UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031951 |
|---|---|
| Receipt number | 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 15:08:11 |
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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
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
drtake1118@gmail.com
Sponsor or person
Institute
Japanese Red Cross Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036340
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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