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NCT00863317 Clinical Trial

Trial of Montelukast for Treatment of Acute Bronchiolitis

Bronchiolitis Clinical Trial

Official title:
A Randomized, Double Blind, Placebo Controlled Trial of Daily Montelukast for the Treatment of Viral Bronchiolitis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00863317
Other study ID # FDP-01
Secondary ID IND 103263
Status Completed
Phase N/A
First received March 16, 2009
Last updated June 19, 2015
Start date December 2008
Est. completion date July 2011

Study information
Verified date June 2015
Source Medical College of Wisconsin
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 141
Est. completion date July 2011
Est. primary completion date July 2011
Accepts healthy volunteers No
Gender Both
Age group 3 Months to 12 Months
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• montelukast sodium
4mg granules daily for 14 days
Other:
• sucrose
table sugar as placebo daily for 14 days

Locations
Country Name City State
United States Children's Hospital of Wisconsin Milwaukee Wisconsin

Sponsors (1)
Lead Sponsor Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Duration of Cough up to 4 weeks No
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