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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 DISKU

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.

Detailed Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome: 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.

Original Primary Outcome: Same as current

Current Secondary Outcome: Daily lung function tests and subject assessed diary measures analyzed over the 4-week treatment.

Original Secondary Outcome: Same as current

Information By: GlaxoSmithKline

Dates:
Date Received: July 1, 2005
Date Started: December 2003
Date Completion:
Last Updated: September 22, 2016
Last Verified: September 2016