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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name