UMIN-CTR Clinical Trial

Basic information
Public title	Effects of ebastine on up-regulation of histamine H1 receptor mRNA in the nasal mucosa induced by artificial exposure of Japanese cedar pollen in patients with allergic rhinitis to cedar pollen.
Acronym	Effects of ebastine on up-regulation of histamine H1 receptor mRNA in the nasal mucosa induced by artificial exposure of Japanese cedar pollen in patients with allergic rhinitis to cedar pollen.
Scientific Title	Effects of ebastine on up-regulation of histamine H1 receptor mRNA in the nasal mucosa induced by artificial exposure of Japanese cedar pollen in patients with allergic rhinitis to cedar pollen.
Scientific Title:Acronym	Effects of ebastine on up-regulation of histamine H1 receptor mRNA in the nasal mucosa induced by artificial exposure of Japanese cedar pollen in patients with allergic rhinitis to cedar pollen.
Region	Japan

Condition
Condition	allergic rhinitis
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In the present study, an attempt is made to examine effects of ebastine on up-regulation of histamine H1 receptor mRNA in the nasal mucosa induced by artificial exposure of Japanese cedar pollen in patients with allergic rhinitis to cedar. For this purpose, we use an environmental exposure unit and exposed the subjects to 8000 counts/m3 of Japanese cedar pollen for 3 hours in the off-season. Before exposure of pollen, ebastine was administrate at adose of 10mg, p.o. for 4 days and changes in expression of histamine H1 receptor and allergy-related cytokine mRNA in the nasal mucosa are measured.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	The expression of histamine H1 receptor and allergy-related cytokine mRNA in the nasal mucosa
Key secondary outcomes	The allergic rhinitis symptoms including sneezing, nasal discharge and nasal obstruction

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Ebastine is administrated p.o. at a dose of 10mg to the subjects for 4 days and then the artificial exposure of Japanese cedar pollen at the concentration of 8000 counts/m3.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	Adult patients with allergic rhinitis to cedar pollen
Key exclusion criteria	1) Patients who have ever suffered from adverse event of ebastine. 2) Patients who was excluded by investigators.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Yoshiaki Middle name Last name Kitamura
Organization	University of Tokushima School of Medicine
Division name	Department of Otolaryngology
Zip code	770-8503
Address	3-18-15 Kuramoto, Tokushima 770-8503, Japan
TEL	088-633-7169
Email	ykitamura@tokushima-u.ac.jp

Public contact
Name of contact person	1st name Yoshiaki Middle name Last name Kitamura
Organization	University of Tokushima School of Medicine
Division name	Department of Otolaryngology
Zip code	770-8503
Address	3-18-15 Kuramoto, Tokushima 770-8503, Japan
TEL	088-633-7169
Homepage URL
Email	ykitamura@tokushima-u.ac.jp

Sponsor
Institute	University of Tokushima
Institute
Department

Funding Source
Organization	University of Tokushima
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Committees for Medical Ethics of Tokushima University Hospital
Address	2-50-1 Kuramoto, Tokushima 770-8503, Japan
Tel	088-633-9294
Email	first-ec@clin.med.tokushima-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2012 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2012 Year 09 Month 15 Day
Date of IRB
Anticipated trial start date	2012 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2012 Year 09 Month 20 Day
Last modified on	2022 Year 03 Month 04 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010497