Clinical trial NCT00118716: 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: asthma
bronchospasm
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-07-12
Enrollment: 248
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.
* Experienced worsened asthma symptoms during physical activity.
* Using an inhaled steroid for the previous 4 weeks or longer (such as Aerobid, Azmacort, Flovent, Pulmicort, QVAR, and Vanceril).

Exclusion criteria:

* Used systemic steroids as either liquids, pills, or injections to treat asthma within the previous 3 months.
* Have only intermittent, seasonal, or exercise-induced asthma, and not persistent asthma.
* Admitted to a hospital within the previous 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: Maximal Percent Change in Forced Expiratory Volume in 1 Second (FEV1) Following Exercise Challenge at Week 4
timeFrame: Baseline and Week 4
Secondary outcomes:
measure: Four-hour Serial Post-dose FEV1 Area Under the Curve (AUC) on Treatment Day 1
timeFrame: Immediately prior to dosing (0 time point), 30 minutes post-dose and 1, 2, 3, 4 hour post-dose on Day 1
measure: Change From Baseline in Morning Peak Expiratory Flow (AM PEF)
timeFrame: Baseline and Up to Week 4
measure: Change From Baseline in Evening (PM) PEF
timeFrame: Baseline and up to Week 4
measure: Percent of Rescue-free Days
timeFrame: Up to Week 4
measure: Percent of Symptom-free Days
timeFrame: Up to Week 4
measure: Change From Baseline in Pediatric Asthma Quality of Life Questionnaire (PAQLQ)
timeFrame: Baseline (Week 0) and up to Week 4
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Huntington Beach
country: United States
facility: GSK Investigational Site
state: California
city: Orange
country: United States
facility: GSK Investigational Site
state: California
city: Palmdale
country: United States
facility: GSK Investigational Site
state: California
city: Paramount
country: United States
facility: GSK Investigational Site
state: California
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: Torrance
country: United States
facility: GSK Investigational Site
state: California
city: Walnut Creek
country: United States
facility: GSK Investigational Site
state: California
city: Centennial
country: United States
facility: GSK Investigational Site
state: Colorado
city: Englewood
country: United States
facility: GSK Investigational Site
state: Colorado
city: Lakewood
country: United States
facility: GSK Investigational Site
state: Colorado
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Tallahassee
country: United States
facility: GSK Investigational Site
state: Florida
city: Lilburn
country: United States
facility: GSK Investigational Site
state: Georgia
city: Chicago
country: United States
facility: GSK Investigational Site
state: Illinois
city: Hoffman Estates
country: United States
facility: GSK Investigational Site
state: Illinois
city: Metairie
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Metairie
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Baltimore
country: United States
facility: GSK Investigational Site
state: Maryland
city: Glen Burnie
country: United States
facility: GSK Investigational Site
state: Maryland
city: North Dartmouth
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Minneapolis
country: United States
facility: GSK Investigational Site
state: Minnesota
city: Papillion
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Skillman
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Summit
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Commack
country: United States
facility: GSK Investigational Site
state: New York
city: Utica
country: United States
facility: GSK Investigational Site
state: New York
city: Canton
country: United States
facility: GSK Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: GSK Investigational Site
state: Ohio
city: Dayton
country: United States
facility: GSK Investigational Site
state: Ohio
city: Gresham
country: United States
facility: GSK Investigational Site
state: Oregon
city: Medford
country: United States
facility: GSK Investigational Site
state: Oregon
city: Portland
country: United States
facility: GSK Investigational Site
state: Oregon
city: Erie
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Hershey
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Pittsburgh
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: Dyersburg
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Knoxville
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Murray
country: United States
facility: GSK Investigational Site
state: Utah
city: Richmond
country: United States
facility: GSK Investigational Site
state: Virginia
city: Greenfield
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Madison
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Milwaukee
country: United States
facility: GSK Investigational Site
state: Wisconsin
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Pearlman D, Qaqundah P, Matz J, Yancey SW, Stempel DA, Ortega HG. Fluticasone propionate/salmeterol and exercise-induced asthma in children with persistent asthma. Pediatr Pulmonol. 2009 May;44(5):429-35. doi: 10.1002/ppul.20962.