Real-Life Passive Exposure Assessment of IQOS

Completed

Conditions: Environmental Exposure

Interventions: Other: Non-Exposure Event
Other: Exposure Event

Registration Number: NCT03550989

Lead Sponsor: Philip Morris Products S.A.

Brief Summary: 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.

Detailed 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 401

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.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cigarette Smokers	Non-Exposure Event	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)
IQOS Passive Users (not using IQOS)	Non-Exposure Event	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.)
Non-Smokers	Non-Exposure Event	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.).
IQOS Passive Users (not using IQOS)	Exposure Event	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.)
Cigarette Smokers	Exposure Event	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)
IQOS Active Users (using IQOS)	Exposure Event	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.)
Non-Smokers	Exposure Event	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.).

Primary Outcome Measures

Name	Time	Method
NEQ: (Non-Exposure Event)	Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).	To measure nicotine equivalents (NEQ, a biomarker of exposure to Nicotine): molar sum of free nicotine, nicotine-glucuronide, free cotinine, cotinine-glucuronide, free trans-3'-hydroxycotinine, trans-3'-hydroxycotinine-glucuronide in spot urine (expressed as concentration adjusted to creatinine).
Total NNAL: (Exposure Event)	Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).	To measure Total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL, a BoExp to Tobacco Specific Nitrosamines) in spot urine (expressed as concentration adjusted to creatinine), during exposure events where some subjects used IQOS.
Total NNN: (Exposure Event)	Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).	To measure Total N-nitrosonornicotine (Total NNN, a BoExp to Tobacco Specific Nitrosamines) in spot urine (expressed as concentration adjusted to creatinine) during exposure events where some subjects used IQOS.
Total NNN: (Non-Exposure Event)	Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).	To measure Total N-nitrosonornicotine (Total NNN, a BoExp to Tobacco Specific Nitrosamines) in spot urine (expressed as concentration adjusted to creatinine).
NEQ: (Exposure Event)	Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).	To measure nicotine equivalents (NEQ, a biomarker of exposure to Nicotine): molar sum of free nicotine, nicotine-glucuronide, free cotinine, cotinine-glucuronide, free trans-3'-hydroxycotinine, trans-3'-hydroxycotinine-glucuronide in spot urine (expressed as concentration adjusted to creatinine), during exposure events where some subjects used IQOS.
Total NNAL: (Non-Exposure Event)	Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).	To measure Total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL, a BoExp to Tobacco Specific Nitrosamines) in spot urine (expressed as concentration adjusted to creatinine).

Secondary Outcome Measures

Name	Time	Method
HPMA (Exposure Events)	Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).	To measure 3-hydroxy-1-methylpropylmercapturic acid (HMPMA, a BoExp to Crotonaldehyde ) in spot urine (concentration adjusted for creatinine), during exposure events where some subjects used IQOS.
Formaldehyde [µg/m^3]	Measured at baseline for up to 3h prior to start of the event, then continuously during the event until 3h after the last participant has entered the event for 1h.	To measure IAQ, in real-time, through the assessment of concentrations of nicotine and select HPHCs representative of ETS in the air of the study site. (ISO Norm 18144:2003)
HPMA (Non-Exposure Events)	Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).	To measure 3-hydroxy-1-methylpropylmercapturic acid (HMPMA, a BoExp to Crotonaldehyde ) in spot urine (concentration adjusted for creatinine).
3-HPMA (Exposure Events)	Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).	To measure 3 hydroxypropylmercapturic acid (3-HPMA, a BoExp to Acrolein) in spot urine (concentration adjusted for creatinine), during exposure events where some subjects used IQOS.
S-PMA (Non-Exposure Events)	Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).	To measure S-phenylmercapturic acid (S-PMA, a BoExp to Benzene) in spot urine (concentration adjusted for creatinine).
S-PMA (Exposure Events)	Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).	To measure S-phenylmercapturic acid (S-PMA, a BoExp to Benzene ) in spot urine (concentration adjusted for creatinine), during exposure events where some subjects used IQOS.
NNN [µg/m^3]	Measured at baseline for up to 3h prior to start of the event, then continuously during the event until 3h after the last participant has entered the event for 1h.	To measure IAQ, in real-time, through the assessment of concentrations of nicotine and select HPHCs representative of ETS in the air of the study site. (ISO Norm 18144:2003) Note that the measurements were below the limit of detection.
Nicotine [µg/m^3]	Measured at baseline for up to 3h prior to start of the event, then continuously during the event until 3h after the last participant has entered the event for 1h.	To measure IAQ, in real-time, through the assessment of concentrations of nicotine and select HPHCs representative of ETS in the air of the study site. (ISO Norm 18144:2003)
PM1 Particles [µg/m^3]	Measured at baseline for up to 3h prior to start of the event, then continuously during the event until 3h after the last participant has entered the event for 1h.	Real-time measurements of PM1 suspended particles in air. (ISO Norm 18144:2003)
PM2.5 Particles [µg/m^3]	Measured at baseline for up to 3h prior to start of the event, then continuously during the event until 3h after the last participant has entered the event for 1h.	Real-time measurements of PM2.5 suspended particles in air. (ISO Norm 18144:2003)
3-HPMA (Non-Exposure Events)	Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).	To measure 3 hydroxypropylmercapturic acid (3-HPMA, a BoExp to Acrolein) in spot urine (concentration adjusted for creatinine).
Acetaldehyde [µg/m^3]	Measured at baseline for up to 3h prior to start of the event, then continuously during the event until 3h after the last participant has entered the event for 1h.	To measure IAQ, in real-time, through the assessment of concentrations of nicotine and select HPHCs representative of ETS in the air of the study site. (ISO Norm 18144:2003)
HEMA (Non-Exposure Events)	Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).	To measure 2-hydroxyethyl mercapturic acid (HEMA, a BoExp to Ethylene Oxide) in spot urine (concentration adjusted for creatinine).
HEMA (Exposure Events)	Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).	To measure 2-hydroxyethyl mercapturic acid (HEMA, a BoExp to Ethylene Oxide) in spot urine (concentration adjusted for creatinine), during exposure events where some subjects used IQOS.
3-Ethenylpyridine (3-EP) [µg/m^3]	Measured at baseline for up to 3h prior to start of the event, then continuously during the event until 3h after the last participant has entered the event for 1h.	To measure IAQ, in real-time, through the assessment of concentrations of nicotine and select HPHCs representative of ETS in the air of the study site. (ISO Norm 18144:2003) Note that the measurements of 3-EP \[µg/m\^3\] were below the limit of detection.
Acrolein [µg/m^3]	Measured at baseline for up to 3h prior to start of the event, then continuously during the event until 3h after the last participant has entered the event for 1h.	To measure IAQ, in real-time, through the assessment of concentrations of nicotine and select HPHCs representative of ETS in the air of the study site. (ISO Norm 18144:2003)
Crotonaldehyde [µg/m^3]	Measured at baseline for up to 3h prior to start of the event, then continuously during the event until 3h after the last participant has entered the event for 1h.	To measure IAQ, in real-time, through the assessment of concentrations of nicotine and select HPHCs representative of ETS in the air of the study site. (ISO Norm 18144:2003)
NNK [µg/m^3]	Measured at baseline for up to 3h prior to start of the event, then continuously during the event until 3h after the last participant has entered the event for 1h.	To measure IAQ, in real-time, through the assessment of concentrations of nicotine and select HPHCs representative of ETS in the air of the study site. (ISO Norm 18144:2003) Note that the measurements of NNK \[µg/m3\] were below the limit of detection.