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Trial of Montelukast for Treatment of Acute Bronchiolitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Frank Petruzella, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT00863317
First received: March 16, 2009
Last updated: September 18, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention
Bronchiolitis
 Drug: montelukast sodium
Other: sucrose

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Placebo Controlled Trial of Daily Montelukast for the Treatment of Viral Bronchiolitis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:
  • Duration of cough [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 124
Study Start Date: December 2008
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Montelukast
4mg granules
 Drug: montelukast sodium
4mg granules daily for 14 days
Other Name: singulair
Placebo Comparator: sucrose Other: sucrose
table sugar as placebo daily for 14 days

  Eligibility

Ages Eligible for Study:   3 Months to 12 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00863317

Locations
United States, Wisconsin
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
Investigators
Principal Investigator: Marc Gorelick, MD, MSCE Medical College of Wisconsin
  More Information

No publications provided

Responsible Party: Frank Petruzella, Pediatric Emergency Physician, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT00863317     History of Changes
Other Study ID Numbers: FDP-01, IND 103263
Study First Received: March 16, 2009
Last Updated: September 18, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Medical College of Wisconsin:
Bronchiolitis
montelukast
leukotriene inhibitor

Additional relevant MeSH terms:
Bronchiolitis
Bronchiolitis, Viral
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Virus Diseases
 Montelukast
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013