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

NCT ID: NCT00488176

Last Updated: 2013-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2013-12-31

Brief Summary

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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

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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.

Conditions

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Seasonal Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

monteluksat sodium

Group Type ACTIVE_COMPARATOR

montelukast

Intervention Type DRUG

montelukast sodium

2

cetirizine

Group Type ACTIVE_COMPARATOR

cetirizine

Intervention Type DRUG

cetirizine

3

montelukast sodium and cetirizine

Group Type ACTIVE_COMPARATOR

montelukast and cetirizine

Intervention Type DRUG

montelukast and cetirizine

4

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo

Interventions

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montelukast

montelukast sodium

Intervention Type DRUG

cetirizine

cetirizine

Intervention Type DRUG

montelukast and cetirizine

montelukast and cetirizine

Intervention Type DRUG

placebo

placebo

Intervention Type DRUG

Other Intervention Names

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montelukast sodium

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Lodz

OTHER

Sponsor Role lead

Responsible Party

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Iwona Stelmach

MD, PhD, Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Violetta Ścibiorek, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Pediatrics and Allergy, Medical University of Lodz, Poland

Iwona Stelmach, MD PhD Prof

Role: STUDY_CHAIR

Department of Pediatrics and Allergy, Medical University of Lodz, Poland

Locations

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Department of Pediatrics and Allergy, Medical University of Lodz Lodz, Poland

Lodz, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Violetta Ścibiorek, MD

Role: CONTACT

00 48 42 6895972

Facility Contacts

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Violetta Ścibiorek, MD

Role: primary

00 48 42 689 59 72

Other Identifiers

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RNN/94/07KE

Identifier Type: -

Identifier Source: org_study_id

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