A Study Measuring Asthma Control In Pediatric And Adolescent Subjects Whose Asthma Is Worsened By Activity Or Exercise

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Bronchospasm, Activity/Exercise Induced Bronchospasm

Intervention / Treatment
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* Drug: Fluticasone propionate/salmeterol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Fluticasone propionate/salmeterol|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily lung function tests and subject assessed diary measures analyzed over the 4-week treatment. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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asthma, bronchospasm