Trial of Montelukast for Treatment of Acute Bronchiolitis

This study is currently recruiting participants.

Verified March 2011 by Medical College of Wisconsin

First Received on March 16, 2009. Last Updated on March 3, 2011 History of Changes

Sponsor:	Medical College of Wisconsin
Collaborators:	Children's Research Institue Medical College of Wisconsin Quantitative Health Sciences
Information provided by:	Medical College of Wisconsin
ClinicalTrials.gov Identifier:	NCT00863317

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:

Drug Information available for: Sucrose Montelukast sodium Montelukast

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 ]

Estimated Enrollment:	198
Study Start Date:	December 2008
Estimated Study Completion Date:	July 2011
Estimated 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

Contacts

Contact: Duke Wagner

414-337-2623

dwagner@mcw.edu

Locations

United States, Wisconsin
Children's Hospital of Wisconsin	Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Duke Wagner 414-337-2623 dwagner@mcw.edu

Sponsors and Collaborators

Medical College of Wisconsin

Children's Research Institue

Medical College of Wisconsin Quantitative Health Sciences

Investigators

Principal Investigator:

Marc Gorelick, MD, MSCE

Medical College of Wisconsin

More Information

No publications provided

Responsible Party:	Marc Gorelick, MD, MSCE/Section Chief, Pediatric Emegency Medicine, Medical College of Wisconsin/Children's Research Institiute
ClinicalTrials.gov Identifier:	NCT00863317 History of Changes
Other Study ID Numbers:	FDP-01, IND 103263
Study First Received:	March 16, 2009
Last Updated:	March 3, 2011
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 February 09, 2012