Trial of Montelukast for Treatment of Acute Bronchiolitis

This study has been completed.
Information provided by (Responsible Party):
Frank Petruzella, Medical College of Wisconsin Identifier:
First received: March 16, 2009
Last updated: June 19, 2015
Last verified: June 2015
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
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:

Further study details as provided by Medical College of Wisconsin:

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

Enrollment: 141
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 sodium
4mg granules PO QD for 14 days
Drug: montelukast sodium
4mg granules daily for 14 days
Other Name: singulair
Placebo Comparator: Placebo
Sucrose granules PO QD for 14 days
Other: sucrose
table sugar as placebo daily for 14 days


Ages Eligible for Study:   3 Months to 12 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00863317

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

Responsible Party: Frank Petruzella, Pediatric Emergency Physician, Medical College of Wisconsin Identifier: NCT00863317     History of Changes
Other Study ID Numbers: FDP-01  IND 103263 
Study First Received: March 16, 2009
Results First Received: June 2, 2015
Last Updated: June 19, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Medical College of Wisconsin:
leukotriene inhibitor

Additional relevant MeSH terms:
Bronchial Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Tract Diseases
Respiratory Tract Infections
Anti-Asthmatic Agents
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Leukotriene Antagonists
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Respiratory System Agents processed this record on May 23, 2016