NCT00118716

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 248 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 4 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bronchospasm
• Activity/Exercise Induced Bronchospasm

Interventions

Type	Name	Description
DRUG	Fluticasone propionate/salmeterol	Fluticasone propionate/salmeterol
DRUG	Fluticasone Propionate	Fluticasone Propionate

Timeline

• Start date: 2003-12-23
• Primary completion: 2006-04-01
• Completion: 2006-04-23
• First posted: 2005-07-12
• Last updated: 2019-02-05
• Results posted: 2019-02-05

Locations

50 sites across 1 country: United States