Phase 3
N=154
Two Investigational Drugs in the Prevention of Airway Constriction Brought on by Exercise in Participants With Asthma (0476-911)
Exercise Induced Asthma
Bottom Line
View on ClinicalTrials.gov: NCT00127166 ↗Enrolled (actual)
154
Serious AEs
0.7%
Results posted
Dec 2009
Primary outcome: Primary: Maximum Post-exercise Percent (%) Fall in FEV1 — 10.57; 13.82 Percent change from baseline — p=0.009
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Montelukast sodium (Drug); Salmeterol xinafoate (Drug); Fluticasone propionate (Drug); Montelukast matching placebo (Drug); Salmeterol matching placebo (Drug)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- Organon and Co
- Primary completion
- Nov 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Post-exercise Percent (%) Fall in FEV1 |
10.57; 13.82 | 0.009 sig |
| SECONDARY Area Under the Curve for %-Change From Pre-exercise Baseline FEV1 in Liters (L), From 0 to 20 Minutes (AUC(0-20)) |
116.04; 168.75 | 0.006 sig |
| SECONDARY Maximum FEV1 % Predicted Following First Beta-agonist Use |
104.03; 99.92 | <0.001 sig |
| SECONDARY Time to Recovery to Within 5% of Baseline FEV1 |
5.9; 11.1 | 0.035 sig |
| SECONDARY Average (Avg) %-Change in FEV1 After First Beta (β)-Agonist Use and Prior to Second β-agonist Use |
6.51; 2.72 | <0.001 sig |
Summary
The purpose of this study is to determine the effect of four weeks of treatment with two investigational drugs (oral versus inhaled administration) plus an inhaled medication in the treatment of airway constriction brought on by exercise in participants with asthma.
Eligibility Criteria
Inclusion Criteria
- 6-14 year old children with a history of asthma for at least 12 months
- must demonstrate airway constriction brought on by exercise
Exclusion Criteria
- is taking any medications that are not allowed in the study
Data sourced from ClinicalTrials.gov (NCT00127166). 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.