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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.

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON23949
Enrollment
19
Registered
2009-10-21
Start date
2010-01-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

asthma exercise induced bronchoconstriction leukotriene receptor antagonist

Interventions

8 weeks of treatment with montelukast.

Sponsors

dr. B.J. Thio 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
Lead Sponsor

Eligibility

Inclusion criteria

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 70% of predicted value.

Exclusion criteria

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 outcomes

Primary

MeasureTime frame
Correlation between change in postexercise fall in FEV1 after a single dose and after 8 weeks of treatment with montelukast.

Secondary

MeasureTime frame
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.

Contacts

Public ContactE.T.G. Kersten

Postbus 50.000

E.Kersten@ziekenhuis-mst.nl+31 (0)53 4872310

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)