UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036304 |
|---|---|
| Receipt number | R000041366 |
| Scientific Title | An Observational Study in Japan to Investigate Health Outcomes Associated With the Use of Ploom TECH |
| Date of disclosure of the study information | 2020/03/26 |
| Last modified on | 2023/02/15 11:11:49 |
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Basic information
Public title
An Observational Study in Japan to Investigate Health Outcomes Associated With the Use of Ploom TECH
Acronym
Cross-Sectional Survey in Japan
Scientific Title
An Observational Study in Japan to Investigate Health Outcomes Associated With the Use of Ploom TECH
Scientific Title:Acronym
Cross-Sectional Survey in Japan
Region
| Japan |
Condition
Condition
Tobacco Product Users and Non-smokers
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
-To investigate biomarkers of exposure to selected smoke constituents and potential harm relative to smoking in Ploom TECH users, cigarette smokers and non-smokers
-To investigate health condition in Ploom TECH users, cigarette smokers and no- smokers
-To investigate health related QOL in Ploom TECH users, cigarette smokers and non-smokers
-To invetigate level of cough in Ploom TECH users, cigarette smokers and non-smokers
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
-Biomarkers of exposure to selected smoke constituents and potential harm relative to smoking
-Health condition
-Health related QOL
-Level of cough
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
| 21 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
-Subjects who sign the study-specific consent form
-Ploom TECH user: Subjects who use Ploom TECH exclusively more than three months
-Cigarette smoker: Subjects who smoke cigarettes exclusively more than one year
-Non-smoker: Subjects who have never used tobacco products and nicotine containing products
etc.
Key exclusion criteria
-Subjects who have, or who have a history of, any clinically significant cardiovascular, hepatic, renal, hematological, respiratory, endocrine, metabolic, electrolyte imbalance
-Subjects who have received any investigational drug within 4 months prior to the study period
-Pregnant or lactating women or women who may be pregnant
-Tobacco industry employees
-Employed by the Sponsor, CRO or Clinical Site
etc.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Ishikawa |
Organization
JAPAN TOBACCO INC.
Division name
Scientific and Regulatoly Affairs, Tobacco Business Headquarters
Zip code
105-8822
Address
2-2-1, Toranomon, Minato-ku, Tokyo
TEL
03-5572-4218
satoshi.ishikawa@jt.com
Public contact
Name of contact person
| 1st name | Chikako |
| Middle name | |
| Last name | Sakaguchi |
Organization
JAPAN TOBACCO INC.
Division name
Scientific Regulatoly Affairs, Tobacco Business Headquarters
Zip code
105-8822
Address
2-2-1, Toranomon, Minato-ku, Tokyo
TEL
03-5572-4819
Homepage URL
chikako.sakaguchi@jt.com
Sponsor or person
Institute
JAPAN TOBACCO INC.
Institute
Department
Personal name
Funding Source
Organization
JAPAN TOBACCO INC.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Mediacl Corporation Shinanokai Shinanozaka Clinic IRB
Address
20, Samonn-cho, Shinjyuku-ku, Tokyo
Tel
03-5366-3006
h-ogura@trcp.co.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
| 2020 | Year | 03 | Month | 26 | Day |
Related information
URL releasing protocol
Unpublished
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/33502518/
Number of participants that the trial has enrolled
459
Results
In a post-marketing study under actual use conditions,BoPH(HDL-C, TG, sICAM-1, WBC count, 11-DHTXB2, 2,3-d-TXB2, 8-epi-PGF2a, FEV1, %FEV1 and FEF25-75) associated with smoking-related disease examined in exclusive Ploom TECH users were found to be favorably different from those of conventional cigarette (CC) smokers. Moreover, the levels of BoPH(HDL-C, TG, sICAM-1, WBC count, 11-DHTXB2, 8-epi-PGF2a, and FEF25-75) in the Ploom TECH group were comparable to those in the never-smokers (NS) group.
Results date posted
| 2023 | Year | 02 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Regarding subject background information, the percentage composition by gender, age, and BMI in the Ploom TECH, CC, and NS groups were comparable. The average of age and BMI were 45.4 (range: 21-64) years and 23.95 (range: 14.4-40.7) kg/m2, respectively. There were no differences between groups in terms of sex, age, and BMI.
Participant flow
Informed consent was obtained from 568 participants (Ploom TECH group: 301, CC group: 134, NS group 133; of which 109 participants did not meet the protocol inclusion/exclusion criteria. The remaining 459 participants (Ploom TECH group: 259, CC group: 100, NS group 100) were enrolled into the study, and all enrolled subjects completed the study.
Adverse events
Not applicable
Outcome measures
Biomarkers of exposure to selected smoke constituents, and BoPH relative to smoking related disease.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 03 | Month | 26 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 06 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cross-Sectional Survey in Japan
Management information
Registered date
| 2019 | Year | 03 | Month | 27 | Day |
Last modified on
| 2023 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041366
