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

This study is currently recruiting participants.

Verified February 2013 by Medical Universtity of Lodz

Sponsor:

Information provided by (Responsible Party):

Iwona Stelmach, Medical Universtity of Lodz

ClinicalTrials.gov Identifier:

NCT00488176

First received: June 19, 2007

Last updated: February 6, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

June 19, 2007

Last Updated Date

February 6, 2013

Start Date ^ICMJE

April 2007

Estimated Primary Completion Date

November 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

exhaled nitric oxide concentration [ Time Frame: baseline (first visit), after 4 weeks (second visit) and after 6 weeks from second visit (third visit) ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00488176 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

symptoms score (based on PAQLQ), bronchial hyperresponsiveness with methacholine, spirometry, PEFR measurements [ Time Frame: baseline (first visit), after 4 weeks (second visit) and after 6 weeks from second visit (third visit) ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Seasonal Allergic Rhinitis

Intervention ^ICMJE

Drug: montelukast
montelukast sodium

Other Name: montelukast sodium
Drug: cetirizine
cetirizine

Other Name: cetirizine
Drug: montelukast and cetirizine
montelukast and cetirizine

Other Name: montelukast and cetirizine
Drug: placebo
placebo

Other Name: placebo

Study Arm (s)

Active Comparator: 1
monteluksat sodium

Intervention: Drug: montelukast
Active Comparator: 2
cetirizine

Intervention: Drug: cetirizine
Active Comparator: 3
montelukast sodium and cetirizine

Intervention: Drug: montelukast and cetirizine
Placebo Comparator: 4
placebo

Intervention: Drug: placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

116

Estimated Completion Date

December 2013

Estimated Primary Completion Date

November 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

6 Years to 18 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Violetta Ścibiorek, MD

00 48 42 6895972

alergol@kopernik.lodz.pl

Location Countries ^ICMJE

Poland

Administrative Information

NCT Number ^ICMJE

NCT00488176

Other Study ID Numbers ^ICMJE

RNN/94/07KE

Has Data Monitoring Committee

Yes

Responsible Party

Iwona Stelmach, Medical Universtity of Lodz

Study Sponsor ^ICMJE

Medical Universtity of Lodz

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Medical Universtity of Lodz

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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