Phase 3
Completed N=421
Montelukast in Pediatric Allergic Asthma (0476-336)(COMPLETED)
Source: ClinicalTrials.gov NCT00289874 ↗Enrolled (actual)
421
Serious AEs
1.0%
Results posted
Oct 2010
Primary outcomePrimary: Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 3 — 9.53; 9.15 Percent Change
Summary
This is a 3-week study to evaluate FEV1 following treatment with drugs in persistent asthma which is also active during allergy seasons in pediatric patients with seasonal aeroallergen sensitivity.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 3 |
9.53; 9.15 | — |
| SECONDARY Percent Change From Baseline in Mean Daily "as Needed" β-agonist Use Over the 3-week Treatment Period |
-18.88; -12.40 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female patients, ages 6 to 14 years, with persistent asthma that is also active during allergy season
- Patients must demonstrate positive skin prick tests to seasonally relevant geographic aeroallergens
Exclusion Criteria
- Patient cannot have any other acute or chronic pulmonary disorder
Data sourced from ClinicalTrials.gov (NCT00289874). 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. Informational only — not medical advice.