NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2080221241

Registered date:14/09/2010

Basic Information

Recruitment status
Health condition(s) or Problem(s) studiedSeasonal Allergic Rhinitis
Date of first enrollment14/09/2010
Target sample size48
Countries of recruitment
Study typeInterventional
Intervention(s)investigational material(s) Generic name etc : Z-207 INN of investigational material : Therapeutic category code : 449 Other antiallergic agents Dosage and Administration for Investigational material : Z-207 ( 0.6 mL, 1.0 mL, 2.0 mL ) , a single injection into the mucosa of both inferior turbinates control material(s) Generic name etc : Placebo INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : Placebo 2.0 mL, a single injection into the mucosa of both inferior turbinates

Outcome(s)

Primary OutcomeTotal nasal symptom score under exposure to allergen using pollen challenge chamber, and nasal symptom score natural exposure to allergen during the pollen season
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 64age old
GenderBoth
Include criteriaPatient with history of moderate to sever seasonal allergic rhinitis for at least 2 years Patient with positive reaction for Radio Allergen Sorbent Test using Japanease ceder pollen Patient exhibit both a total nasal symptom score of at least 4, and a nasal obstruction score of at least 2 under exposure to allergen using pollen challenge chamber ( Total nasal symptom score is the sum of sneezing, nasal discharge, nasal obstruction which has been scored on a scale from 0 to 4 )
Exclude criteriaPatient with positive reaction for Radio Allergen Sorbent Test for house dust mite Patient with positive reaction for Radio Allergen Sorbent Test for orchard grass pollen Patient who never received medical drug therapy for allergic rhinitis

Related Information

Contact

Public contact
Name
Address 03-5644-7053
Telephone
E-mail
Affiliation Zeria Pharmaceutical Co., Ltd.
Scientific contact
Name
Address
Telephone
E-mail
Affiliation