Comparison of the Effect of Montelukast and Cetirizine on Allergic Inflammation in Children With Allergic Rhinitis - Full Text View

Sponsor:	Medical Universtity of Lodz
Information provided by:	Medical Universtity of Lodz
ClinicalTrials.gov Identifier:	NCT00488176

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 IV

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:

MedlinePlus related topics: Allergy Hay Fever

Drug Information available for: Cetirizine Cetirizine hydrochloride Montelukast sodium Montelukast

U.S. FDA Resources

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 2009
Estimated Primary Completion Date:	November 2009 (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

Locations

Poland
Department of Pediatrics and Allergy, Medical University of Lodz Lodz, Poland
Lodz, Poland, 93-513

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, Prof., Department of Pediatrics and Allergy, Medical University of Lodz, Poland.
ClinicalTrials.gov Identifier:	NCT00488176 History of Changes
Other Study ID Numbers:	RNN/94/07KE
Study First Received:	June 19, 2007
Last Updated:	December 23, 2008
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 February 09, 2012