Real-Life Passive Exposure Assessment of IQOS

Launched by PHILIP MORRIS PRODUCTS S.A. · May 25, 2018

Keywords

ClinConnect Summary

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...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Participant is able to understand the information provided in the Subject Information Sheet (SIS) and Informed Consent Form (ICF) (confirmed by signing the ICF) and has signed the ICF.
• • Adults legally authorized to buy tobacco products in Japan (20 years of age).
• • Participant is Japanese as self-reported.
• • Willing to participate in the study, comply with study procedures and has access to the Internet.
• • Participant is an active IQOS User, Cigarette smoker or Non-Smoker as self-reported
• Exclusion Criteria:
• • Participant with a medical history of severe cardiovascular or respiratory diseases (e.g., stroke, acute cardiovascular event, pulmonary thrombosis) in the last 12 months as self-reported.
• • Participant with currently active cancer or history of cancer within the last 5 years as self-reported.
• • Female participant who is pregnant or breast-feeding as self-reported.
• • Participant is a current or former employee of the tobacco industry or their first-degree relatives (parent and child).
• • Participant is an employee of Philip Morris International (PMI), an employee of the Contract Research Organization (CRO) engaged for this study, an employee of the CRO's vendors, an employee of the restaurant/event location, or their first-degree relatives (parent or child).
• Exclusion criteria specific to participants who are Non-Smokers:
• • Participant lives in a household with users of tobacco or nicotine-containing products, or is exposed to the use of tobacco or nicotine-containing products at the workplace.