Clinical trial NCT00118690: A Study Measuring Asthma Control In Pediatric And Adolescent Subjects Whose Asthma Is Worsened By Activity Or Exercise
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bronchospasm
Activity/Exercise Induced Bronchospasm
Keywords: bronchospasm
asthma
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-07-12
Enrollment: 227
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
Secondary outcomes:
measure: Daily lung function tests and subject assessed diary measures analyzed over the 4-week treatment.
Other outcomes:
Locations:
city: Jonesboro
country: United States
facility: GSK Investigational Site
state: Arkansas
city: East Artesia
country: United States
facility: GSK Investigational Site
state: California
city: Huntington Beach
country: United States
facility: GSK Investigational Site
state: California
city: Long Beach
country: United States
facility: GSK Investigational Site
state: California
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: Madera
country: United States
facility: GSK Investigational Site
state: California
city: Mission Viejo
country: United States
facility: GSK Investigational Site
state: California
city: Oakland
country: United States
facility: GSK Investigational Site
state: California
city: Rolling Hills Est
country: United States
facility: GSK Investigational Site
state: California
city: Vista
country: United States
facility: GSK Investigational Site
state: California
city: Denver
country: United States
facility: GSK Investigational Site
state: Colorado
city: Englewood
country: United States
facility: GSK Investigational Site
state: Colorado
city: Pueblo
country: United States
facility: GSK Investigational Site
state: Colorado
city: Altamonte Springs
country: United States
facility: GSK Investigational Site
state: Florida
city: Delray Beach
country: United States
facility: GSK Investigational Site
state: Florida
city: St. Petersburg
country: United States
facility: GSK Investigational Site
state: Florida
city: Tampa
country: United States
facility: GSK Investigational Site
state: Florida
city: Tampa
country: United States
facility: GSK Investigational Site
state: Florida
city: Lawrenceville
country: United States
facility: GSK Investigational Site
state: Georgia
city: Marietta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Savannah
country: United States
facility: GSK Investigational Site
state: Georgia
city: Savannah
country: United States
facility: GSK Investigational Site
state: Georgia
city: Normal
country: United States
facility: GSK Investigational Site
state: Illinois
city: Iowa City
country: United States
facility: GSK Investigational Site
state: Iowa
city: Louisville
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Sunset
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Bethesda
country: United States
facility: GSK Investigational Site
state: Maryland
city: Boston
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Robbinsdale
country: United States
facility: GSK Investigational Site
state: Minnesota
city: Missoula
country: United States
facility: GSK Investigational Site
state: Montana
city: Omaha
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Mount Laurel
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Kernersville
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Oklahoma City
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Medford
country: United States
facility: GSK Investigational Site
state: Oregon
city: Altoona
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Upland
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Mount Pleasant
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Orangeburg
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Nashville
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: El Paso
country: United States
facility: GSK Investigational Site
state: Texas
city: El Paso
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: Layton
country: United States
facility: GSK Investigational Site
state: Utah
city: Provo
country: United States
facility: GSK Investigational Site
state: Utah
city: South Burlington
country: United States
facility: GSK Investigational Site
state: Vermont
city: Burke
country: United States
facility: GSK Investigational Site
state: Virginia
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: