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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033420
Receipt No. R000038106
Scientific Title Detection and kinetics of IL-38 positive cells in induced sputum in atopic mild adult asthmatics after allergen challenge
Date of disclosure of the study information 2018/08/01
Last modified on 2019/07/11

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Basic information
Public title Detection and kinetics of IL-38 positive cells in induced sputum in atopic mild adult asthmatics after allergen challenge
Acronym IL-38 positive cells in atopic asthma
Scientific Title Detection and kinetics of IL-38 positive cells in induced sputum in atopic mild adult asthmatics after allergen challenge
Scientific Title:Acronym IL-38 positive cells in atopic asthma
Region
Japan

Condition
Condition Atopic mild adult asthma
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Detection of IL-38 positive cells in induced sputum and peripheral blood in patients with asthma and healthy subjects.
Basic objectives2 Others
Basic objectives -Others Kinetics of IL-38 positive cells in induced sputum and peripheral blood in patients with asthma pre and after allergen challenge
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Primary endpoint is to investigate the correlation frequency of IL-38 positive cells per macrophage or monocytes in induced sputum and airway inflammation, hyperresponsiveness on methacholine, and asthmatic response after allergen challenge in atopic mild adult asthmatics.
Key secondary outcomes Secondary endpoint is investigate the correlation frequency of IL-38 positive cells per macrophage or monocytes in induced sputum and peripheral blood in atopic mild adult asthmatics. We investigate whether frequency of IL-38 positive cells per macrophage or monocytes induced sputum and peripheral blood will be able to usefulness to evaluate the pathogenesis and severity of asthma as a biomarker.

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. mild asthmatics and healthy non-smoking controls
2. Non-smokers
3. Stable for at least 4wks
4. %forced vital capacity >80% predicted, %forced expiratory volume in 1 sec, >80% predicted and a ratio FEV1/FVC >0.7
Key exclusion criteria 1. Difficulty expectoration of induced sputum
2. Presence of any other moderate and severe comorbidities
3. Current or ex-smokers
4. participants who have judged that research directors and researchers are inappropriate as research subjects
5. Nursing and pregnancy
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Tomotaka
Middle name
Last name Kawayama
Organization Kurume University
Division name Department of medicine
Zip code 830-0011
Address 67 Asahimachi, Kurume
TEL 0942-31-7560
Email kawayama_tomotaka@med.kurume-u.ac.jp

Public contact
Name of contact person
1st name Tomotaka
Middle name
Last name Kawayama
Organization Kurume University
Division name Department of medicine
Zip code 830-0011
Address 67 Asahimachi, Kurume
TEL 0942-31-7560
Homepage URL
Email kawayama_tomotaka@med.kurume-u.ac.jp

Sponsor
Institute Department of medicine, Kurume University
Institute
Department

Funding Source
Organization Department of medicine, Kurume 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 Kurume University
Address 67 Asahimachi, Kurume
Tel 0942-35-3311
Email sangakuml@kurume-u.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
2018 Year 08 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 Open public recruiting
Date of protocol fixation
2018 Year 07 Month 31 Day
Date of IRB
2018 Year 07 Month 18 Day
Anticipated trial start date
2018 Year 08 Month 01 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Cross-sectional study

Management information
Registered date
2018 Year 07 Month 17 Day
Last modified on
2019 Year 07 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038106

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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