UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036782 |
|---|---|
| Receipt number | 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 | 2021/09/11 07:16:18 |
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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 | 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
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
shonosuke@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041850
