Phase 3
Completed N=62
Montelukast for Early Life Wheezing
Source: ClinicalTrials.gov NCT00115297 ↗Enrolled (actual)
62
Serious AEs
0.0%
Results posted
Feb 2017
Primary outcomePrimary: Number of Wheezing-free Days of Infant (Observed by Primary Caregiver) — 25.5; 30.5 Days
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 | — |
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. Informational only — not medical advice.