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

Information source: Medical Universtity of Lodz
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Seasonal Allergic Rhinitis

Intervention: montelukast (Drug); cetirizine (Drug); montelukast and cetirizine (Drug); placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Medical Universtity of Lodz

Official(s) and/or principal investigator(s):
Violetta Ścibiorek, MD, Principal Investigator, Affiliation: Department of Pediatrics and Allergy, Medical University of Lodz, Poland
Iwona Stelmach, MD PhD Prof, Study Chair, Affiliation: Department of Pediatrics and Allergy, Medical University of Lodz, Poland

Overall contact:
Violetta Ścibiorek, MD, Phone: 00 48 42 6895972, Email: alergol@kopernik.lodz.pl

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: exhaled nitric oxide concentration

Secondary outcome: symptoms score (based on PAQLQ), bronchial hyperresponsiveness with methacholine, spirometry, PEFR measurements

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.

Eligibility

Minimum age: 6 Years. Maximum age: 18 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Violetta Ścibiorek, MD, Phone: 00 48 42 6895972, Email: alergol@kopernik.lodz.pl

Department of Pediatrics and Allergy, Medical University of Lodz Lodz, Poland, Lodz 93-513, Poland; Recruiting
Violetta Ścibiorek, MD, Phone: 00 48 42 689 59 72, Email: alergol@kopernik.lodz.pl
Iwona Stelmach, MD, PhD, Prof, Principal Investigator
Additional Information

Starting date: April 2007
Last updated: February 6, 2013

Page last updated: August 23, 2015

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