UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033615 |
|---|---|
| Receipt number | R000038319 |
| Scientific Title | Prospective multicenter cohort study on the efficacy and safety of benralizumab in the treatment of severe asthma |
| Date of disclosure of the study information | 2018/08/03 |
| Last modified on | 2018/08/02 23:31:55 |
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Basic information
Public title
Prospective multicenter cohort study on the efficacy and safety of benralizumab in the treatment of severe asthma
Acronym
Prospective multicenter cohort study on the efficacy and safety of benralizumab in the treatment of severe asthma
Scientific Title
Prospective multicenter cohort study on the efficacy and safety of benralizumab in the treatment of severe asthma
Scientific Title:Acronym
Prospective multicenter cohort study on the efficacy and safety of benralizumab in the treatment of severe asthma
Region
| Japan |
Condition
Condition
Bronchial Asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of efficacy and safety of benralizumab in the treatment of severe asthma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Spirometry
Key secondary outcomes
Astma Control Test(ACT), Asthma Control Questionnaire(ACQ), Asthma Quality of Life Questionnaire(AQLQ), FeNO, Objective opinion, Sputum eosinophil counts, Chest X-ray, Chest CT, Respiratory resistance test, Oral corticosteroid dose, Absence of unexpected visit and hospitalization due to asthma exacerbation, Clinical examination, Sinus CT, Safety
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
Benralizumab is given subcutaneously
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 receiving oral corticosteroid daily
2. Patients with increasing of corticosteroid or needing corticosteroid temporalily at least twice a year due to asthma exacerbation
3. Patients with ACT<25 or ACQ>0
Key exclusion criteria
1. Patients with intention to refuse to participate in this research.
2.Patients with a history of hypersensitivity to this drug and the ingredients of this drug.
3. Patients under 20 years old.
4. Patients who may be pregnant.
5. Patients with breastfeeding
6. Patients deemed ineligible by the attending physicians for various
reasons.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Tachiwada |
Organization
University of Occupational and Environmental Health, Japan
Division name
Department of Respiratory Medicine
Zip code
Address
1-1,Iseigaoka,Yahata-nishi-ku, Kitakyushu,Fukuoka,807-8555, Japan
TEL
093-691-7453
kokyu2@mbox.med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Tachiwada |
Organization
University of Occupational and Environmental Health, Japan
Division name
Department of Respiratory Medicine
Zip code
Address
1-1,Iseigaoka,Yahata-nishi-ku, Kitakyushu,Fukuoka,807-8555, Japan
TEL
093-691-7453
Homepage URL
kokyu2@mbox.med.uoeh-u.ac.jp
Sponsor or person
Institute
Department of Respiratory Medicine, University of Occupational and Environmental Health, Japan
Institute
Department
Personal name
Funding Source
Organization
Department of Respiratory Medicine, University of Occupational and Environmental Health, Japan
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 | 08 | Month | 03 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 07 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 08 | Month | 03 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 02 | Day |
Last modified on
| 2018 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038319
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
