Real-Life Passive Exposure Assessment of IQOS

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

401 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-05

Study Completion Date

2018-05-16

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Environmental Exposure

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Non-Smokers

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.).

Non-Exposure Event

Intervention Type OTHER

Non-Exposure event of 4h duration for the individual participants, where no use of any tobacco or nicotine-containing product is allowed, designed to establish background measurements in the absence of exposure to IQOS.

Exposure Event

Intervention Type OTHER

Exposure Event designed to measure urinary BoExp to selected HPHCs representative of ETS in all participant groups, with up to 5h of exposure to IQOS tobacco environmental aerosol for non-smokers, cigarette smokers (not using any tobacco or nicotine-containing product, including cigarettes), and IQOS passive users (not using IQOS). Additionally, this event includes up to 8h of exposure for IQOS active users (using IQOS).

Cigarette Smokers

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)

Non-Exposure Event

Intervention Type OTHER

Non-Exposure event of 4h duration for the individual participants, where no use of any tobacco or nicotine-containing product is allowed, designed to establish background measurements in the absence of exposure to IQOS.

Exposure Event

Intervention Type OTHER

Exposure Event designed to measure urinary BoExp to selected HPHCs representative of ETS in all participant groups, with up to 5h of exposure to IQOS tobacco environmental aerosol for non-smokers, cigarette smokers (not using any tobacco or nicotine-containing product, including cigarettes), and IQOS passive users (not using IQOS). Additionally, this event includes up to 8h of exposure for IQOS active users (using IQOS).

IQOS Passive Users (not using IQOS)

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-Exposure Event

Intervention Type OTHER

Non-Exposure event of 4h duration for the individual participants, where no use of any tobacco or nicotine-containing product is allowed, designed to establish background measurements in the absence of exposure to IQOS.

Exposure Event

Intervention Type OTHER

Exposure Event designed to measure urinary BoExp to selected HPHCs representative of ETS in all participant groups, with up to 5h of exposure to IQOS tobacco environmental aerosol for non-smokers, cigarette smokers (not using any tobacco or nicotine-containing product, including cigarettes), and IQOS passive users (not using IQOS). Additionally, this event includes up to 8h of exposure for IQOS active users (using IQOS).

IQOS Active Users (using IQOS)

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.)

Exposure Event

Intervention Type OTHER

Exposure Event designed to measure urinary BoExp to selected HPHCs representative of ETS in all participant groups, with up to 5h of exposure to IQOS tobacco environmental aerosol for non-smokers, cigarette smokers (not using any tobacco or nicotine-containing product, including cigarettes), and IQOS passive users (not using IQOS). Additionally, this event includes up to 8h of exposure for IQOS active users (using IQOS).

Interventions

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Non-Exposure Event

Non-Exposure event of 4h duration for the individual participants, where no use of any tobacco or nicotine-containing product is allowed, designed to establish background measurements in the absence of exposure to IQOS.

Intervention Type OTHER

Exposure Event

Exposure Event designed to measure urinary BoExp to selected HPHCs representative of ETS in all participant groups, with up to 5h of exposure to IQOS tobacco environmental aerosol for non-smokers, cigarette smokers (not using any tobacco or nicotine-containing product, including cigarettes), and IQOS passive users (not using IQOS). Additionally, this event includes up to 8h of exposure for IQOS active users (using IQOS).

Intervention Type OTHER

Eligibility Criteria

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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).

* 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.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes