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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-016904-21-NL

Enrollment

Registered

2009-12-16

Start date

2010-04-22

Completion date

Unknown

Last updated

2013-07-15

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

Conditions

Exercise induced asthma / bronchoconstriction Asthma MedDRA version: 12.0 Level: LLT Classification code 10015649 Term: Exercise induced asthma MedDRA version: 12.0 Level: LLT Classification code 10066091 Term: Bronchial hyperreactivity MedDRA version: 12.0 Level: PT Classification code 10003553 Term: Asthma

Interventions

Trade Name: Singulair (montelukast sodium) Pharmaceutical Form: Tablet INN or Proposed INN: MONTELUKAST SODIUM CAS Number: 151767-02-1 Concentration unit: mg milligram(s) Concentration type: equal Con

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 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 70% of predicted value Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - 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 medication changes 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

Design outcomes

Primary

Measure	Time frame
Primary end point(s): Correlation between change in postexercise fall in FEV1 2h after a single dose of montelukast and after 8 weeks of treatment with montelukast. ;Main Objective: What is the correlation between change in % fall in FEV1 (?FEV1) after an exercise challenge 2h after a single dose of montelukast and after 8 weeks of treatment with montelukast?;Secondary Objective: Which individual patient and disease characteristics correlate with an effect of montelukast on EIB?	—

Measure

Time frame

Primary end point(s): Correlation between change in postexercise fall in FEV1 2h after a single dose of montelukast and after 8 weeks of treatment with montelukast. ;Main Objective: What is the correlation between change in % fall in FEV1 (?FEV1) after an exercise challenge 2h after a single dose of montelukast and after 8 weeks of treatment with montelukast?;Secondary Objective: Which individual patient and disease characteristics correlate with an effect of montelukast on EIB?

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Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026