Study Of Perennial Allergic Rhinitis In Pediatrics

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Rhinitis, Allergic, Perennial

Treatments

Drug: Cetirizine Dry Syrup

Study type

Interventional

Funder types

Industry

Identifiers

NCT00253058

104912

Details and patient eligibility

About

To verify of cetirizine dry syrup to ketotifen dry syrup in the change of total nasal symptom score (TNSS) over the total treatment period from the score of the baseline assessment period

Sex

All

Ages

3 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 spastic disease such as epilepsy
have a history of drug hypersensitivity
are pregnant, lactating or possibly pregnant female Children
are sensitive 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 or 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.