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Real-Life Passive Exposure Assessment of IQOS

NCT03550989 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 401

Last updated 2019-08-28

Study results available
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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.

Conditions

  • Environmental Exposure

Interventions

OTHER

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.

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).

Sponsors & Collaborators

  • Philip Morris Products S.A.

    lead INDUSTRY

Principal Investigators

  • Patrick Picavet, MD · Philip Morris Products S.A.

  • Takao Ohki, MD, PhD · Jikei University School of Medicine, Tokyo

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-12-05
Primary Completion
2018-04-30
Completion
2018-05-16

Countries

  • Japan

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03550989 on ClinicalTrials.gov