UMIN-CTR Clinical Trial

Public title

Clinical effectiveness of 2nd generation antihistamine
(Observational Study)

Acronym

Clinical effectiveness of 2nd generation antihistamine
(Observational Study)

Scientific Title

Clinical effectiveness of 2nd generation antihistamine
(Observational Study)

Scientific Title:Acronym

Clinical effectiveness of 2nd generation antihistamine
(Observational Study)

Region

Japan

Condition

Seasonal allergic rhinitis

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The aim of this study is to investigate the clinical effectiveness of switching to tricyclic from non-tricyclic structural antihistamic drug in insufficiently patients with seasonal allergic rhinitis.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Change in T4NSS (sneezing, rhinorrhoea, nasal congestion, nasal itching) from week 0 (Visit 1) to week 4 (Visit 3)

Key secondary outcomes

(1) Symptoms, QOL
- T4NSS sub-score: score at each visit
- Score of JRQLQ No.1 items I & II
- Overall condition: face scale of JRQLQ No.1 items III
(2) Treatment satisfaction
- Treatment satisfaction percentage in questionnaire

Other evaluation
(3) Adverse events

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

Age-lower limit

20

years-old

<=

Age-upper limit

80

years-old

>

Gender

Male and Female

Key inclusion criteria

Patients who meet all of the following criteria at the visit1:
(1) Patients who have been diagnosed over 2 years ago with allergic rhinitis to Japanese cedar or other pollens
(2) Patients aged 20 or older and younger than 80 years
(3) Patients with a T4NSS (sneezing, rhinorrhoea, nasal congestion, nasal itching) of 8 or more remaining after at least 2 weeks of taking non-tricyclic structural second generation antihistamic drug, where there is a plan to switch to tricyclic structural antihistamic drug
(4) Patients who can provide written consent for participation in this study themselves and of their own free will with sufficient understanding after receiving sufficient explanation
(5) Patients without communication problems

Key exclusion criteria

Patients who meet the following conditions (at Visit 1) are not selected as subjects:
(1) Patients who have been treated with allergen immunotherapy
(2) Patients with abnormal nasal cavity morphology such as nasal polyps or deviated nasal septum
(3) Patients with severe liver or kidney dysfunction
(4) Patients who are pregnant, breastfeeding, or desire pregnancy during the study period
(5) In addition, patients who are judged to be inappropriate as subjects by the researcher

Target sample size

40

Name of lead principal investigator

1st name
Middle name
Last name	Junichi Ito

Organization

Ito ENT Clinic

Division name

Ito ENT Clinic

Zip code

Address

6-30-26 Chiyoda, Aoi-ku, Shizuoka-shi, Shizuoka

TEL

054-265-1000

Email

itoclinic@rouge.plala.or.jp

Name of contact person

1st name
Middle name
Last name	Nobuhide Mori

Organization

Mebix, Inc.

Division name

Research Promotion Group

Zip code

Address

Akasaka Intercity, 1-11-44 Akasaka, Minato-ku, Tokyo

TEL

03-4362-4504

Homepage URL

Email

no-mori@mebix.co.jp

Institute

Ito ENT Clinic

Institute

Department

Personal name

Organization

Kyorin Pharmaceutical Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

02

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2017

Year

01

Month

10

Day

Date of IRB

Anticipated trial start date

2017

Year

02

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Prospective multicenter observational study
Registration period: 1st of February 2017 to 31st of March 2017
Study period: 1st of February 2017 to 30th of April 2017
Study period: 4 weeks.

Registered date

2017

Year

02

Month

01

Day

Last modified on

2018

Year

01

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029827