UMIN-CTR Clinical Trial

Basic information
Public title	Analysis of airway and systemic effects of Heated tobacco products
Acronym	Analysis of airway and systemic effects of Heated tobacco products
Scientific Title	Analysis of airway and systemic effects of Heated tobacco products
Scientific Title:Acronym	Analysis of airway and systemic effects of Heated tobscco products
Region	Japan

Condition
Condition	Healthy subjects
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the airway effects of heated tobacco products
Basic objectives2	Others
Basic objectives -Others	To investigate the airway effects of heated tobacco products
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	airway and systemic inflammatory response
Key secondary outcomes

Base
Study type	Observational

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	more than 1 pack/day with(1)heated tobacco products and (2)cigarette smoke, or (3)non-smokers
Key exclusion criteria	lung diseases and chronic systemic diseases
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Shonosuke Middle name Last name Tajima
Organization	Kawasaki Medical School
Division name	Respiratory Medicine
Zip code	701-0162
Address	577 matsushima, Kurashiki city
TEL	086-462-1111
Email	shonosuke@med.kawasaki-m.ac.jp

Public contact
Name of contact person	1st name Shonosuke Middle name Last name Tajima
Organization	Kawasaki Medical School
Division name	Respiratory Medicine
Zip code	701-0162
Address	577 matsushima, Kurashiki city
TEL	086-462-1111
Homepage URL
Email	shonosuke@med.kawasaki-m.ac.jp

Sponsor
Institute	Kawasaki Medical School
Institute
Department

Funding Source
Organization	None
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	Kawasaki Medical School ethics committee
Address	577 matsushima, Kurashiki city
Tel	086-464-1076
Email	kmsrec@med.kawasaki-m.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	2019 Year 05 Month 18 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	No longer recruiting
Date of protocol fixation	2019 Year 05 Month 13 Day
Date of IRB	2019 Year 08 Month 16 Day
Anticipated trial start date	2019 Year 07 Month 15 Day
Last follow-up date	2021 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	If the subject is consented by a healthy volunteer, the subject will perform induction sputum, urine, blood, lung function test and exhaled breath NO test. The recruitment period is when 60 cases of the planned number of cases are gathered.

Management information
Registered date	2019 Year 05 Month 17 Day
Last modified on	2021 Year 09 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041850