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

Seasonal Allergic Rhinitis research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Seasonal Allergic Rhinitis

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:montelukastmontelukast sodium

Drug:cetirizinecetirizine

Drug:montelukast and cetirizinemontelukast and cetirizine

Drug:placeboplacebo

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

1monteluksat sodium

2cetirizine

3montelukast sodium and cetirizine

4placebo

Study Status

Unknown status

Start Date: April 2007

Completed Date: December 2013

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: exhaled nitric oxide concentration

Secondary Outcome: symptoms score (based on PAQLQ), bronchial hyperresponsiveness with methacholine, spirometry, PEFR measurements

Study sponsors, principal investigator, and references

Principal Investigator: Violetta Ścibiorek, MD

Lead Sponsor: Medical Universtity of Lodz

Collaborator:

More information:https://clinicaltrials.gov/show/NCT00488176

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