UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical effectiveness of 2nd generation antihistamine (Observational Study)
Title of the study (Brief title)	Clinical effectiveness of 2nd generation antihistamine (Observational Study)
Region	Japan

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

Objectives
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

Assessment
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

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
Name of lead principal investigator	Junichi Ito
Organization	Ito ENT Clinic
Division name	Ito ENT Clinic
Address	6-30-26 Chiyoda, Aoi-ku, Shizuoka-shi, Shizuoka
TEL	054-265-1000
Email	itoclinic@rouge.plala.or.jp

Public contact
Name of contact person	Nobuhide Mori
Organization	Mebix, Inc.
Division name	Research Promotion Group
Address	Akasaka Intercity, 1-11-44 Akasaka, Minato-ku, Tokyo
TEL	03-4362-4504
Homepage URL
Email	no-mori@mebix.co.jp

Sponsor
Institute	Ito ENT Clinic
Institute
Department

Funding Source
Organization	Kyorin Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

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	2017 Year 02 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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.

Management information
Registered date	2017 Year 02 Month 01 Day
Last modified on	2018 Year 01 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029827