Comparison of Combination Therapy: Montelukast and Inhaled Steroid on Exercise Induced Bronchoconstriction
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Budesonide | Small molecule | 200 ug | Inhaled |
| Comparator | Montelukast | Other / unclassified | 5 mg | Oral |
| Comparator | Montelukast | Other / unclassified | 10 mg | Oral |