The Tobacco Heating System (THS 2.2) which is commercialized under the iQOS brand name (as
described in the study protocol) in Japan is subject to an assessment program which includes
post-market studies such as the Japanese Post-Market Cohort Study.
The objectives and endpoints of this Post-Market Cohort Study will be analyzed in the study
population of adult tobacco users and never smokers in Japan. This includes:
- Provide a perspective of tobacco product use in a "real world setting", where
simultaneous use of tobacco and nicotine containing products may occur,
- Describe population-level changes in biomarkers of exposure (BoExp) following long
duration of CC and THS 2.2 use,
- Evaluate whether there is a difference in the levels of selected clinical risk endpoints
(CREs) between CC smokers and THS 2.2 users.
This study is divided in 2:
- Main Study: the Main Study will describe the patterns of use of tobacco and nicotine
containing products and self-reported health outcomes and health related events in CC
smokers and THS 2.2 users. THS 2.2 users and CC smokers will be identified and invited
for participation in the study until each annual wave of 500 participants for each
product is filled.
- Clinical Sub-Study: the Clinical Sub-Study will further assess the population level
differences in BoExp to harmful and potentially harmful constituents (HPHCs), CREs, and
self-reported symptoms and health outcomes between CC smokers, THS 2.2 users and
never-smokers, the latter group only included in the Clinical Sub-Study. THS 2.2 users
enrolled in the Main Study will be invited to enroll in the Clinical Sub-Study where
clinical assessments will be performed and biological samples (blood, serum, plasma, and
urine) will be collected. There will be two clinical study visits, which will take place
at Month 12 (Visit 1) and Month 36 post product initiation (Visit 2).
Participants will be recruited into the cohort in annual waves over a period of 4 years.