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; Drug: Fluticasone Propionate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00118716

SFA100314

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: 248 patients

Sex: All

Ages: 4 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with persistent asthma for 3 months or longer.
• Experienced worsened asthma symptoms during physical activity.
• Using an inhaled steroid for the previous 4 weeks or longer (such as Aerobid, Azmacort, Flovent, Pulmicort, QVAR, and Vanceril).

Exclusion criteria

• Used systemic steroids as either liquids, pills, or injections to treat asthma within the previous 3 months.
• Have only intermittent, seasonal, or exercise-induced asthma, and not persistent asthma.
• Admitted to a hospital within the previous 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.

Trial design

248 participants in 2 patient groups

FSC 100/50 mcg BID

Experimental group

Description:

Participants received FSC 100/50 microgram (mcg) one inhalation as a combination product via DISKUS, twice daily in morning after awakening and in evening for up to 28 days

Treatment:

Drug: Fluticasone propionate/salmeterol

FP 100 mcg BID

Experimental group

Description:

Participants received FP 100 mcg one inhalation via DISKUS, twice daily in morning after awakening and in evening for up to 28 days.

Treatment:

Drug: Fluticasone Propionate