Status:
COMPLETED
Comparison of Combination Therapy: Montelukast and Inhaled Steroid on Exercise Induced Bronchoconstriction
Lead Sponsor:
Hamilton Health Sciences Corporation
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Asthma
Eligibility:
All Genders
8-35 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the effects of 2 weeks therapy of montelukast, budesonide, their combination on exercise induced bronchoconstriction (EIB) and airway inflammation in children a...
Detailed Description
The study will be a 2 centre randomised, double blind, placebo controlled 4-way cross over study comparing montelukast, budesonide and their combination on exercise-induced bronchoconstriction (EIB). ...
Eligibility Criteria
Inclusion
- Males or females ages 8-35 years with stable mild-to-moderate asthma (ATS criteria) not on regular controller therapy
- Prebronchodilator FEV1 predicted ≥ 70%
- No other medical co-morbidity
- Demonstrate maxFEV1% ≥15% on exercise challenge at screening and 1 week post run-in.
Exclusion
- Asthma exacerbations or respiratory infection within 4 weeks of screening
- Recent use of inhaled or systemic steroids
- Immunosuppressives
- Antihistamines, NSAIDs and investigational drugs within 30 days
- Unable to reliably perform spirometry and exercise challenge
- Current or ex-smokers ≥ 10 pack-years and less than 1 month abstinence
- Contra-indications to inhaled steroids or montelukast use.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00462592
Start Date
March 1 2007
End Date
June 1 2009
Last Update
October 21 2009
Active Locations (2)
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1
Hamilton Health Sciences-McMaster University
Hamilton, Ontario, Canada, L8N 3Z5
2
Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8