Back to resultsTrial of Montelukast for Treatment of Acute Bronchiolitis
Primary Purpose
Bronchiolitis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
montelukast sodium
sucrose
Sponsored by
About this trial
This is an interventional treatment trial for Bronchiolitis focused on measuring Bronchiolitis, montelukast, leukotriene inhibitor
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
Sites / Locations
- Children's Hospital of Wisconsin
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
montelukast sodium
Placebo
Arm Description
4mg granules PO QD for 14 days
Sucrose granules PO QD for 14 days
Outcomes
Primary Outcome Measures
Duration of Cough
Secondary Outcome Measures
Full Information
NCT ID
NCT00863317
First Posted
March 16, 2009
Last Updated
June 19, 2015
Sponsor
Medical College of Wisconsin
1. Study Identification
Unique Protocol Identification Number
NCT00863317
Brief Title
Trial of Montelukast for Treatment of Acute Bronchiolitis
Official Title
A Randomized, Double Blind, Placebo Controlled Trial of Daily Montelukast for the Treatment of Viral Bronchiolitis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis
Keywords
Bronchiolitis, montelukast, leukotriene inhibitor
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
141 (Actual)
8. Arms, Groups, and Interventions
Arm Title
montelukast sodium
Arm Type
Experimental
Arm Description
4mg granules PO QD for 14 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Sucrose granules PO QD for 14 days
Intervention Type
Drug
Intervention Name(s)
montelukast sodium
Other Intervention Name(s)
singulair
Intervention Description
4mg granules daily for 14 days
Intervention Type
Other
Intervention Name(s)
sucrose
Intervention Description
table sugar as placebo daily for 14 days
Primary Outcome Measure Information:
Title
Duration of Cough
Time Frame
up to 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Gorelick, MD, MSCE
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Trial of Montelukast for Treatment of Acute Bronchiolitis
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