UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032383 |
|---|---|
| Receipt number | R000036932 |
| Scientific Title | A study to evaluate efficacy of single dose Benralizumab (Fasenra) treatment for difficult-to-treat adult asthma |
| Date of disclosure of the study information | 2018/04/30 |
| Last modified on | 2018/10/25 18:18:23 |
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Basic information
Public title
A study to evaluate efficacy of single dose Benralizumab (Fasenra) treatment for difficult-to-treat adult asthma
Acronym
A study to evaluate efficacy of single dose Benralizumab (Fasenra) treatment for difficult-to-treat adult asthma
Scientific Title
A study to evaluate efficacy of single dose Benralizumab (Fasenra) treatment for difficult-to-treat adult asthma
Scientific Title:Acronym
A study to evaluate efficacy of single dose Benralizumab (Fasenra) treatment for difficult-to-treat adult asthma
Region
| Japan |
Condition
Condition
aspirin exacerbated respiratory disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy of add on Benralizumab for uncontrolled aspirin exacerbated respiratory disease despite using therapeutic agent for asthma including Omalizumab.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
change from baseline to week 4 in Sino-Nasal Outcome Test (SNOT22) score
Key secondary outcomes
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Patients diagnosed with aspirin exacerbated pulmonary disease (AERD) by a systemic aspirin provocation test or a history of characteristic respiratory reactions upon ingestion of COX-1 inhibitors.
2)A blood eosinophil level of 150 cells or more per microliter.
3)Able to provide written, signed and dated informed consent
Key exclusion criteria
1) Previous treatment with benralizumab and mepolizumab in the past year.
2) Unable to provide written, signed and dated informed consent
3) Patients considered at risk of sinusitis and/or nasal polyp surgery during the study period
4) Patients with comorbidities (renal, hepatic, heart, mental, and malignancy etc) requiring treatment
5) Pregnancy, breast-feeding, or potential pregnancy
6) Patients considered unsuitable by the attending physician
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masami Taniguchi |
Organization
Sagamihara National Hospital
Division name
Clinical Research Center for Allergy and Rheumatology
Zip code
Address
18-1 Sakuradai Minami-ku Sagamihara Kanagawa Japan
TEL
042-742-8311
m-taniguchi@sagamihara-hosp.gr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yosuke Kamide |
Organization
Sagamihara National Hospital
Division name
Clinical Research Center for Allergy and Rheumatology
Zip code
Address
18-1 Sakuradai Minami-ku Sagamihara Kanagawa Japan
TEL
042-742-8311
Homepage URL
m08702012@gunma-u.ac.jp
Sponsor or person
Institute
Sagamihara National Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
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 | 04 | Month | 30 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 03 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: Prospective cohort study
Study duration:from 2018/5/1 to 2021/3/31
Subjects:All subjects that our hospital visited by AERD, and met the selection criteria.
Management information
Registered date
| 2018 | Year | 04 | Month | 25 | Day |
Last modified on
| 2018 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036932
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
