N/A
N=141
Trial of Montelukast for Treatment of Acute Bronchiolitis
Bronchiolitis
Bottom Line
View on ClinicalTrials.gov: NCT00863317 ↗Enrolled (actual)
141
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcome: Primary: Duration of Cough — 13; 11 days
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- montelukast sodium (Drug); sucrose (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Medical College of Wisconsin
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Duration of Cough |
13; 11 | — |
Summary
The primary rationale for this study is to evaluate the effect of once daily montelukast on duration of acute illness in infants with first-time bronchiolitis.
Eligibility Criteria
Inclusion Criteria
- Male or female infants aged 3 to 12 months of age
- Diagnosis by emergency physician of bronchiolitis
Exclusion Criteria
- Any previous episode, as determined by a physician, of wheezing, bronchiolitis or asthma
- Any history of previous bronchodilator use prior to this illness
- Treatment with corticosteroids in the 14 days prior to the current illness
- Immunosuppression
- Immunodeficiency
- Caregiver does not speak English
- Diagnosis by the treating ED physician of croup
- Diagnosis by the treating ED physician of pneumonia
- Caregiver does not have access to a telephone
Data sourced from ClinicalTrials.gov (NCT00863317). 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.