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Trial of Montelukast for Treatment of Acute Bronchiolitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00863317
First Posted: March 18, 2009
Last Update Posted: July 15, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Frank Petruzella, Medical College of Wisconsin
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 Frank Petruzella, Medical College of Wisconsin:

Primary Outcome Measures:
  • Duration of Cough [ Time Frame: up to 4 weeks ]

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 ( Other Identifier: FDA )
First Submitted: March 16, 2009
First Posted: March 18, 2009
Results First Submitted: June 2, 2015
Results First Posted: June 19, 2015
Last Update Posted: July 15, 2015
Last Verified: June 2015

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

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Montelukast
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action