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Trial of Montelukast for Treatment of Acute Bronchiolitis

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ClinicalTrials.gov Identifier: NCT00863317
Recruitment Status : Completed
First Posted : March 18, 2009
Results First Posted : June 19, 2015
Last Update Posted : July 15, 2015
Sponsor:
Information provided by (Responsible Party):
Frank Petruzella, Medical College of Wisconsin

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Bronchiolitis Drug: montelukast sodium Other: sucrose Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 141 participants
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
Study Start Date : December 2008
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


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

Eligibility Criteria
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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
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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
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United States, Wisconsin
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
Investigators
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Principal Investigator: Marc Gorelick, MD, MSCE Medical College of Wisconsin
More Information
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Responsible Party: Frank Petruzella, Pediatric Emergency Physician, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT00863317    
Other Study ID Numbers: FDP-01
IND 103263 ( Other Identifier: FDA )
First Posted: March 18, 2009    Key Record Dates
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:
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Bronchiolitis
Bronchitis
Respiratory Tract Infections
Infections
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
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