Bronchospasm Clinical Trial
Official title:
A Stratified, Multicenter, Randomized, Double-Blind, Parallel Group, 4-Week Comparison of Fluticasone Propionate/Salmeterol DISKUS Combination Product 100/50mcg BID Versus Fluticasone Propionate DISKUS 100mcg BID in Pediatric and Adolescent Subjects With Activity-Induced Bronchospasm
| Verified date | September 2016 |
| Source | GlaxoSmithKline |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
During this study, your child will need to attend up to 5 office visits and maintain regular telephone contact with the clinic. Certain office visits will include physical exams, medical history review, exercise challenge test (walking/running on a treadmill), electrocardiogram (ECG) tests, and lung function tests. All study related medications and medical examinations are provided at no cost. All study drugs are currently available by prescription to patients 4 years and older.
| Status | Completed |
| Enrollment | 227 |
| Est. completion date | December 2005 |
| Est. primary completion date | December 2005 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 4 Years to 17 Years |
| Eligibility |
Inclusion criteria: - Diagnosed with persistent asthma for 3 months or longer. - Experience worsened asthma symptoms during physical activity. - Using or used an inhaled steroid for the last 4 weeks or longer (such as Aerobid, Azmacort, Flovent, Pulmicort, QVAR, or Vanceril). Exclusion criteria: - Used systemic steroids as either liquids, pills, or injections to treat asthma within the last 3 months. - Have only intermittent, seasonal, or exercise induced asthma, and not persistent asthma. - Admitted to a hospital within the last 6 months due to asthma symptoms. - Any poorly controlled medical conditions that may make study participation unsafe or inappropriate in the opinion of the study physician (such as cystic fibrosis, congenital heart disease, insulin dependent diabetes, glaucoma, drug allergies, etc.). - The study physician will evaluate other medical criteria. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | GSK Investigational Site | Altamonte Springs | Florida |
| United States | GSK Investigational Site | Altoona | Pennsylvania |
| United States | GSK Investigational Site | Bethesda | Maryland |
| United States | GSK Investigational Site | Boston | Massachusetts |
| United States | GSK Investigational Site | Burke | Virginia |
| United States | GSK Investigational Site | Charleston | South Carolina |
| United States | GSK Investigational Site | Dallas | Texas |
| United States | GSK Investigational Site | Delray Beach | Florida |
| United States | GSK Investigational Site | Denver | Colorado |
| United States | GSK Investigational Site | East Artesia | California |
| United States | GSK Investigational Site | El Paso | Texas |
| United States | GSK Investigational Site | El Paso | Texas |
| United States | GSK Investigational Site | Englewood | Colorado |
| United States | GSK Investigational Site | Houston | Texas |
| United States | GSK Investigational Site | Huntington Beach | California |
| United States | GSK Investigational Site | Iowa City | Iowa |
| United States | GSK Investigational Site | Jonesboro | Arkansas |
| United States | GSK Investigational Site | Kernersville | North Carolina |
| United States | GSK Investigational Site | Lawrenceville | Georgia |
| United States | GSK Investigational Site | Layton | Utah |
| United States | GSK Investigational Site | Long Beach | California |
| United States | GSK Investigational Site | Los Angeles | California |
| United States | GSK Investigational Site | Louisville | Kentucky |
| United States | GSK Investigational Site | Madera | California |
| United States | GSK Investigational Site | Marietta | Georgia |
| United States | GSK Investigational Site | Medford | Oregon |
| United States | GSK Investigational Site | Mission Viejo | California |
| United States | GSK Investigational Site | Missoula | Montana |
| United States | GSK Investigational Site | Mount Laurel | New Jersey |
| United States | GSK Investigational Site | Mount Pleasant | South Carolina |
| United States | GSK Investigational Site | Nashville | Tennessee |
| United States | GSK Investigational Site | Normal | Illinois |
| United States | GSK Investigational Site | Oakland | California |
| United States | GSK Investigational Site | Oklahoma City | Oklahoma |
| United States | GSK Investigational Site | Omaha | Nebraska |
| United States | GSK Investigational Site | Orangeburg | South Carolina |
| United States | GSK Investigational Site | Pittsburgh | Pennsylvania |
| United States | GSK Investigational Site | Provo | Utah |
| United States | GSK Investigational Site | Pueblo | Colorado |
| United States | GSK Investigational Site | Robbinsdale | Minnesota |
| United States | GSK Investigational Site | Rolling Hills Est | California |
| United States | GSK Investigational Site | San Antonio | Texas |
| United States | GSK Investigational Site | Savannah | Georgia |
| United States | GSK Investigational Site | Savannah | Georgia |
| United States | GSK Investigational Site | South Burlington | Vermont |
| United States | GSK Investigational Site | St. Petersburg | Florida |
| United States | GSK Investigational Site | Sunset | Louisiana |
| United States | GSK Investigational Site | Tampa | Florida |
| United States | GSK Investigational Site | Tampa | Florida |
| United States | GSK Investigational Site | Upland | Pennsylvania |
| United States | GSK Investigational Site | Vista | California |
| Lead Sponsor | Collaborator |
|---|---|
| GlaxoSmithKline |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in maximal decline from baseline in lung function following exercise challenge after 4-weeks of double-blind treatment compared to decline in lung function before treatment. | No | ||
| Secondary | Daily lung function tests and subject assessed diary measures analyzed over the 4-week treatment. | No |
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