Perennial Allergic Rhinitis In Pediatric Subjects

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Cetirizine

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.