Comparison of the Effect of Montelukast and Cetirizine on Allergic Inflammation in Children With Allergic Rhinitis

Study Overview
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Brief Summary
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The aim of this study is to compare the effect of montelukast and cetirizine on allergic inflammation measured by exhaled nitric oxide concentration in children with seasonal allergic rhinitis.

Detailed Description
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During the pollen season children with seasonal allergic rhinitis without concomitant asthma are at risk of having allergic inflammation in the lower respiratory tract. About 60% of children with seasonal allergic rhinitis present bronchial hyperresponsiveness and signs and symptoms of asthma. The aim of this study is to compare the effect of montelukast and cetirizine on allergic inflammation measured by exhaled nitric oxide concentration in children with seasonal allergic rhinitis.

Official Title
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Comparison of the Effect of Montelukast and Cetirizine on Allergic Inflammation Measured by Exhaled Nitric Oxide Concentration in Children With Seasonal Allergic Rhinitis

Conditions
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Seasonal Allergic Rhinitis

Intervention / Treatment
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* Drug: montelukast
* Drug: cetirizine
* Drug: montelukast and cetirizine
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinical symptoms of seasonal allergic rhinitis during last two seasons, moderate and severe according to ARIA guidelines Exclusion Criteria: diagnosis of bronchial asthma allergy to perennial allergens specific immunotherapy other chronic diseases tobacco smoking acute respiratory tract infection excluded drugs: inhaled and systemic glucocorticosteroids

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>monteluksat sodium | Drug: montelukast<br>* montelukast sodium<br>* Other names: montelukast sodium;|
| Active Comparator: 2<br>cetirizine | Drug: cetirizine<br>* cetirizine<br>|
| Active Comparator: 3<br>montelukast sodium and cetirizine | Drug: montelukast and cetirizine<br>* montelukast and cetirizine<br>|
| Placebo Comparator: 4<br>placebo | Drug: placebo<br>* placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| exhaled nitric oxide concentration |  | baseline (first visit), after 4 weeks (second visit) and after 6 weeks from second visit (third visit) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| symptoms score (based on PAQLQ), bronchial hyperresponsiveness with methacholine, spirometry, PEFR measurements |  | baseline (first visit), after 4 weeks (second visit) and after 6 weeks from second visit (third visit) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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seasonal allergic rhinitis, children, montelukast, cetirizine