No registrations found.
ID
Source
Brief title
Health condition
asthma
exercise induced bronchoconstriction
leukotriene receptor antagonist
Sponsors and support
Medisch Spectrum Twente
Afdeling kindergeneeskunde
Haaksbergerstraat 55, 7513 ER Enschede
Postadres: Postbus 50.000, 7500 KA Enschede
Tel: (053)-4872310
Email: B.Thio@ziekenhuis-mst.nl
Intervention
Outcome measures
Primary outcome
Correlation between change in postexercise fall in FEV1 after a single dose and after 8 weeks of treatment with montelukast.
Secondary outcome
The 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.
Background summary
It 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.
Study objective
We 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.
Study design
1. 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.
Intervention
8 weeks of treatment with montelukast.
E.T.G. Kersten
Enschede 7513 ER
The Netherlands
+31 (0)53 4872310
E.Kersten@ziekenhuis-mst.nl
E.T.G. Kersten
Enschede 7513 ER
The Netherlands
+31 (0)53 4872310
E.Kersten@ziekenhuis-mst.nl
Inclusion criteria
1. 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 criteria
1. 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1942 |
| NTR-old | NTR2059 |
| Other | : |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |