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History of Changes for Study: NCT00488176
Comparison of the Effect of Montelukast and Cetirizine on Allergic Inflammation in Children With Allergic Rhinitis
Latest version (submitted February 6, 2013) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 19, 2007 None (earliest Version on record)
2 December 23, 2008 Arms and Interventions, Study Status, Study Design, Contacts/Locations and Sponsor/Collaborators
3 February 6, 2013 Recruitment Status, Sponsor/Collaborators, Study Status and Contacts/Locations
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Study NCT00488176
Submitted Date:  June 19, 2007 (v1)

Open or close this module Study Identification
Unique Protocol ID: RNN/94/07KE
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
Secondary IDs:
Open or close this module Study Status
Record Verification: June 2007
Overall Status: Active, not recruiting
Study Start: April 2007
Primary Completion:
Study Completion: August 2007 [Anticipated]
First Submitted: June 19, 2007
First Submitted that
Met QC Criteria:
June 19, 2007
First Posted: June 20, 2007 [Estimate]
Last Update Submitted that
Met QC Criteria:
June 19, 2007
Last Update Posted: June 20, 2007 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Medical University of Lodz
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module 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.

Open or close this module Conditions
Conditions: Seasonal Allergic Rhinitis
Keywords: seasonal allergic rhinitis
children
montelukast
cetirizine
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 4
Interventional Study Model: Parallel Assignment
Number of Arms:
Masking: Double (masked roles unspecified)
Allocation: Randomized
Enrollment: 116 [Actual]
Open or close this module Arms and Interventions
Intervention Details:
Drug: montelukast
Drug: cetirizine
Drug: montelukast and cetirizine
Drug: placebo
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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 Measures:
1. 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) ]

Open or close this module Eligibility
Minimum Age: 6 Years
Maximum Age: 18 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Study Officials: Violetta Ścibiorek, MD
Principal Investigator
Department of Pediatrics and Allergy, Medical University of Lodz, Poland
Iwona Stelmach, MD, PhD, Prof
Study Chair
Department of Pediatrics and Allergy, Medical University of Lodz, Poland
Locations: Poland
Department of Pediatrics and Allergy, Medical University of Lodz Lodz, Poland
Lodz, Poland, 93-513
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Open or close this module References
Citations:
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Available IPD/Information:

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