drugset / Trial / NCT00462592

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

NCT00462592

RandomizedCrossoverDouble-blindTreatment

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.

Timeline

Start
2007-03
Primary completion
2009-06
Completion
2009-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Budesonide Small molecule 200 ug Inhaled
Comparator Montelukast Other / unclassified 5 mg Oral
Comparator Montelukast Other / unclassified 10 mg Oral

Indications