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

Phase 4

• Conditions: Seasonal Allergic Rhinitis
• Interventions: Drug: montelukast; Drug: cetirizine; Drug: montelukast and cetirizine; Drug: placebo

• Registration Number: NCT00488176
• Lead Sponsor: Medical University of Lodz

Brief Summary

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

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.

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-06-19
• Study First Submitted QC: 2007-06-19
• Study First Posted: 2007-06-20
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-06
• Last Update Posted: 2013-02-07
• Primary Completion: 2013-11
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 116

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	montelukast	monteluksat sodium
2	cetirizine	cetirizine
3	montelukast and cetirizine	montelukast sodium and cetirizine
4	placebo	placebo

Primary Outcome Measures

Name	Time	Method
exhaled nitric oxide concentration	baseline (first visit), after 4 weeks (second visit) and after 6 weeks from second visit (third visit)

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Department of Pediatrics and Allergy, Medical University of Lodz Lodz, Poland; 🇵🇱 Lodz, Poland