UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008951
Receipt number R000010497
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.
Date of disclosure of the study information 2012/10/01
Last modified on 2022/03/04 11:25:54

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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 or person

Institute

University of Tokushima

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010497


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name