Clinical trial NCT03550989: Real-Life Passive Exposure Assessment of IQOS
Official title: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Environmental Exposure
Keywords: Environmental Aerosol Exposure
Environmental Tobacco Smoke
Indoor Air Quality
Lead sponsor: Philip Morris Products S.A.
Sponsor class: INDUSTRY
First posted: 2018-06-11
Enrollment: 401
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female or male Japanese IQOS Users, Cigarette smokers, or Non-Smokers.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: NEQ: (Non-Exposure Event)
timeFrame: 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).
measure: NEQ: (Exposure Event)
timeFrame: 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).
measure: Total NNAL: (Non-Exposure Event)
timeFrame: 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).
measure: Total NNAL: (Exposure Event)
timeFrame: 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).
measure: Total NNN: (Non-Exposure Event)
timeFrame: 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).
measure: Total NNN: (Exposure Event)
timeFrame: 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).
Secondary outcomes:
measure: HPMA (Non-Exposure Events)
timeFrame: 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).
measure: HPMA (Exposure Events)
timeFrame: 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).
measure: 3-HPMA (Non-Exposure Events)
timeFrame: 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).
measure: 3-HPMA (Exposure Events)
timeFrame: 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).
measure: S-PMA (Non-Exposure Events)
timeFrame: 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).
measure: S-PMA (Exposure Events)
timeFrame: 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).
measure: HEMA (Non-Exposure Events)
timeFrame: 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).
measure: HEMA (Exposure Events)
timeFrame: 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).
measure: 3-Ethenylpyridine (3-EP) [µg/m^3]
timeFrame: 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.
measure: Nicotine [µg/m^3]
timeFrame: 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.
measure: Acetaldehyde [µg/m^3]
timeFrame: 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.
measure: Acrolein [µg/m^3]
timeFrame: 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.
measure: Crotonaldehyde [µg/m^3]
timeFrame: 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.
measure: Formaldehyde [µg/m^3]
timeFrame: 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.
measure: NNN [µg/m^3]
timeFrame: 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.
measure: NNK [µg/m^3]
timeFrame: 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.
measure: PM1 Particles [µg/m^3]
timeFrame: 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.
measure: PM2.5 Particles [µg/m^3]
timeFrame: 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.
Other outcomes:
Locations:
city: Shibuya-ku
country: Japan
facility: Angepatio Restaurant
state: Tokyo
Study officials:
affiliation: Philip Morris Products S.A.
name: Patrick Picavet, MD
role: STUDY_CHAIR
affiliation: Jikei University School of Medicine, Tokyo
name: Takao Ohki, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: