Comparison of Combination Therapy: Montelukast and Inhaled Steroid on Exercise Induced Bronchocon… (NCT00462592) | Clinical Trial Compass
CompletedPhase 3
Comparison of Combination Therapy: Montelukast and Inhaled Steroid on Exercise Induced Bronchoconstriction
Canada18 participantsStarted 2007-03
Plain-language 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.
Who can participate
Age range
8 Years – 35 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The magnitude of protection and the number of subjects with ≥50% protection (considered to be clinically relevant) following treatment
Timeframe: Before and after 2 weeks of treatment in each 4 arm