An Observational Study in Japan to Investigate Health Outcomes Associated With the Use of Ploom TECH
- Conditions
- Tobacco Product Users and Non-smokers
- Registration Number
- JPRN-UMIN000036304
- Lead Sponsor
- JAPAN TOBACCO INC.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 459
Not provided
-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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method -Biomarkers of exposure to selected smoke constituents and potential harm relative to smoking -Health condition -Health related QOL -Level of cough
- Secondary Outcome Measures
Name Time Method