Trial of Montelukast for Treatment of Acute Bronchiolitis
NCT ID: NCT00863317
Last Updated: 2015-07-15
Study Results
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View full resultsBasic Information
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COMPLETED
NA
141 participants
INTERVENTIONAL
2008-12-31
2011-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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montelukast sodium
4mg granules PO QD for 14 days
montelukast sodium
4mg granules daily for 14 days
Placebo
Sucrose granules PO QD for 14 days
sucrose
table sugar as placebo daily for 14 days
Interventions
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montelukast sodium
4mg granules daily for 14 days
sucrose
table sugar as placebo daily for 14 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis by emergency physician of bronchiolitis
Exclusion Criteria
* 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
3 Months
12 Months
ALL
No
Sponsors
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Medical College of Wisconsin
OTHER
Responsible Party
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Frank Petruzella
Pediatric Emergency Physician
Principal Investigators
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Marc Gorelick, MD, MSCE
Role: PRINCIPAL_INVESTIGATOR
Medical College of Wisconsin
Locations
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Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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IND 103263
Identifier Type: OTHER
Identifier Source: secondary_id
FDP-01
Identifier Type: -
Identifier Source: org_study_id
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