Perennial Allergic Rhinitis In Pediatric Subjects

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Cetirizine Dry Syrup

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

NCT ID

NCT00257595

First Posted

November 21, 2005

Last Updated

May 3, 2013

Sponsor

GlaxoSmithKline

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

Rhinitis, Allergic, Perennial

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial