Environmental Exposure Clinical Trial
Official title:
Assessment of Passive Environmental Aerosol Exposure Through IQOS (Tobacco Heating System [THS] With Marlboro Heatsticks) in a Restaurant Setting Where IQOS Use, But Not Cigarette Smoking, is Allowed.
This study is a non-interventional observational study designed to assess the impact of passive exposure to IQOS environmental tobacco aerosol in Non-Smokers in a real-life restaurant setting.
The purpose of the study is to show that Non-Smokers, exposed to environmental tobacco
aerosol from IQOS in a restaurant setting, do not have higher urinary levels of Biomarkers of
Exposure (BoExp) to selected Harmful and Potentially Harmful Constituents (HPHCs),
representative of Environmental Tobacco Smoke (ETS), compared to the urinary levels of BoExp
measured in Non-Smokers before IQOS environmental tobacco aerosol exposure.
Furthermore, the impact of passive exposure to IQOS environmental tobacco aerosol on IQOS
Users and Cigarette Smokers, not using any tobacco or nicotine-containing products, will be
investigated. This will enable the assessment of individuals with varying levels of exposure
to HPHCs and determine whether there is any measurable additional exposure related to the
environmental tobacco aerosol from IQOS.
The study will also evaluate Indoor Air Quality (IAQ) through the assessment of
concentrations of nicotine and selected HPHCs representative of tobacco-specific and IAQ
markers in the air during exposure and non-exposure periods in a real-life restaurant
setting.
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