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

Status:	Completed
Conditions:	Asthma, Pulmonary
Therapuetic Areas:	Pulmonary / Respiratory Diseases
Healthy:	No
Age Range:	4 - 17
Updated:	2/7/2019
Start Date:	December 23, 2003
End Date:	April 23, 2006

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

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.

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.

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

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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

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