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NCT00488176 Clinical Trial

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

Seasonal Allergic Rhinitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00488176
Other study ID # RNN/94/07KE
Secondary ID
Status Recruiting
Phase Phase 4
First received June 19, 2007
Last updated February 6, 2013
Start date April 2007
Est. completion date December 2013

Study information
Verified date February 2013
Source Medical Universtity of Lodz
Contact Violetta Scibiorek, MD
Phone 00 48 42 6895972
Email alergol@kopernik.lodz.pl
Is FDA regulated No
Health authority Poland: Ministry of Health
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 116
Est. completion date December 2013
Est. primary completion date November 2013
Accepts healthy volunteers No
Gender Both
Age group 6 Years to 18 Years
Eligibility 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

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

Related Conditions & MeSH terms

Intervention

Drug:
• montelukast
montelukast sodium
• cetirizine
cetirizine
• montelukast and cetirizine
montelukast and cetirizine
• placebo
placebo

Locations
Country Name City State
Poland Department of Pediatrics and Allergy, Medical University of Lodz Lodz, Poland Lodz

Sponsors (1)
Lead Sponsor Collaborator
Medical Universtity of Lodz

Country where clinical trial is conducted

Poland, 

Outcome
Type Measure Description Time frame Safety issue
Primary exhaled nitric oxide concentration baseline (first visit), after 4 weeks (second visit) and after 6 weeks from second visit (third visit) No
Secondary 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) No
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