Time-Effect of Montelukast Protection

Study Overview
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Brief Summary
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The aim of this study is to verify MNT time of onset of protection against EIB in asthmatic children by evaluating different time intervals between dosing and challenge, after a single-dose and after three days of once a day MNT administration.

Detailed Description
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Within few days after a baseline exercise challenge, children was randomized to a double blind, placebo-controlled, three day doses, crossover study design. In practice each eligible patient was randomized by a computer-generated schedule to receive in sequence double-blind treatments with placebo or MNT (5 mg). Patients in sequence 1 received MNT, then crossed over to matching placebo; vice versa the case was for patients in sequence 2. Placebo and active treatments were separated by a 7-10 day wash-out period. Each child was assigned to one out of seven groups in order to perform the exercise challenge at different time intervals from drug administration which occurred always at 8.00 A.M. On day one the challenge was performed in the different groups 1, 2, 3, 4, 5, 6, and 8 hours after drug administration, respectively. Then treatment was continued as a single day dose for three consecutive days and a third challenge was then performed at the same time of the day.

Official Title
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Time-Effect of Montelukast on Protection Against Exercise-Induced Bronchoconstriction

Conditions
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Exercise-Induced Asthma, Asthma

Intervention / Treatment
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* Drug: Montelukast
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children with exercise-induced asthma Exclusion Criteria: viral infections montelukast treatment

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Montelukast<br>capsules prepared in blindness | Drug: Montelukast<br>* Montelukast 5 mg<br>* Other names: Singulair;|
| Placebo Comparator: Placebo<br>matched placebo | Drug: Placebo<br>* capsules of matching placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maximal percentage fall in FEV1 after exercise test from the baseline value |  | at the first and at the third day of single day drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical protection |  | at the first and at the third day of single day drug administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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asthma, exercise-induced bronchoconstriction, montelukast, clinical protection, children, time effect