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Trial of Montelukast for Treatment of Acute Bronchiolitis

Not Applicable
Completed
Conditions
Bronchiolitis
Interventions
Registration Number
NCT00863317
Lead Sponsor
Medical College of Wisconsin
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
141
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PlacebosucroseSucrose granules PO QD for 14 days
montelukast sodiummontelukast sodium4mg granules PO QD for 14 days
Primary Outcome Measures
NameTimeMethod
Duration of Coughup to 4 weeks
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Children's Hospital of Wisconsin

🇺🇸

Milwaukee, Wisconsin, United States

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