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The predictive value of the acute effect of montelukast on an exercise challenge test for the outcome of longterm treatment with montelukast.


- candidate number6627
- NTR NumberNTR2059
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-okt-2009
- Secondary IDs 
- Public TitleThe predictive value of the acute effect of montelukast on an exercise challenge test for the outcome of longterm treatment with montelukast.
- Scientific TitleThe predictive value of the acute effect of montelukast on an exercise challenge test for the outcome of longterm treatment with montelukast.
- ACRONYMSD-MLK
- hypothesisWe hypoothesize that the effect that a single dose of montelukast has on exercise induced bronchoconstriction correlates with the effect it has after 8 weeks of treatment.
- Healt Condition(s) or Problem(s) studiedAsthma, Exercise induced bronchoconstriction
- Inclusion criteria1. Age between 12-18 years;
2. Clinical history of allergic asthma and exercise induced bronchoconstriction;
3. Ability to perform reproducible lung function tests, i.e. coefficient of the predicted value variation in 3 of 5 consecutive measurements < 5%;
4. Ability to run on a treadmill for 8 minutes;
5. Maximal FEV1 > 70% of predicted value.
- Exclusion criteria1. Other pulmonary or cardiac illnesses;
2. Maximal FEV1 < 70% of predicted value;
3. Use of systemic corticosteroids, antihistamines, cromoglycates, anticholinergics in two weeks prior to or during the study;
4. Use of long acting bronchodilator agents 24 hours before testing;
5. Use of short acting bronchodilator agents 8 hours before testing;
6. Hospitalization due to asthma exacerbation in past month;
7. Other medication changes during treatment period;
8. Upper or lower respiratory tract infections during treatment period;
9. Deviation of the FEV1 before the subsequent exercise challenges of more than 12 % from baseline FEV1.
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupCrossover
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jan-2010
- planned closingdate10-jan-2010
- Target number of participants19
- Interventions8 weeks of treatment with montelukast.
- Primary outcomeCorrelation between change in postexercise fall in FEV1 after a single dose and after 8 weeks of treatment with montelukast.
- Secondary outcomeThe predictive value for a response to montelukast after 8 weeks of treatment (defined as ΔFEV1 < 15%) of:
1. Baseline FEV1;
2. Symptom score on ACT;
3. IgE;
4. Positive RAST test.
- Timepoints1. t = 0: Baseline visit;
2. t = 1 wk: Start montelukast;
3. t = 1 wk + 2 hr: Second exercise challenge;
4. t = 9 wk: Third exercise challenge.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESdrs. E.T.G. Kersten
- CONTACT for SCIENTIFIC QUERIESdrs. E.T.G. Kersten
- Sponsor/Initiator Medisch Spectrum Twente, Afdeling Kindergeneeskunde
- Funding
(Source(s) of Monetary or Material Support)
Medisch Spectrum Twente
- PublicationsN/A
- Brief summaryIt is a critical clinical question whether a particular therapy will be effective in an individual child with symptoms of asthma. At the moment, there is a lack of diagnostic tools to assess this individual responsiveness. We hypothesize that the effect of a single dose on exercise induced bronchoconstriction could predict the effect of longterm treatment on exercise induced bronchoconstriction.
- Main changes (audit trail)
- RECORD21-okt-2009 - 26-okt-2009


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