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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031951
Receipt No. R000036340
Scientific Title Prospective study on identification of effectiveness, safety and effect predictors of benralizumab for bronchial asthma
Date of disclosure of the study information 2018/03/28
Last modified on 2018/04/18

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Basic information
Public title Prospective study on identification of effectiveness, safety and effect predictors of benralizumab for bronchial asthma
Acronym J-BEST
Scientific Title Prospective study on identification of effectiveness, safety and effect predictors of benralizumab for bronchial asthma
Scientific Title:Acronym 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
1st name
Middle name
Last name Takehiro Izumo
Organization Japanese Red Cross Medical Center
Division name Respiratory Medicine
Zip code
Address 4-1-22, Hiroo, Shibuya-ku, Tokyo, Japan
TEL 03-3400-1311
Email drtake1118@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Takehiro Izumo
Organization Japanese Red Cross Medical Center
Division name Respiratory Medicine
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Open public recruiting
Date of protocol fixation
2018 Year 03 Month 27 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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