Status:
COMPLETED
Montelukast in Modulating Exacerbations of Asthma in Children
Lead Sponsor:
Firestone Institute for Respiratory Health
Conditions:
Asthma
Eligibility:
All Genders
2-14 years
Phase:
PHASE4
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 infection...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
End Date :
November 1 2005
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00196547
Start Date
September 1 2005
End Date
November 1 2005
Last Update
March 16 2012
Active Locations (1)
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1
Firestone Institute for Respiratory Health
Hamilton, Ontario, Canada, L8N 4A6