Montelukast in Modulating Exacerbations of Asthma in Children

This study has been completed.
Sponsor:
Information provided by:
Firestone Institute for Respiratory Health
ClinicalTrials.gov Identifier:
NCT00196547
First received: September 12, 2005
Last updated: March 15, 2012
Last verified: March 2012
  Purpose

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 Intervention Phase
Asthma
Drug: Montelukast (drug)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Randomized Placebo-controlled Trial of Montelukast in Modulating Exacerbations of Asthma in Children, September 2005

Resource links provided by NLM:


Further study details as provided by Firestone Institute for Respiratory Health:

Primary Outcome Measures:
  • Daily asthma symptom score

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

Estimated Enrollment: 200
Study Start Date: September 2005
Estimated Study Completion Date: November 2005
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.

  Eligibility

Ages Eligible for Study:   2 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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 ClinicalTrials.gov identifier: NCT00196547

Locations
Canada, Ontario
Firestone Institute for Respiratory Health
Hamilton, Ontario, Canada, L8N 4A6
Sponsors and Collaborators
Firestone Institute for Respiratory Health
Investigators
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
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00196547     History of Changes
Other Study ID Numbers: R.P. #05-2440
Study First Received: September 12, 2005
Last Updated: March 15, 2012
Health Authority: Canada: Health Canada

Keywords provided by Firestone Institute for Respiratory Health:
Asthma
Respiratory viral infections
Exacerbations
Pediatric
Leukotriene receptor antagonists
School

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Montelukast
Leukotriene Antagonists
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 19, 2014