Montelukast in Modulating Exacerbations of Asthma in Children

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. Identifier: NCT00196547
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : March 16, 2012
Information provided by:
Firestone Institute for Respiratory Health

Brief Summary:
The purpose of the study is to determine if Montelukast added to other therapy, if any, will reduce the severity of asthma symptoms in children during the high incidence of respiratory viral infections that occur in children in the post Labor Day school return period.

Condition or disease Intervention/treatment Phase
Asthma Drug: Montelukast (drug) Phase 4

Detailed Description:
Between 1990- and 2003, we identified in Ontario, and subsequently across Canada, a striking increase in hospital admissions for asthma in children occurring predictably in the third week of September every year.1 In 2000 we undertook a retrospective case-control study comparing the clinical characteristics of children using local emergency rooms for asthma in September, with those of children presenting during the non-epidemic months of July-August. Based on that pilot study of 169 children, we developed a larger prospective case-control study of clinical and biological characteristics of children recruited as they presented to an emergency room for asthma during September 2001. The control group for this study were children recruited from the community who had symptomatic asthma but did not have a September exacerbation requiring emergency room utilization. We identified the presence of rhinovirus in the majority of children attending an ER with acute asthma, and also found rhinovirus in a substantial proportion of the community based controls. We also found a highly significant difference in use of medications for asthma, with the ER cases being much less likely to be receiving adequate anti-inflammatory medication. In September 2004 we conducted a pilot randomized controlled blinded clinical trial of the efficacy of montelukast in reducing morbidity caused by asthma exacerbations associated with respiratory viral infections (RVI) in children aged 2 to 14. We found a highly significant reduction in reported symptom free days in the montelukast group. The current study is a randomized placebo-controlled trial of montelukast, during September 2005 to confirm the results of our pilot study and to examine the effectiveness of montelukast in reducing asthma morbidity during RVIs in different age and sex groups with a range of risk of exacerbations. We also wish to compare the effectiveness of montelukast to placebo in reducing asthma morbidity during RVIs between groups of children concurrently taking no or other classes of asthma control medications.

Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Randomized Placebo-controlled Trial of Montelukast in Modulating Exacerbations of Asthma in Children, September 2005
Study Start Date : September 2005
Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Montelukast

Primary Outcome Measures :
  1. Daily asthma symptom score

Secondary Outcome Measures :
  1. Unscheduled physician visits (including ER)
  2. Oral-cortico-steroid use

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Children aged 2-14 years inclusive
  • Doctor-diagnosed asthma
  • Needing a beta-agonist inhaler at least once weekly on average for symptom relief
  • At least one day lost from school in the past year, or significantly limited activity, because of asthma
  • A history of asthma exacerbations associated with apparent respiratory viral infections
  • Parent or guardian who is willing to provide informed consent
  • Willing to give assent

Exclusion Criteria:

  • Non-English speaking
  • Unable to understand purpose of study and give consent
  • Concomitant respiratory or other major illness e.g. cystic fibrosis, cardiac disease
  • Currently using montelukast or other leukotriene receptor antagonist
  • Using regular oral corticosteroid
  • An asthma exacerbation requiring medical intervention during August 2005

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 identifier (NCT number): NCT00196547

Canada, Ontario
Firestone Institute for Respiratory Health
Hamilton, Ontario, Canada, L8N 4A6
Sponsors and Collaborators
Firestone Institute for Respiratory Health
Principal Investigator: Malcolm R Sears, MB. ChB Firestone Institute for Respiratory Health, St. Joseph's Healthcare, Hamilton
Study Director: Neil W Johnston, MSc Firestone Institute for Respiratory Health, St. Joseph's Healthcare, Hamilton

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00196547     History of Changes
Other Study ID Numbers: R.P. #05-2440
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: March 16, 2012
Last Verified: March 2012

Keywords provided by Firestone Institute for Respiratory Health:
Respiratory viral infections
Leukotriene receptor antagonists

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
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