drugset / Trial / NCT00118716

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

NCT00118716 ↗

Phase 4 Completed 248 enrolled GlaxoSmithKline
RandomizedParallel-groupTreatment

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.

Timeline

Start
2003-12-23
Primary completion
2006-04-01
Completion
2006-04-23

Outcome

Met primary endpoint

registry FSC 100/50mcg BID vs FP 100mcg BID; p = 0.021; Mean Difference (Net) 3.0 (95% CI 0.5 to 5.6); ANCOVA NCT00118716 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Fluticasone propionate Other / unclassified 100 ug Inhaled
Subject Salmeterol Other / unclassified 50 ug Inhaled