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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029942
Receipt No. R000034202
Scientific Title Investigation of asthma-related activating factor for eosinophils, neutrophils, mononuclear cells of healthy volunteers
Date of disclosure of the study information 2018/01/01
Last modified on 2017/11/13

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Basic information
Public title Investigation of asthma-related activating factor for eosinophils, neutrophils, mononuclear cells of healthy volunteers
Acronym Investigation of asthma-related activating factor for eosinophils, neutrophils, mononuclear cells of healthy volunteers
Scientific Title Investigation of asthma-related activating factor for eosinophils, neutrophils, mononuclear cells of healthy volunteers
Scientific Title:Acronym Investigation of asthma-related activating factor for eosinophils, neutrophils, mononuclear cells of healthy volunteers
Region
Japan

Condition
Condition Healthy volunteers
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We examine whether protein that are up-regulated in asthmatics can activate eosinophils, neutrophils or mononuclear cells from healthy volunteers
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Adhesion, superoxide anion generation, or degranulation of eosiniphils or neutrophils. Cytokine production from mononuclear cells.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Presence of asthma-related protein
Interventions/Control_2 Absence of asthma-related protein
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
100 years-old >
Gender Male and Female
Key inclusion criteria Healthy voluteers
Key exclusion criteria Allergic Patients
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuyuki Nakagome
Organization Saitama Medical University
Division name Department of Respiratory Medicine
Zip code
Address 38 Morohongou, Moroyama-machi, Iruma-gun, Saitama
TEL 049-276-1319
Email nakagomek-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuyuki Nakagome
Organization Saitama Medical University
Division name Department of Respiratory Medicine
Zip code
Address 38 Morohongou, Moroyama-machi, Iruma-gun, Saitama
TEL 049-276-1319
Homepage URL
Email nakagomek-tky@umin.ac.jp

Sponsor
Institute Saitama Medical University
Institute
Department

Funding Source
Organization Saitama Medical University
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
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

Other administrative information
Date of disclosure of the study information
2018 Year 01 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 Preinitiation
Date of protocol fixation
2018 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 01 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

Management information
Registered date
2017 Year 11 Month 13 Day
Last modified on
2017 Year 11 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034202

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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