UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analysis of bilastine efficacy against chronic cough in patients with allergic rhinitis or atopic dermatitis.
Title of the study (Brief title)	Analysis of bilastine efficacy against allergic cough.
Region	Japan

Condition
Condition	atopic cough
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study was to evaluate the efficacy of bilastine against chronic cough in patients with allergic rhinitis or atopic dermatitis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Japan-Leicester Cough Questionnaire
Key secondary outcomes	cough severity visual analogue scale and adverse effect.

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	hisatmine H1 receptor antagonist:bilastine
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1)chronic non-productive cough 2)absence of wheeze and dyspnea 3)resistant to bronchodilator therapy 4)past history and/or complication of allergic rhinitis or atopic dermatitis 5)no medication that causes cough (ACE inhibitor, etc.) 6)over 20 years old 7)written consent form
Key exclusion criteria	1)abnormal findings of chest X-ray 2)patients judged inappropriate by physician
Target sample size	25

Research contact person
Name of lead principal investigator	Tatsuya Nagano
Organization	Kobe University Graduate School of Medicine
Division name	Division of Respiratory Medicine, Department of Internal Medicine
Address	7-5-1 Kusunokicho, Chuo-ku, Kobe, Hyogo 650-0017, Japan
TEL	0783825660
Email	tnagano@med.kobe-u.ac.jp

Public contact
Name of contact person	Yuichiro Yasuda
Organization	Kobe University Graduate School of Medicine
Division name	Division of Respiratory Medicine, Department of Internal Medicine
Address	7-5-1 Kusunokicho, Chuo-ku, Kobe, Hyogo 650-0017, Japan
TEL	0783825660
Homepage URL
Email	yyasuda@med.kobe-u.ac.jp

Sponsor
Institute	Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization	This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors.
Organization
Division
Category of Funding Organization	Other
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	神戸大学医学部附属病院（兵庫県）、明石医療センター（兵庫県）、加古川中央市民病院（兵庫県）、愛仁会　高槻病院（大阪府）、北播磨総合医療センター（兵庫県）、神戸医療センター（兵庫県）、なかじま内科クリニック（兵庫県）、中谷病院（兵庫県）、陰下内科（兵庫県）

Other administrative information
Date of disclosure of the study information	2018 Year 09 Month 15 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 10 Month 01 Day
Anticipated trial start date	2018 Year 10 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

Management information
Registered date	2018 Year 08 Month 20 Day
Last modified on	2018 Year 08 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038473