EUCTR2011-003652-39-DK
Active, not recruiting
Phase 1
Exercise induced bronchoconstriction in children – a single dose of montelukast as alternative to regular daily doses.
Karen Schow Jensen0 sites32 target enrollmentJuly 31, 2012
ConditionsExercise induced asthmaMedDRA version: 18.1Level: LLTClassification code 10015649Term: Exercise induced asthmaSystem Organ Class: 100000004855Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
DrugsSingulair
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Exercise induced asthma
- Sponsor
- Karen Schow Jensen
- Enrollment
- 32
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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.
Outcomes
Primary Outcomes
Not specified
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