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. |
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Condition | Seasonal Allergic Rhinitis |
Intervention | Drug: montelukast Drug: cetirizine Drug: montelukast and cetirizine Drug: placebo |
Phase | Phase 4 |
Sponsor | Medical Universtity of Lodz |
Responsible Party | Medical Universtity of Lodz |
ClinicalTrials.gov Identifier | NCT00488176 |
First Received | June 19, 2007 |
Last Updated | February 6, 2013 |
Last verified | February 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | June 19, 2007 |
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Last Updated Date | February 6, 2013 |
Start Date | April 2007 |
Estimated Primary Completion Date | December 2013 |
Current Primary Outcome Measures | exhaled 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 Measures | symptoms 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 Title | Comparison of the Effect of Montelukast and Cetirizine on Allergic Inflammation in Children With Allergic Rhinitis |
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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 |
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 Type | Interventional |
Study Phase | Phase 4 |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment |
Condition | Seasonal Allergic Rhinitis |
Intervention | Drug: 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) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Recruiting |
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Estimated Enrollment | 116 |
Estimated Completion Date | December 2013 |
Estimated Primary Completion Date | November 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 |
Gender | Both |
Ages | 6 Years |
Accepts Healthy Volunteers | No |
Contacts | Contact: Violetta Ścibiorek, MD 00 48 42 6895972 alergol@kopernik.lodz.pl |
Location Countries | Poland |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00488176 |
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Other Study ID Numbers | RNN/94/07KE |
Has Data Monitoring Committee | Yes |
Information Provided By | Medical Universtity of Lodz |
Study Sponsor | Medical Universtity of Lodz |
Collaborators | Not 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 Date | February 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.plPrincipal Investigator: Iwona Stelmach, MD, PhD, Prof Recruiting |
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