Comparison of the Effect of Montelukast and Cetirizine on Allergic Inflammation in Children With Allergic Rhinitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Medical Universtity of Lodz
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Rhinitis, Allergic, Perennial
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
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 18, 2014