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

Phase 1

• Conditions: MedDRA version: 18.1Level: LLTClassification code 10015649Term: Exercise induced asthmaSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]; Exercise induced asthma

• Registration Number: EUCTR2011-003652-39-DK
• Lead Sponsor: Karen Schow Jensen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-07-31
• Last Update Posted: 22 June 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 32

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified