Montelukast in Modulating Exacerbations of Asthma in Children

• Status: Completed
• Trial end date: 2005-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Firestone Institute for Respiratory Health
• Treatments: Montelukast

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