Phase 3
N=62
Montelukast for Early Life Wheezing
Lung Diseases · Asthma
Bottom Line
View on ClinicalTrials.gov: NCT00115297 ↗Enrolled (actual)
62
Serious AEs
0.0%
Results posted
Feb 2017
Primary outcome: Primary: Number of Wheezing-free Days of Infant (Observed by Primary Caregiver) — 25.5; 30.5 Days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Montelukast (Drug); Placebo (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- University of Massachusetts, Worcester
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Wheezing-free Days of Infant (Observed by Primary Caregiver) |
25.5; 30.5 | — |
| SECONDARY Wheezing at Day 7 |
10; 22 | — |
| SECONDARY The Number of Participants Requiring Rescue Beta Agonist Use |
15; 26 | — |
Summary
This study will determine the effects of montelukast on the duration of wheezing in children 12 months to 3 years of age who visit a physician for care of a wheezing illness. Only patients from the Ankara area of Hacettepe University Medical Center in Turkey will be included in this study.
Eligibility Criteria
Inclusion Criteria
- Physician-diagnosed wheezing illness
Exclusion Criteria
- Asthma
- Prematurity
- Known intolerance to montelukast
Data sourced from ClinicalTrials.gov (NCT00115297). 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.