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Perennial Allergic Rhinitis In Pediatric Subjects

Primary Purpose

Rhinitis, Allergic, Perennial

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Cetirizine Dry Syrup
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rhinitis, Allergic, Perennial focused on measuring Perennial Allergic Rhinitis pediatric

Eligibility Criteria

2 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • GSK Investigational Site

Outcomes

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

Full Information

First Posted
November 21, 2005
Last Updated
May 3, 2013
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00257595
Brief Title
Perennial Allergic Rhinitis In Pediatric Subjects
Official Title
Long-term Study of Cetirizine Dry Syrup in Children. Suffering From Perennial Allergic Rhinitis.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinitis, Allergic, Perennial
Keywords
Perennial Allergic Rhinitis pediatric

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Cetirizine Dry Syrup
Primary Outcome Measure Information:
Title
safety
Secondary Outcome Measure Information:
Title
Total Nasal Symptom Score (TNSS) Individual nasal symptom score total score of 4 individual daily symptom scores Investigator global improvement rating

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site

12. IPD Sharing Statement

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Perennial Allergic Rhinitis In Pediatric Subjects

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