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More info
You can access this
clinical trial
if you have
Smoking or Tobacco Product
and you are
over 20
years old
-
This is an observational trial.
You are contributing to medical knowledge about your condition.
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The purpose

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.

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT03020667. The sponsor of the trial is Philip Morris Products S.A. and it is looking for 1124 volunteers for the current phase.
Official trial title:
An Observational Cohort Study in Japan to Assess the Patterns of Product Use and Changes in Health Status Associated With the Use of HeatSticks With the THS 2.2 Tobacco Heating System