Perennial Allergic Rhinitis In Pediatric Subjects

Rhinitis, Allergic, Perennial Clinical Trial

Official title:

Long-term Study of Cetirizine Dry Syrup in Children. Suffering From Perennial Allergic Rhinitis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00257595
• Other study ID #: 104914
• Status: Completed
• Phase: Phase 3
• First received: November 21, 2005
• Last updated: May 3, 2013
• Start date: August 2005

Study information

• Verified date: May 2013
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 14 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic, Perennial

Intervention

Drug:
• Cetirizine Dry Syrup

Locations

Country	Name	City	State
Spain	GSK Investigational Site	Unknown

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety
Secondary	Total Nasal Symptom Score (TNSS) Individual nasal symptom score total score of 4 individual daily symptom scores Investigator global improvement rating