Phase 4
N=248
A Study Measuring Asthma Control In Pediatric And Adolescent Subjects Whose Asthma Is Worsened By Activity Or Exercise
Bronchospasm · Activity/Exercise Induced Bronchospasm
Bottom Line
View on ClinicalTrials.gov: NCT00118716 ↗Enrolled (actual)
248
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcome: Primary: Maximal Percent Change in Forced Expiratory Volume in 1 Second (FEV1) Following Exercise Challenge at Week 4 — -9.5; -12.7 Percent change — p=0.021
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Fluticasone propionate/salmeterol (Drug); Fluticasone Propionate (Drug)
- Age
- Pediatric · 4+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Apr 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximal Percent Change in Forced Expiratory Volume in 1 Second (FEV1) Following Exercise Challenge at Week 4 |
-9.5; -12.7 | 0.021 sig |
| SECONDARY Four-hour Serial Post-dose FEV1 Area Under the Curve (AUC) on Treatment Day 1 |
0.70; 0.30 | <0.001 sig |
| SECONDARY Change From Baseline in Morning Peak Expiratory Flow (AM PEF) |
16.3; 9.1 | 0.097 |
| SECONDARY Change From Baseline in Evening (PM) PEF |
10.8; 7.6 | 0.396 |
| SECONDARY Percent of Rescue-free Days |
59.4; 54.7 | — |
| SECONDARY Percent of Symptom-free Days |
27.3; 28.6 | — |
| SECONDARY Change From Baseline in Pediatric Asthma Quality of Life Questionnaire (PAQLQ) |
0.78; 0.63; 0.93; 0.75; 0.89; 0.67 | 0.168 |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00118716). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.