Overview

Comparison of Combination Therapy: Montelukast and Inhaled Steroid on Exercise Induced Bronchoconstriction

Status:
Completed
Trial end date:
2009-06-01
Target enrollment:
0
Participant gender:
All
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 and young adults, not on regular controller therapy. Inhaled corticosteroids (ICS) are potent anti-inflammatory agents, which are effective in controlling and improving all aspects of asthma including the attenuation of EIB. However, the effect of ICS monotherapy on EIB is comparable if not inferior to the effect of CysLTs modifiers alone. This may be due to the lack of effect of ICS on the CysLT pathway. As a consequence, the investigators hypothesize that the combination of ICS and CysLT modifiers will offer a greater protection against EIB than either therapy alone. The different classes of drugs may act on complementary pathways believed to be important in the pathophysiology of EIB.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hamilton Health Sciences Corporation
Collaborator:
Merck Sharp & Dohme Corp.
Treatments:
Budesonide
Montelukast
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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.