UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective study on identification of effectiveness, safety and effect predictors of benralizumab for bronchial asthma
Title of the study (Brief title)	J-BEST
Region	Japan

Condition
Condition	bronchial asthma
Classification by specialty	Medicine in general Pneumology Clinical immunology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Identification of effectiveness, safety and effect predictors of benralizumab for bronchial asthma
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Relationship between effect predictors before administration and improvement of symptoms after 12 weeks
Key secondary outcomes	1. Improvement of questionnaire on quality of life (AQLQ), asthma control test (ACT) score, exacerbation frequency, respiratory function one second amount (FEV 1), divided into two groups at the median of various effect predicting factors before administration 2. The relationship between the variation of various indices and the improvement of AQLQ score, ACT score, exacerbation frequency, FEV 1 3. The time course of various effect predictors 4. Asthma control (the ratio of the number of strokes up to the 12th week, the ratio of unscheduled outpatient visits to the 12th week (including emergency outpatient visits)) 5. Effect of drug reduction scale 6. The incidence of adverse events of Grade 1 or higher during treatment 7. When continuing treatment with benralizumab after 12 weeks, adverse events from the onset of treatment of benralizumab to one year

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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients diagnosed with bronchial asthma according to general allergy guideline 2016 2) Patients with bronchial asthma using high-dose inhaled corticosteroids and long-acting beta 2 agonists 3) Patients who obtain written consent regarding the participation of this study
Key exclusion criteria	1) Patients who have previously received benralizumab 2) Patients with severe complications such as heart disease, liver disease or kidney failure 3) Patients judged unsuitable as subjects by doctor's judgment
Target sample size	25

Research contact person
Name of lead principal investigator	Takehiro Izumo
Organization	Japanese Red Cross Medical Center
Division name	Respiratory Medicine
Address	4-1-22, Hiroo, Shibuya-ku, Tokyo, Japan
TEL	03-3400-1311
Email	drtake1118@gmail.com

Public contact
Name of contact person	Takehiro Izumo
Organization	Japanese Red Cross Medical Center
Division name	Respiratory Medicine
Address	4-1-22, Hiroo, Shibuya-ku, Tokyo, Japan
TEL	03-3400-1311
Homepage URL
Email	drtake1118@gmail.com

Sponsor
Institute	Japanese Red Cross Medical Center
Institute
Department

Funding Source
Organization	Japanese Red Cross Medical Center
Organization
Division
Category of Funding Organization	Self funding
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	2018 Year 03 Month 28 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 03 Month 27 Day
Anticipated trial start date	2018 Year 04 Month 18 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 study

Management information
Registered date	2018 Year 03 Month 28 Day
Last modified on	2018 Year 04 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036340