Exercise induced bronchoconstriction in children – a single dose of montelukast as alternative to regular daily doses.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-003652-39-DK

Enrollment

Registered

2012-07-31

Start date

2012-09-17

Completion date

Unknown

Last updated

2020-06-22

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

Conditions

Exercise induced asthma MedDRA version: 18.1 Level: LLT Classification code 10015649 Term: Exercise induced asthma System Organ Class: 100000004855

Interventions

Trade Name: Singulair Pharmaceutical Form: Capsule, hard INN or Proposed INN: Montelukast Other descriptive name: MONTELUKAST SODIUM Concentration unit: mg milligram(s) Concentration type: equal Conce

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Written informed consent from child and parent or guardian. Age 10 - 14 years. Proven exercise-induced asthma with a decrease in FEV1 of >12%. Background medicine: inhaled corticosteroid therapy (equivalent to max 400-800mikg budesonide daily or equipotent doses). FEV1 baseline = 85% of predicted normal value. Participants must be able to swallow a medicine capsule. Are the trial subjects under 18? yes Number of subjects for this age range: 32 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: Inability to use the study equipment correctly. Treatment with long acting beta2-agonists. Changing the background medication during the study period. Short-acting beta2-agonists must not be used within 8 hours before the running test. Antihistamines must not be used within 72 hours before the running test. Hereditary galactose intolerance. If the child is receiving regular montelukast, this treatment must be stopped within two weeks before the commencement of the trial. Temperature above 38.5 or infection-related respiratory symptoms on days with scheduled running test.

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the effect of a single dose of montelukast and regular daily use of montelukast in children with exercise induced bronchoconstriction. ;Secondary Objective: To evaluate the onset and duration of protection against exercise induced bronchoconstriction after a single dose of montelukast.;Primary end point(s): To assess bronchoconstriction after the exercise challenge. The maximum percentage decrease in FEV1 after exercise challenge. ;Timepoint(s) of evaluation of this end point: The maximal postexercise fall in FEV1 is evaluated 2, 5, 8 and 11 hours after the last dose of montelukast/placebo.	—

Measure

Time frame

Main Objective: To compare the effect of a single dose of montelukast and regular daily use of montelukast in children with exercise induced bronchoconstriction. ;Secondary Objective: To evaluate the onset and duration of protection against exercise induced bronchoconstriction after a single dose of montelukast.;Primary end point(s): To assess bronchoconstriction after the exercise challenge. The maximum percentage decrease in FEV1 after exercise challenge. ;Timepoint(s) of evaluation of this end point: The maximal postexercise fall in FEV1 is evaluated 2, 5, 8 and 11 hours after the last dose of montelukast/placebo.

—

Secondary

Measure	Time frame
Secondary end point(s): To assess bronchoconstriction after the exercise challenge, the maximal percentage fall in FEV1 is measured. Need for ß-agonist rescue. ;Timepoint(s) of evaluation of this end point: The maximal postexercise fall in FEV1 is evaluated 2, 5, 8 and 11 hours after the last dose of montelukast/placebo. Need for ß-agonist rescue up to 90 minutes after exercise challenge test.	—

Countries

Denmark

Contacts

Public ContactKaren Schow Jensen

Karen Schow Jensen

KASCJE@rm.dk

Outcome results

None listed

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