Overview

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

Status:
Completed
Trial end date:
2005-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
GlaxoSmithKline
Treatments:
Fluticasone
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Salmeterol Xinafoate
Xhance
Criteria
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.