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

Sponsored by:	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:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
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: 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
1: Active Comparator monteluksat sodium	Drug: montelukast montelukast sodium
2: Active Comparator cetirizine	Drug: cetirizine cetirizine
3: Active Comparator montelukast sodium and cetirizine	Drug: montelukast and cetirizine montelukast and cetirizine
4: Placebo Comparator placebo	Drug: placebo 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:	Department of Pediatrics and Allergy, Medical University of Lodz, Poland. ( Iwona Stelmach MD, PhD, Prof. )
Study ID Numbers:	RNN/94/07KE
Study First Received:	June 19, 2007
Last Updated:	December 23, 2008
ClinicalTrials.gov Identifier:	NCT00488176 History of Changes
Health Authority:	Poland: Ministry of Health

Keywords provided by Medical Universtity of Lodz:

seasonal allergic rhinitis
children
montelukast
cetirizine

Study placed in the following topic categories:

Neurotransmitter Agents
Otorhinolaryngologic Diseases
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Rhinitis
Anti-Allergic Agents
Cetirizine
Hormones
Leukotriene Antagonists
Histamine
Inflammation

Nitric Oxide
Montelukast
Hypersensitivity
Histamine Antagonists
Respiratory Tract Diseases
Respiratory Tract Infections
Rhinitis, Allergic, Seasonal
Hypersensitivity, Immediate
Histamine phosphate
Histamine H1 Antagonists
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Rhinitis
Leukotriene Antagonists
Hypersensitivity
Pathologic Processes
Respiratory Tract Infections
Respiratory Tract Diseases
Therapeutic Uses
Otorhinolaryngologic Diseases
Immune System Diseases

Anti-Asthmatic Agents
Histamine Agents
Anti-Allergic Agents
Cetirizine
Nose Diseases
Pharmacologic Actions
Inflammation
Montelukast
Histamine Antagonists
Rhinitis, Allergic, Seasonal
Hypersensitivity, Immediate
Histamine H1 Antagonists
Histamine H1 Antagonists, Non-Sedating
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on September 01, 2009