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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036782
Receipt No. R000041850
Scientific Title Analysis of airway and systemic effects of Heated tobacco products
Date of disclosure of the study information 2019/05/18
Last modified on 2019/05/17

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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 Yasokawa
Middle name
Last name Naoya
Organization Kawasaki Medical School
Division name Respiratory Medicine
Zip code 701-0162
Address 577 matsushima, Kurashiki city
TEL 086-462-1111
Email naoya.y@med.kawasaki-m.ac.jp

Public contact
Name of contact person
1st name Yasokawa
Middle name
Last name Naoya
Organization Kawasaki Medical School
Division name Respiratory Medicine
Zip code 701-0162
Address 577 matsushima, Kurashiki city
TEL 086-462-1111
Homepage URL
Email naoya.y@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 Preinitiation
Date of protocol fixation
2019 Year 05 Month 13 Day
Date of IRB
Anticipated trial start date
2019 Year 07 Month 15 Day
Last follow-up date
2021 Year 03 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
2019 Year 05 Month 17 Day


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

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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