Perennial Allergic Rhinitis In Pediatric Subjects

Phase 3

Completed

• Conditions: Rhinitis, Allergic, Perennial

• Registration Number: NCT00257595
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2005-11-21
• Study First Submitted QC: 2005-11-22
• Study First Posted: 2005-11-23
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-03
• Last Update Posted: 2013-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
safety

Secondary Outcome Measures

Name	Time	Method
Total Nasal Symptom Score (TNSS) Individual nasal symptom score total score of 4 individual daily symptom scores Investigator global improvement rating

Trial Locations

Locations (1)

GSK Investigational Site