Trial of Montelukast for Treatment of Acute Bronchiolitis
Information source: Medical College of Wisconsin
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bronchiolitis
Intervention: montelukast sodium (Drug); sucrose (Other)
Phase: N/A
Status: Recruiting
Sponsored by: Medical College of Wisconsin Official(s) and/or principal investigator(s):
Marc Gorelick, MD, MSCE, Principal Investigator, Affiliation: Medical College of Wisconsin
Overall contact:
Frank D Petruzella, MD, Phone: 414 337-7180, Email: fpetruze@mcw.edu
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.
Clinical Details
Official title: A Randomized, Double Blind, Placebo Controlled Trial of Daily Montelukast for the Treatment of Viral Bronchiolitis
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Duration of cough
Eligibility
Minimum age: 3 Months.
Maximum age: 12 Months.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male or female infants aged 3 to 12 months of age
- Diagnosis by ED 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
Locations and Contacts
Frank D Petruzella, MD, Phone: 414 337-7180, Email: fpetruze@mcw.edu
Children's Hospital of Wisconsin, Milwaukee, Wisconsin 53226, United States; Recruiting
Frank D Petruzella, MD, Phone: 414-337-7180, Email: fpetruze@mcw.edu
Additional Information
Starting date: December 2008
Ending date: April 2010
Last updated: March 16, 2009
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