UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033420 |
|---|---|
| Receipt number | 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 | 2025/01/20 12:57:19 |
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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
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
kawayama_tomotaka@med.kurume-u.ac.jp
Sponsor or person
Institute
Department of medicine, Kurume University
Institute
Department
Personal name
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
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
52
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
Terminated
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
| 2024 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2025 | Year | 01 | Month | 17 | Day |
Other
Other related information
Cross-sectional study
Management information
Registered date
| 2018 | Year | 07 | Month | 17 | Day |
Last modified on
| 2025 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038106
