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

Sponsor

Medical University of Lodz (Other)

Overall Status

Unknown status

CT.gov ID

NCT00488176

Collaborator

(none)

116

Enrollment

Location

Arms

Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Seasonal Allergic Rhinitis	Drug: montelukast Drug: cetirizine Drug: montelukast and cetirizine Drug: placebo	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

116 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

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 Start Date :

Apr 1, 2007

Anticipated Primary Completion Date :

Nov 1, 2013

Anticipated Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 monteluksat sodium	Drug: montelukast montelukast sodium Other Names: montelukast sodium
Active Comparator: 2 cetirizine	Drug: cetirizine cetirizine
Active Comparator: 3 montelukast sodium and cetirizine	Drug: montelukast and cetirizine montelukast and cetirizine
Placebo Comparator: 4 placebo	Drug: placebo placebo

Outcome Measures

Primary Outcome Measures

exhaled nitric oxide concentration [baseline (first visit), after 4 weeks (second visit) and after 6 weeks from second visit (third visit)]

Secondary Outcome Measures

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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Pediatrics and Allergy, Medical University of Lodz Lodz, Poland	Lodz		Poland	93-513

Sponsors and Collaborators

Medical University of Lodz

Investigators

Principal Investigator: Violetta Ścibiorek, MD, Department of Pediatrics and Allergy, Medical University of Lodz, Poland
Study Chair: Iwona Stelmach, MD PhD Prof, Department of Pediatrics and Allergy, Medical University of Lodz, Poland