UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049253 |
|---|---|
| Receipt number | R000056096 |
| Scientific Title | Clinical Investigation of IL-36 family in Blood and Sputum from Patients with Asthma |
| Date of disclosure of the study information | 2022/10/31 |
| Last modified on | 2022/10/18 16:13:40 |
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Basic information
Public title
Clinical Investigation of IL-36 family in Blood and Sputum from Patients with Asthma
Acronym
Clinical Investigation of IL-36 family in Blood and Sputum from Patients with Asthma
Scientific Title
Clinical Investigation of IL-36 family in Blood and Sputum from Patients with Asthma
Scientific Title:Acronym
Clinical Investigation of IL-36 family in Blood and Sputum from Patients with Asthma
Region
| Japan |
Condition
Condition
asthma /COPD
Classification by specialty
| Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Targeting bronchial asthma, COPD (chronic obstructive pulmonary disease), and healthy adults, measure IL-36 in sputum and blood of subjects, and stratify specificity based on phenotyping classification by severity and airway inflammation type To analyze.
Basic objectives2
Others
Basic objectives -Others
We will conduct a stratified analysis according to the presence or absence of acute exacerbation, the presence or absence of smoking, and the presence or absence of therapeutic intervention with inhaled steroids, and examine the clinical usefulness of IL-36 in sputum and blood.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stratified analysis based on disease specificity and phenotyping classification of sputum and blood IL-36 in bronchial asthma and COPD (chronic obstructive pulmonary disease).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Maneuver
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) Cases where expectoration of sputum is possible
2) SpO2 > 95% cases
3) Patients who can gargle
4) Cases that can be tested according to the instructions of the person in charge
5) Patients aged 20 years or older (COPD cases aged 40 years or older)
6)Patients who gave written informed consent to participate in this clinical trial.
Key exclusion criteria
1) Patients with severe respiratory failure
2) Healthy subjects with allergens
3) Patients with systemic allergic diseases such as allergic pulmonary aspergillosis and Churg Struss syndrome
4) Patients with the following serious complications
Heart disease, renal disease, digestive system disease, neurological disease, atopic dermatitis, respiratory failure
5) Pregnant women, lactating women, and those who may or intend to become pregnant
6) Other cases judged inappropriate by the investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Hoshino |
Organization
Saitama Medical University
Division name
Department of Respiratory Medicine
Zip code
3500495
Address
Morohonngou 38 Irumagun Saitama
TEL
0492761319
yuki0301@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Hoshino |
Organization
Saitama Medical University
Division name
Department of Respiratory Medicine
Zip code
3500495
Address
Morohonngou 38 Irumagun Saitama
TEL
0492761319
Homepage URL
yuki0301@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Medical University
Address
Morohonngou 38 Irumagun Saitama
Tel
0492761319
yuki0301@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
| 2022 | Year | 10 | Month | 31 | 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
| 2020 | Year | 03 | Month | 02 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 02 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 18 | Day |
Last modified on
| 2022 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056096
