UMIN-CTR Clinical Trial

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
Email	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
Email	yuki0301@saitama-med.ac.jp

Sponsor
Institute	Saitama Medical University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056096