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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00488176

Enrollment

116

Registered

2007-06-20

Start date

2007-04-30

Completion date

2013-12-31

Last updated

2013-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Seasonal Allergic Rhinitis

Keywords

seasonal allergic rhinitis, children, montelukast, cetirizine

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.

Interventions

DRUGmontelukast

montelukast sodium

DRUGcetirizine

cetirizine

DRUGmontelukast and cetirizine

montelukast and cetirizine

DRUGplacebo

placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

6 Years to 18 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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)

Countries

Poland

Contacts

Primary ContactVioletta Ścibiorek, MD

alergol@kopernik.lodz.pl00 48 42 6895972

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026