Study Of Perennial Allergic Rhinitis In Pediatrics

Condition(s) targeted: Perennial Allergic Rhinitis

Intervention: Cetirizine Dry Syrup (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline

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

Official title: Evaluation of the Efficacy and Safety of Cetirizine Dry Syrup in Children -Suffering From Perennial Allergic Rhinitis-

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: change in the total nasal symptom score (TNSS)

Secondary outcome: - Individual daily nasal symptom score - Investigator global improvement/patient global improvement - Nasal findings - Cetirizine serum concentrations - Adverse events

Minimum age: 3 Years. Maximum age: 14 Years. Gender(s): Both.

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 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.

GSK Clinical Trials Call Center, Hokkaido_2 011, Japan

GSK Clinical Trials Call Center, Tokyo_22 173, Japan

GSK Clinical Trials Call Center, Tokyo_26 173, Japan

GSK Clinical Trials Call Center, Tokyo_18 205, Japan

GSK Clinical Trials Call Center, Saitama_11 350, Japan

GSK Clinical Trials Call Center, Saitama_10 355, Japan

GSK Clinical Trials Call Center, Yamanashi_33 406, Japan

GSK Clinical Trials Call Center, Shizuoka_37 420, Japan

GSK Clinical Trials Call Center, Shizuoka_38 422, Japan

GSK Clinical Trials Call Center, Shizuoka_36 436, Japan

GSK Clinical Trials Call Center, Fukuoka_47 811, Japan

GSK Clinical Trials Call Center, Fukuoka_48 811, Japan

GSK Clinical Trials Call Center, Fukuoka_45 814, Japan

GSK Clinical Trials Call Center, Fukuoka_44 816, Japan

GSK Clinical Trials Call Center, Hokkaido_1 053, Japan

GSK Clinical Trials Call Center, Tokyo_19 101, Japan

GSK Clinical Trials Call Center, Tokyo_21 123, Japan

GSK Clinical Trials Call Center, Tokyo_20 140, Japan

GSK Clinical Trials Call Center, Hokkaido_3 007, Japan

GSK Clinical Trials Call Center, Hokkaido_4 062, Japan

GSK Clinical Trials Call Center, Tokyo_25 206, Japan

GSK Clinical Trials Call Center, Kanagawa_27 222, Japan

GSK Clinical Trials Call Center, Kanagawa_28 224, Japan

GSK Clinical Trials Call Center, Kanagawa_29 224, Japan

GSK Clinical Trials Call Center, Kanagawa_30 229, Japan

GSK Clinical Trials Call Center, Kanagawa_31 240, Japan

GSK Clinical Trials Call Center, Chiba_14 272, Japan

GSK Clinical Trials Call Center, Chiba_16 273, Japan

GSK Clinical Trials Call Center, Chiba_15 279, Japan

GSK Clinical Trials Call Center, Saitama_9 343, Japan

GSK Clinical Trials Call Center, Yamanashi_34 400, Japan

GSK Clinical Trials Call Center, Shizuoka_35 430, Japan

GSK Clinical Trials Call Center, Fukuoka_51 870, Japan

GSK Clinical Trials Call Center, Tokyo_24 154, Japan

GSK Clinical Trials Call Center, Tokyo_23 170, Japan

GSK Clinical Trials Call Center, Chiba_17 272, Japan

GSK Clinical Trials Call Center, Shizuoka_39 420, Japan

GSK Clinical Trials Call Center, Fukuoka_43 816, Japan

GSK Clinical Trials Call Center, Gunma_6 370, Japan

Starting date: July 2005
Last updated: July 31, 2007