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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00488176 |
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Date of registration:
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19/06/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Comparison of the Effect of Montelukast and Cetirizine on Allergic Inflammation in Children With Allergic Rhinitis
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Scientific title:
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Comparison of 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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Date of first enrolment:
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April 2007 |
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Target sample size:
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116 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00488176 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Poland
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Contacts
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Name:
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Iwona Stelmach, MD PhD Prof |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Pediatrics and Allergy, Medical University of Lodz, Poland |
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Name:
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Violetta Scibiorek, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Pediatrics and Allergy, Medical University of Lodz, Poland |
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Name:
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Violetta Scibiorek, MD |
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Address:
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Telephone:
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00 48 42 689 59 72 |
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Email:
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alergol@kopernik.lodz.pl |
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Affiliation:
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Name:
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Violetta Scibiorek, MD |
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Address:
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Telephone:
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00 48 42 6895972 |
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Email:
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alergol@kopernik.lodz.pl |
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
6 Years
Age maximum:
18 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Seasonal Allergic Rhinitis
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Intervention(s)
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Drug: montelukast and cetirizine
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Drug: cetirizine
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Drug: montelukast
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Drug: placebo
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Primary Outcome(s)
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exhaled nitric oxide concentration
[Time Frame: baseline (first visit), after 4 weeks (second visit) and after 6 weeks from second visit (third visit)]
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Secondary Outcome(s)
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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)]
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Secondary ID(s)
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RNN/94/07KE
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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