Comparison of the Effect of Montelukast and Cetirizine on Allergic Inflammation in Children With Allergic Rhinitis
This study is currently recruiting participants.
Verified February 2013 by Medical Universtity of Lodz
Sponsor:
Medical Universtity of Lodz
Information provided by (Responsible Party):
Iwona Stelmach, Medical Universtity of Lodz
ClinicalTrials.gov Identifier:
NCT00488176
First received: June 19, 2007
Last updated: February 6, 2013
Last verified: February 2013
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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.
| Condition | Intervention | Phase |
|---|---|---|
|
Seasonal Allergic Rhinitis |
Drug: montelukast Drug: cetirizine Drug: montelukast and cetirizine Drug: placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Medical Universtity of Lodz:
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 ]
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 ]
| Estimated Enrollment: | 116 |
| Study Start Date: | April 2007 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
monteluksat sodium
|
Drug: montelukast
montelukast sodium
Other Name: montelukast sodium
|
|
Active Comparator: 2
cetirizine
|
Drug: cetirizine
cetirizine
Other Name: cetirizine
|
|
Active Comparator: 3
montelukast sodium and cetirizine
|
Drug: montelukast and cetirizine
montelukast and cetirizine
Other Name: montelukast and cetirizine
|
|
Placebo Comparator: 4
placebo
|
Drug: placebo
placebo
Other Name: placebo
|
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| Ages Eligible for Study: | 6 Years to 18 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00488176
Contacts
| Contact: Violetta Ścibiorek, MD | 00 48 42 6895972 | alergol@kopernik.lodz.pl |
Locations
| Poland | |
| Department of Pediatrics and Allergy, Medical University of Lodz Lodz, Poland | Recruiting |
| Lodz, Poland, 93-513 | |
| Contact: Violetta Ścibiorek, MD 00 48 42 689 59 72 alergol@kopernik.lodz.pl | |
| Principal Investigator: Iwona Stelmach, MD, PhD, Prof | |
Sponsors and Collaborators
Medical Universtity of Lodz
Investigators
| Principal Investigator: | Violetta Ścibiorek, MD | Department of Pediatrics and Allergy, Medical University of Lodz, Poland |
| Study Chair: | Iwona Stelmach, MD PhD Prof | Department of Pediatrics and Allergy, Medical University of Lodz, Poland |
More Information
No publications provided
| Responsible Party: | Iwona Stelmach, MD, PhD, Professor, Medical Universtity of Lodz |
| ClinicalTrials.gov Identifier: | NCT00488176 History of Changes |
| Other Study ID Numbers: | RNN/94/07KE |
| Study First Received: | June 19, 2007 |
| Last Updated: | February 6, 2013 |
| Health Authority: | Poland: Ministry of Health |
Keywords provided by Medical Universtity of Lodz:
|
seasonal allergic rhinitis children montelukast cetirizine |
Additional relevant MeSH terms:
|
Rhinitis, Allergic, Seasonal Inflammation Rhinitis Nose Diseases Respiratory Tract Diseases Respiratory Hypersensitivity Otorhinolaryngologic Diseases Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Pathologic Processes Respiratory Tract Infections Cetirizine Montelukast Anti-Allergic Agents |
Therapeutic Uses Pharmacologic Actions Histamine H1 Antagonists, Non-Sedating Histamine H1 Antagonists Histamine Antagonists Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Leukotriene Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Asthmatic Agents Respiratory System Agents |
ClinicalTrials.gov processed this record on May 23, 2013