Trial of Montelukast for Treatment of Acute Bronchiolitis
A Randomized, Double Blind, Placebo Controlled Trial of Daily Montelukast for the Treatment of Viral Bronchiolitis
2 other identifiers
interventional
141
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2008
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 16, 2009
CompletedFirst Posted
Study publicly available on registry
March 18, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedResults Posted
Study results publicly available
June 19, 2015
CompletedJuly 15, 2015
June 1, 2015
2.6 years
March 16, 2009
June 2, 2015
June 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Duration of Cough
up to 4 weeks
Study Arms (2)
montelukast sodium
EXPERIMENTAL4mg granules PO QD for 14 days
Placebo
PLACEBO COMPARATORSucrose granules PO QD for 14 days
Interventions
Eligibility Criteria
You may qualify if:
- Male or female infants aged 3 to 12 months of age
- Diagnosis by emergency physician of bronchiolitis
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Frank Petruzella
- Organization
- Richmond Emergency Physicians Inc
Study Officials
- PRINCIPAL INVESTIGATOR
Marc Gorelick, MD, MSCE
Medical College of Wisconsin
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Pediatric Emergency Physician
Study Record Dates
First Submitted
March 16, 2009
First Posted
March 18, 2009
Study Start
December 1, 2008
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
July 15, 2015
Results First Posted
June 19, 2015
Record last verified: 2015-06