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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 4

Conditions

Activity/Exercise Induced Bronchospasm

Bronchospasm

Treatments

Drug: Fluticasone propionate/salmeterol

Study type

Interventional

Funder types

Industry

Identifiers

NCT00118690

SFA100316

Details and patient eligibility

About

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.

Enrollment

227 patients

Sex

All

Ages

4 to 17 years old

Volunteers

No Healthy Volunteers

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.