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

February 6, 2013 updated by: Iwona Stelmach, Medical University of Lodz

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

116

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Lodz, Poland, 93-513
        • Recruiting
        • Department of Pediatrics and Allergy, Medical University of Lodz Lodz, Poland
        • Contact:
        • Principal Investigator:
          • Iwona Stelmach, MD, PhD, Prof

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 16 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
baseline (first visit), after 4 weeks (second visit) and after 6 weeks from second visit (third visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Anticipated)

November 1, 2013

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

June 19, 2007

First Submitted That Met QC Criteria

June 19, 2007

First Posted (Estimate)

June 20, 2007

Study Record Updates

Last Update Posted (Estimate)

February 7, 2013

Last Update Submitted That Met QC Criteria

February 6, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RNN/94/07KE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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