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

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.

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Key information

Conditions

Bronchospasm Activity/Exercise Induced Bronchospasm Asthma Asthma, Exercise-Induced Behavior Bronchial Diseases Bronchial Spasm Exercise-Induced Allergies Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Motor Activity Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

GSK Investigational Site, Jonesboro, Arkansas, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fluticasone propionate/salmeterol

Drug

Primary outcomes

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 outcomes

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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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 DISKUS 100mcg BID in Pediatric and Adolescent Subjects With Activity-Induced Bronchospasm

Important dates

Study start: 2003
Primary completion: 2005
Study completion: 2005
First posted: Jul 12, 2005
Registry last updated: Sep 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed