UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036116 |
|---|---|
| Receipt number | R000041141 |
| Scientific Title | Analyses of the skin molecules in patients with severe refractory asthma(2). |
| Date of disclosure of the study information | 2019/03/08 |
| Last modified on | 2020/09/15 09:12:23 |
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Basic information
Public title
Analyses of the skin molecules in patients with severe refractory asthma(2).
Acronym
Analyses of the skin molecules in patients with severe refractory asthma(2).
Scientific Title
Analyses of the skin molecules in patients with severe refractory asthma(2).
Scientific Title:Acronym
Analyses of the skin molecules in patients with severe refractory asthma(2).
Region
| Japan |
Condition
Condition
Bronchial asthma
Classification by specialty
| Pneumology | Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the skin molecules in patients with severe refractory asthma.
Basic objectives2
Others
Basic objectives -Others
The observational study of the relationship between skin molecules and therapeutic effects in severe refractory asthma.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relationship between skin molecules and therapeutic effects in severe refractory asthma.
Key secondary outcomes
The relationship of the molecules between skin and blood.
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.Panelists with severe refractory asthma based on ASTHMA PREVENTION AND MANAGEMENT GUIDELINE 2015.
2.Panelists who are ambulatory patients of Juntendo University hospital.
3.Panelists who are ages 20 and over.
4.Panelists who agree to have their typical daily routines.
5.Panelists who have uncontrollable asthmatic symptoms by conventional therapy, and need administration of dupilumab.
Key exclusion criteria
1.Panelists who have complications such as pneumonitis, infection, and cancer.
2.Panelists who have treated with antibody drugs except for dupilumab.
3.Panelists who are regarded as inappropriate in this study.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Takayoshi |
| Middle name | |
| Last name | Inoue |
Organization
Kao Corporation
Division name
Biological Science Research
Zip code
321-3497
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
+81-285-68-7498
inoue.takayoshi@kao.com
Public contact
Name of contact person
| 1st name | Yuya |
| Middle name | |
| Last name | Uehara |
Organization
Kao Corporation
Division name
Biological Science Research
Zip code
321-3497
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
+81-285-68-7461
Homepage URL
uehara.yuuya@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Juntendo University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Human Research Ethics Committee, Kao Corporation
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel
+81-3-5630-9220
uesaka.toshio@kao.com
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
順天堂大学医学部付属 順天堂医院（東京都）、練馬病院（東京都）、江東高齢者医療センター（東京都）、浦安病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 03 | Month | 08 | 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
| 2019 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The observational study of the relationship between skin molecules and therapeutic effects in severe refractory asthma.
Management information
Registered date
| 2019 | Year | 03 | Month | 07 | Day |
Last modified on
| 2020 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041141
