Perennial Allergic Rhinitis In Pediatric Subjects - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00257595

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

Drug Information available for: Cetirizine Cetirizine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, 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:	August 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

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	104914, RPCE04E1702/A00388
Study First Received:	November 21, 2005
Last Updated:	October 15, 2008
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 January 13, 2009