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Perennial Allergic Rhinitis In Pediatric Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00257595
First received: November 21, 2005
Last updated: May 3, 2013
Last verified: May 2013
History of Changes
  Purpose

To assess the safety of long-term use of cetirizine dry syrup in children with perennial allergic rhinitis.


Condition Intervention Phase
Rhinitis, Allergic, Perennial
 Drug: Cetirizine Dry Syrup
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Long-term Study of Cetirizine Dry Syrup in Children. Suffering From Perennial Allergic Rhinitis.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • safety

Secondary Outcome Measures:
  • Total Nasal Symptom Score (TNSS) Individual nasal symptom score total score of 4 individual daily symptom scores Investigator global improvement rating

Estimated Enrollment: 30
Study Start Date: August 2005
Intervention Details:
    Drug: Cetirizine Dry Syrup
    Other Name: Cetirizine Dry Syrup
  Eligibility

Ages Eligible for Study:   2 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children with perennial allergic rhinitis.
  • Giving informed consent.
  • Children with a positive response to specific IgE antibody test.
  • Children assessed as positive in the nasal eosinophil count.
  • Children whose severity score of nasal symptom is 4 or higher.

Exclusion criteria:

  • have a history of drug hypersensitivity.
  • are pregnant, lactating or possibly pregnant female children.
  • Sensitivity to pollen as a duplicate allergen and whose treatment periods are thought in the pollen dispersion periods.
  • have vasomotor rhinitis and eosinophilic rhinitis.
  • have asthma that requires the treatment with corticosteroid.
  • have inappropriate complication of nasal disorder that may influence on the evaluation of the study drugs.
  • have complicated with atopic dermatitis or urticaria that requires the treatment with antihistamine preparation.
  • have started specific desensitization treatment.
  • nonspecific modulation treatment but who have not reached the maintenance level of treatment.
  • have received surgical treatment for reduction and modulation of nasal mucosa.
  • redintegration therapy of nasal cavity to improve the degree of nasal airway.
  • surgical operation to improve rhinorrhea.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00257595

Locations
Spain
GSK Investigational Site
Unknown, Spain
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00257595     History of Changes
Other Study ID Numbers: 104914
Study First Received: November 21, 2005
Last Updated: May 3, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:
Perennial Allergic Rhinitis pediatric

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Cetirizine
 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

ClinicalTrials.gov processed this record on May 19, 2013