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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034232
Receipt No. R000039025
Scientific Title Analyses of the skin molecules in patients with severe refractory asthma.
Date of disclosure of the study information 2018/10/01
Last modified on 2018/12/13

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Basic information
Public title Analyses of the skin molecules in patients with severe refractory asthma.
Acronym Analyses of the skin molecules in patients with severe refractory asthma.
Scientific Title Analyses of the skin molecules in patients with severe refractory asthma.
Scientific Title:Acronym Analyses of the skin molecules in patients with severe refractory asthma.
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 benralizumab.
Key exclusion criteria 1.Panelists who have complications such as pneumonitis, infection, and cancer.
2.Panelists who have treated with omarizumab or mepolizumab.
3.Panelists who are regarded as inappropriate in this study.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takayoshi Inoue
Organization Kao Corporation
Division name Biological Science Research
Zip code
Address 2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL +81-285-68-7498
Email inoue.takayoshi@kao.com

Public contact
Name of contact person
1st name
Middle name
Last name Yuya Uehara
Organization Kao Corporation
Division name Biological Science Research
Zip code
Address 2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL +81-285-68-7461
Homepage URL
Email uehara.yuuya@kao.com

Sponsor
Institute Kao Corporation
Institute
Department

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
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 順天堂大学医学部付属順天堂医院(東京都)

Other administrative information
Date of disclosure of the study information
2018 Year 10 Month 01 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 No longer recruiting
Date of protocol fixation
2018 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 10 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 The observational study of the relationship between skin molecules and therapeutic effects in severe refractory asthma.

Management information
Registered date
2018 Year 09 Month 21 Day
Last modified on
2018 Year 12 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039025

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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