
| United States | GSK Investigational Site | Murray | Kentucky |
| United States | GSK Investigational Site | New Braunfels | Texas |
| United States | GSK Investigational Site | New Hyde Park | New York |
| United States | GSK Investigational Site | Newport Beach | California |
| United States | GSK Investigational Site | Newton | Massachusetts |
| United States | GSK Investigational Site | Norfolk | Virginia |
| United States | GSK Investigational Site | North Dartmouth | Massachusetts |
| United States | GSK Investigational Site | Ocean | New Jersey |
| United States | GSK Investigational Site | Oklahoma City | Oklahoma |
| United States | GSK Investigational Site | Oklahoma City | Oklahoma |
| United States | GSK Investigational Site | Omaha | Nebraska |
| United States | GSK Investigational Site | Omaha | Nebraska |
| United States | GSK Investigational Site | Orange | California |
| United States | GSK Investigational Site | Orlando | Florida |
| United States | GSK Investigational Site | Orlando | Florida |
| United States | GSK Investigational Site | Ozark | Alabama |
| United States | GSK Investigational Site | Palmdale | California |
| United States | GSK Investigational Site | Panorama City | California |
| United States | GSK Investigational Site | Papillion | Nebraska |
| United States | GSK Investigational Site | Paramount | California |
| United States | GSK Investigational Site | Park Ridge | Illinois |
| United States | GSK Investigational Site | Philadelphia | Pennsylvania |
| United States | GSK Investigational Site | Pittsburgh | Pennsylvania |
| United States | GSK Investigational Site | Pittsburgh | Pennsylvania |
| United States | GSK Investigational Site | Plano | Texas |
| United States | GSK Investigational Site | Portland | Oregon |
| United States | GSK Investigational Site | Portland | Oregon |
| United States | GSK Investigational Site | Pueblo | Colorado |
| 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 | Rockville Center | New York |
| United States | GSK Investigational Site | Rolling Hills Estates | California |
| United States | GSK Investigational Site | San Antonio | Texas |
| 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 Francisco | California |
| United States | GSK Investigational Site | San Jose | California |
| United States | GSK Investigational Site | Sarasota | Florida |
| United States | GSK Investigational Site | Savannah | Georgia |
| United States | GSK Investigational Site | Sherman Oaks | California |
| United States | GSK Investigational Site | Shreveport | Louisiana |
| United States | GSK Investigational Site | South Bend | Indiana |
| United States | GSK Investigational Site | Spartanburg | South Carolina |
| United States | GSK Investigational Site | St. Louis | Missouri |
| United States | GSK Investigational Site | St. Louis | Missouri |
| United States | GSK Investigational Site | St. Louis | Missouri |
| United States | GSK Investigational Site | St. Petersburg | Florida |
| United States | GSK Investigational Site | Sunset | Louisiana |
| United States | GSK Investigational Site | Tacoma | Washington |
| United States | GSK Investigational Site | Tallahassee | Florida |
| United States | GSK Investigational Site | Tampa | Florida |
| United States | GSK Investigational Site | Taunton | Massachusetts |
| United States | GSK Investigational Site | Tucson | Arizona |
| United States | GSK Investigational Site | Tucson | Arizona |
| United States | GSK Investigational Site | Upland | Pennsylvania |
| United States | GSK Investigational Site | Verona | New Jersey |
| United States | GSK Investigational Site | Vestal | New York |
| United States | GSK Investigational Site | Vista | California |
| United States | GSK Investigational Site | Vista | California |
| United States | GSK Investigational Site | Walnut Creek | California |
| United States | GSK Investigational Site | West Quincy | Massachusetts |
| United States | GSK Investigational Site | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| GlaxoSmithKline |
United States, Argentina, Chile, Peru, Puerto Rico,
This study has not been published in the scientific literature.
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from baseline at endpoint in daily PM PEF | 12 weeks | No | |
| Secondary | Various pulmonary function endpoints | 12 weeks | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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