The predictive value of the acute effect of montelukast on an exercise challenge test for the outcome of longterm treatment with montelukast
- Conditions
- exercise induced bronchoconstriction10006436
- Registration Number
- NL-OMON34924
- Lead Sponsor
- Medisch Spectrum Twente
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 19
- Age between 12-18 years
- Clinical history of allergic asthma and exercise induced bronchoconstriction
- Ability to perform reproducible lung function tests, i.e. coefficient of the predicted value variation in 3 of 5 consecutive measurements < 5%
- Ability to run on a treadmill for 8 minutes
- Maximal FEV1 > 70% of predicted value
- Other pulmonary or cardiac illnesses
- Maximal FEV1 < 70% of predicted value
- Use of systemic corticosteroids, antihistamines, cromoglycates, anticholinergics in two weeks prior to or during the study
- Use of long acting bronchodilator agents 24 hours before testing
- Use of short acting bronchodilator agents 8 hours before testing
- Hospitalization due to asthma exacerbation in past month
- Other changes in asthma medication during treatment period
- Upper or lower respiratory tract infections during treatment period
- Deviation of the FEV1 before the subsequent exercise challenges of more than 12 % from baseline FEV1
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Correlation between change in ΔFEV1 after a single dose of montelukast and<br /><br>after 4 weeks of treatment with montelukast. </p><br>
- Secondary Outcome Measures
Name Time Method <p>The predictive value for a response to montelukast after 4 weeks of treatment<br /><br>(defined as ΔFEV1 < 15%) of:<br /><br>- baseline FEV1<br /><br>- symptom score on ACT<br /><br>- IgE<br /><br>- positive RAST test</p><br>