Real-Life Passive Exposure Assessment of IQOS

Philip Morris

Status: Completed

Conditions: Environmental Exposure

Treatments: Other: Exposure Event; Other: Non-Exposure Event

Study type: Observational

Funder types: Industry

Identifiers

NCT03550989

P1-PES-01-JP

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 401 patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

401 participants in 4 patient groups

Non-Smokers

Description:

Each participant can participate in one Non-Exposure Event and one Exposure Event only. * Abstinent for at least 12 months from the use of any nicotine and/or tobacco-containing product based on self-reporting. * Must not be exposed to tobacco or nicotine-containing products use in any other substantial way (family, partner, workplace, etc.).

Treatment:

Other: Exposure Event

Other: Non-Exposure Event

Cigarette Smokers

Description:

Each participant can participate in one Non-Exposure Event and one Exposure Event only. * Used at least 100 cigarettes * Smokes cigarettes daily \> 1/day * Uses IQOS less than daily * Uses less than 30 HeatSticks/month * Cigarette is \> 95% of tobacco/nicotine product (all product use)

Treatment:

Other: Exposure Event

Other: Non-Exposure Event

IQOS Passive Users (not using IQOS)

Description:

Each participant can participate in one Non-Exposure Event and one Exposure Event only. * Used at least 100 HeatSticks * Uses IQOS daily \> 1/day * Smokes a cigarette less than daily * Smokes less than 30 cigarettes/month * IQOS is \> 95% of tobacco/nicotine product (all product use) - excluding other products (e-cig/Ploom/etc.)

Treatment:

Other: Exposure Event

Other: Non-Exposure Event

IQOS Active Users (using IQOS)

Description:

Each participant can participate in one Exposure Event only. * Used at least 100 HeatSticks * Uses IQOS daily \> 1/day * Smokes a cigarette less than daily * Smokes less than 30 cigarettes/month * IQOS is \> 95% of tobacco/nicotine product (all product use) - excluding other products (e-cig/Ploom/etc.)

Treatment:

Other: Exposure Event