UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000012185
Receipt No. R000014238
Scientific Title A Danger Signal, Uric Acid/ATP, Attracts and Activates Human Eosinophils
Date of disclosure of the study information 2013/10/31
Last modified on 2019/07/16 (Ver. 6)

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Basic information
Public title A Danger Signal, Uric Acid/ATP, Attracts and Activates Human Eosinophils
Acronym Danger signal induced eosinophils activation
Scientific Title A Danger Signal, Uric Acid/ATP, Attracts and Activates Human Eosinophils
Scientific Title:Acronym Danger signal induced eosinophils activation
Region
Japan

Condition
Condition bronchial asthma, eosinophilc pneumonia, Hypersensitivity Pneumonitis, sarcoidosis, pneumonia
Classification by specialty
Pneumology Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 whether Danger signal can exist in bronchoalveolar lavage fluid for respiratory illness.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Analysis of the bronchoalveolar lavage fluid.
Key secondary outcomes

Base
Study type Others,meta-analysis etc

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
16 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria The patient that respiratory internal medicine is hospitalized in the past and enforces examination with broncho fiber scope, and there is a preservation specimen of the bronchoalveolar lavage fluid
Key exclusion criteria The patient who cannot confirm the details of the medical history
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Takehito
Middle name
Last name Kobayashi
Organization Saitama Medical University Hospital
Division name Department of General Internal Medicine
Zip code 350-0495
Address 38 Morohongo Moroyamamachi Irumagun Saitama, Japan
TEL 049-276-1667
Email kobatake@saitama-med.ac.jp

Public contact
Name of contact person
1st name Takehito
Middle name
Last name Kobayashi
Organization Saitama Medical University Hospital
Division name Department of General Internal
Zip code 350-0495
Address 38 Morohongo Moroyamamachi Irumagun Saitama, Japan
TEL 049-276-1667
Homepage URL
Email kobatake@saitama-med.ac.jp

Sponsor
Institute Saitama Medical University Hospital
Institute
Department

Funding Source
Organization The Ministry of Education, Culture, Sports, Science and Technology(MEXT)
Grant-in-Aid for Scientific Research (KAKENHI)
Grant-in-Aid for Young Scientists(B)
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 Saitama Medical University Hospital Hospital IRB
Address 38 Morohongo Moroyamamachi Irumagun Saitama, Japan
Tel 049-276-1354
Email hirb@saitama-med.ac.jp

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
2013 Year 10 Month 31 Day

Related information
URL releasing protocol https://www.ncbi.nlm.nih.gov/pubmed/26344078 , https://www.ncbi.nlm.nih.gov/pubmed/28705588
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/26344078 , https://www.ncbi.nlm.nih.gov/pubmed/28705588
Number of participants that the trial has enrolled 30
Results 
The substance released by tissue invasion and affecting the immune response is called Danger signal.
The Danger signal UA / ATP induces eosinophil activation.
In vitro, UA / ATP induced adhesion reaction, migration reaction, activation of eosinophils.
In Vivo, consistent results were obtained by analysis of BALF of AEP.
Results date posted
2019 Year 07 Month 16 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2016 Year 03 Month 31 Day
Baseline Characteristics 
Eosinophilic pneumonia
Participant flow 
Healthy person
hospitalized patient
Adverse events 
nothing
Outcome measures 
Clinical symptoms
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 04 Month 01 Day
Date of IRB
2015 Year 03 Month 31 Day
Anticipated trial start date
2013 Year 04 Month 01 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
2017 Year 03 Month 31 Day
Date trial data considered complete
2017 Year 03 Month 31 Day
Date analysis concluded
2017 Year 03 Month 31 Day

Other
Other related information Retrospective study

Management information
Registered date
2013 Year 10 Month 31 Day
Last modified on
2019 Year 07 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014238