Perennial Allergic Rhinitis In Pediatric Subjects - Full Text View

Purpose

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

Condition	Intervention	Phase
Perennial Allergic Rhinitis	Drug: Cetirizine Dry Syrup	Phase III

ChemIDplus related topics:

Cetirizine Cetirizine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:	Long-Term Study of Cetirizine Dry Syrup in Children. Suffering From Perennial Allergic Rhinitis.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

safety

Secondary Outcome Measures:

Total Nasal Symptom Score (TNSS) Individual nasal symptom score total score of 4 individual daily symptom scores Investigator global improvement rating

Estimated Enrollment:	30
Study Start Date:	July 2005

Eligibility

Ages Eligible for Study:	2 Years to 14 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00257595

Locations


Japan
	GSK Clinical Trials Call Center
	Fukuoka_18, Japan, 812
	GSK Clinical Trials Call Center
	Yamanashi_16, Japan, 400
	GSK Clinical Trials Call Center
	Gunma_1, Japan, 370
	GSK Clinical Trials Call Center
	Chiba_2, Japan, 261
	GSK Clinical Trials Call Center
	Chiba_3, Japan, 272
	GSK Clinical Trials Call Center
	Chiba_4, Japan, 279
	GSK Clinical Trials Call Center
	Chiba_5, Japan, 272
	GSK Clinical Trials Call Center
	Tokyo_6, Japan, 101
	GSK Clinical Trials Call Center
	Tokyo_7, Japan, 140
	GSK Clinical Trials Call Center
	Shizuoka_17, Japan, 420
	GSK Clinical Trials Call Center
	Kanagawa_9, Japan, 222
	GSK Clinical Trials Call Center
	Kanagawa_10, Japan, 224
	GSK Clinical Trials Call Center
	Kanagawa_11, Japan, 224
	GSK Clinical Trials Call Center
	Kanagawa_12, Japan, 229
	GSK Clinical Trials Call Center
	Kanagawa_14, Japan, 213
	GSK Clinical Trials Call Center
	Yamanashi_15, Japan, 406
	GSK Clinical Trials Call Center
	Kanagawa_13, Japan, 240
	GSK Clinical Trials Call Center
	Tokyo_8, Japan, 173

Sponsors and Collaborators

GlaxoSmithKline

UCB

Investigators


Study Director:	GSK Clinical Trials, MD	GlaxoSmithKline

More Information

Study ID Numbers:	104914, RPCE04E1702/A00388
First Received:	November 21, 2005
Last Updated:	July 31, 2007
ClinicalTrials.gov Identifier:	NCT00257595
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:

Perennial Allergic Rhinitis pediatric

Study placed in the following topic categories:

Hypersensitivity

Otorhinolaryngologic Diseases

Respiratory Tract Infections

Respiratory Tract Diseases

Rhinitis, Allergic, Perennial

Hypersensitivity, Immediate

Histamine phosphate

Rhinitis

Cetirizine

Histamine

Respiratory Hypersensitivity

Additional relevant MeSH terms:

Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action

Histamine Antagonists

Immune System Diseases

Therapeutic Uses

Physiological Effects of Drugs

Histamine Agents

Histamine H1 Antagonists

Anti-Allergic Agents

Histamine H1 Antagonists, Non-Sedating

Pharmacologic Actions

Nose Diseases

ClinicalTrials.gov processed this record on September 19, 2008

Sponsors and Collaborators:	GlaxoSmithKline UCB
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00257595