Comparison of the Effect of Montelukast and Cetirizine on Allergic Inflammation in Children With Allergic Rhinitis
Primary Purpose
Seasonal Allergic Rhinitis
Status
Unknown status
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
montelukast
cetirizine
montelukast and cetirizine
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Seasonal Allergic Rhinitis focused on measuring seasonal allergic rhinitis, children, montelukast, cetirizine
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
Sites / Locations
- Department of Pediatrics and Allergy, Medical University of Lodz Lodz, PolandRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
1
2
3
4
Arm Description
monteluksat sodium
cetirizine
montelukast sodium and cetirizine
placebo
Outcomes
Primary Outcome Measures
exhaled nitric oxide concentration
Secondary Outcome Measures
symptoms score (based on PAQLQ), bronchial hyperresponsiveness with methacholine, spirometry, PEFR measurements
Full Information
NCT ID
NCT00488176
First Posted
June 19, 2007
Last Updated
February 6, 2013
Sponsor
Medical University of Lodz
1. Study Identification
Unique Protocol Identification Number
NCT00488176
Brief Title
Comparison of the Effect of Montelukast and Cetirizine on Allergic Inflammation in Children With Allergic Rhinitis
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 Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Unknown status
Study Start Date
April 2007 (undefined)
Primary Completion Date
November 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Lodz
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Allergic Rhinitis
Keywords
seasonal allergic rhinitis, children, montelukast, cetirizine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
116 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
monteluksat sodium
Arm Title
2
Arm Type
Active Comparator
Arm Description
cetirizine
Arm Title
3
Arm Type
Active Comparator
Arm Description
montelukast sodium and cetirizine
Arm Title
4
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
montelukast
Other Intervention Name(s)
montelukast sodium
Intervention Description
montelukast sodium
Intervention Type
Drug
Intervention Name(s)
cetirizine
Intervention Description
cetirizine
Intervention Type
Drug
Intervention Name(s)
montelukast and cetirizine
Intervention Description
montelukast and cetirizine
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
exhaled nitric oxide concentration
Time Frame
baseline (first visit), after 4 weeks (second visit) and after 6 weeks from second visit (third visit)
Secondary Outcome Measure Information:
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Violetta Ścibiorek, MD
Phone
00 48 42 6895972
Email
alergol@kopernik.lodz.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Violetta Ścibiorek, MD
Organizational Affiliation
Department of Pediatrics and Allergy, Medical University of Lodz, Poland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Iwona Stelmach, MD PhD Prof
Organizational Affiliation
Department of Pediatrics and Allergy, Medical University of Lodz, Poland
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Pediatrics and Allergy, Medical University of Lodz Lodz, Poland
City
Lodz
ZIP/Postal Code
93-513
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Violetta Ścibiorek, MD
Phone
00 48 42 689 59 72
Email
alergol@kopernik.lodz.pl
First Name & Middle Initial & Last Name & Degree
Iwona Stelmach, MD, PhD, Prof
12. IPD Sharing Statement
Learn more about this trial
Comparison of the Effect of Montelukast and Cetirizine on Allergic Inflammation in Children With Allergic Rhinitis
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