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Real-Life Passive Exposure Assessment of IQOS | Clinical Trials | Clareo Health

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Real-Life Passive Exposure Assessment of IQOS

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.

NCT03550989•Philip Morris Products S.A.

View on ClinicalTrials.gov

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.

Eligibility

Age

20 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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.

Locations (1)

Angepatio Restaurant

Shibuya-ku, Tokyo, Japan

Key Dates

Start Date

December 5, 2017

Primary Completion Date

April 30, 2018

Completion Date

May 16, 2018

Last Updated

August 28, 2019

Enrollment

401

ACTUAL participants

Conditions

Environmental Exposure

Interventions

Non-Exposure Event

OTHER

Exposure Event

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 28, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Real-Life Passive Exposure Assessment of IQOS

Inclusion Criteria

Exclusion Criteria

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