Comparison of the Effect of Montelukast and Cetirizine on Allergic Inflammation in Children With Allergic Rhinitis
Information source: Medical Universtity of Lodz
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Seasonal Allergic Rhinitis
Intervention: montelukast (Drug); cetirizine (Drug); montelukast and cetirizine (Drug); placebo (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Medical Universtity of Lodz Official(s) and/or principal investigator(s):
Violetta Ĺcibiorek, MD, Principal Investigator, Affiliation: Department of Pediatrics and Allergy, Medical University of Lodz, Poland
Iwona Stelmach, MD, PhD, Prof, Study Chair, Affiliation: Department of Pediatrics and Allergy, Medical University of Lodz, Poland
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.
Clinical Details
Official title: Comparison of the Effect of Montelukast and Cetirizine on Allergic Inflammation Measured by Exhaled Nitric Oxide Concentration in Children With Seasonal Allergic Rhinitis
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: exhaled nitric oxide concentration
Secondary outcome: symptoms score (based on PAQLQ), bronchial hyperresponsiveness with methacholine, spirometry, PEFR measurements
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.
Eligibility
Minimum age: 6 Years.
Maximum age: 18 Years.
Gender(s): Both.
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
Locations and Contacts
Department of Pediatrics and Allergy, Medical University of Lodz Lodz, Poland, Lodz 93-513, Poland
Additional Information
Starting date: April 2007
Ending date: August 2007
Last updated: June 19, 2007
|
