Perennial Allergic Rhinitis In Pediatric Subjects

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Rhinitis, Allergic, Perennial

Treatments: Drug: Cetirizine Dry Syrup

Study type: Interventional

Funder types: Industry

Identifiers

NCT00257595

104914

Details and patient eligibility

About

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

Sex: All

Ages: 2 to 14 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)