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

Overview[ - collapse ][ - ]

Purpose 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.
ConditionSeasonal Allergic Rhinitis
InterventionDrug: montelukast
Drug: cetirizine
Drug: montelukast and cetirizine
Drug: placebo
PhasePhase 4
SponsorMedical Universtity of Lodz
Responsible PartyMedical Universtity of Lodz
ClinicalTrials.gov IdentifierNCT00488176
First ReceivedJune 19, 2007
Last UpdatedFebruary 6, 2013
Last verifiedFebruary 2013

Tracking Information[ + expand ][ + ]

First Received DateJune 19, 2007
Last Updated DateFebruary 6, 2013
Start DateApril 2007
Estimated Primary Completion DateDecember 2013
Current Primary Outcome Measuresexhaled 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]
Current Secondary Outcome Measuressymptoms 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]

Descriptive Information[ + expand ][ + ]

Brief TitleComparison of the Effect of Montelukast and Cetirizine on Allergic Inflammation in Children With Allergic Rhinitis
Official TitleComparison 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 TypeInterventional
Study PhasePhase 4
Study DesignAllocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
ConditionSeasonal Allergic Rhinitis
InterventionDrug: montelukast
montelukast sodium
Other Names:
montelukast sodiumDrug: cetirizine
cetirizine
Other Names:
cetirizineDrug: montelukast and cetirizine
montelukast and cetirizine
Other Names:
montelukast and cetirizineDrug: placebo
placebo
Other Names:
placebo
Study Arm (s)
  • Active Comparator: 1
    monteluksat sodium
  • Active Comparator: 2
    cetirizine
  • Active Comparator: 3
    montelukast sodium and cetirizine
  • Placebo Comparator: 4
    placebo

Recruitment Information[ + expand ][ + ]

Recruitment StatusRecruiting
Estimated Enrollment116
Estimated Completion DateDecember 2013
Estimated Primary Completion DateNovember 2013
Eligibility Criteria
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
GenderBoth
Ages6 Years
Accepts Healthy VolunteersNo
ContactsContact: Violetta Ścibiorek, MD
00 48 42 6895972
alergol@kopernik.lodz.pl
Location CountriesPoland

Administrative Information[ + expand ][ + ]

NCT Number NCT00488176
Other Study ID NumbersRNN/94/07KE
Has Data Monitoring CommitteeYes
Information Provided ByMedical Universtity of Lodz
Study SponsorMedical Universtity of Lodz
CollaboratorsNot Provided
Investigators Principal Investigator: Violetta Ścibiorek, MD Department of Pediatrics and Allergy, Medical University of Lodz, PolandStudy Chair: Iwona Stelmach, MD PhD Prof Department of Pediatrics and Allergy, Medical University of Lodz, Poland
Verification DateFebruary 2013

Locations[ + expand ][ + ]

Department of Pediatrics and Allergy, Medical University of Lodz Lodz, Poland
Lodz, Poland, 93-513
Contact: Violetta Ścibiorek, MD | 00 48 42 689 59 72 | alergol@kopernik.lodz.pl
Principal Investigator: Iwona Stelmach, MD, PhD, Prof
Recruiting