Environmental ExposureNCT03550989

Real-Life Passive Exposure Assessment of IQOS

An observational study of Environmental Exposure, run by Philip Morris Products S.A. at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 20 years and olderHealthy volunteers can take part
Conditions the study is for: Environmental Exposure
What is being tested?: Non-Exposure Event and Exposure Event
How many people: 401 participants
Where: 1 siteJapan
Study dates: 5 Dec 2017to 16 May 2018
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: Female or male Japanese IQOS Users, Cigarette smokers, or Non-Smokers.

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Japan1 site

Angepatio Restaurant
Shibuya-ku, Tokyo, 150-0036

Other trials in Japan

About this study

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.

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.

Read the 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.

Conditions: Environmental Exposure
Being tested: Non-Exposure Event, Exposure Event
Keywords: Environmental Aerosol Exposure, Environmental Tobacco Smoke, Indoor Air Quality

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Non-Exposure EventOther
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 EventOther
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).

Study groups in NCT03550989
Study group	Role	What they receive
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.). Receives: Other: Non-Exposure Event; Other: Exposure Event
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) Receives: Other: Non-Exposure Event; Other: Exposure Event
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.) Receives: Other: Non-Exposure Event; Other: Exposure Event
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.) Receives: Other: Exposure Event

What is being measured

The primary outcome is the main question the study is designed to answer.

NEQ: (Non-Exposure Event)
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).
Measured: 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).
NEQ: (Exposure Event)
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.
Measured: 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).
Total NNAL: (Non-Exposure Event)
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).
Measured: 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).
Total NNAL: (Exposure Event)
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.
Measured: 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).
Total NNN: (Non-Exposure Event)
To measure Total N-nitrosonornicotine (Total NNN, a BoExp to Tobacco Specific Nitrosamines) in spot urine (expressed as concentration adjusted to creatinine).
Measured: 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).
Total NNN: (Exposure Event)
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.
Measured: 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 (18)

HPMA (Non-Exposure Events)
To measure 3-hydroxy-1-methylpropylmercapturic acid (HMPMA, a BoExp to Crotonaldehyde ) in spot urine (concentration adjusted for creatinine).
Measured: 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).
HPMA (Exposure Events)
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.
Measured: 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).
3-HPMA (Non-Exposure Events)
To measure 3 hydroxypropylmercapturic acid (3-HPMA, a BoExp to Acrolein) in spot urine (concentration adjusted for creatinine).
Measured: 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).
3-HPMA (Exposure Events)
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.
Measured: 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).
S-PMA (Non-Exposure Events)
To measure S-phenylmercapturic acid (S-PMA, a BoExp to Benzene) in spot urine (concentration adjusted for creatinine).
Measured: 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).
S-PMA (Exposure Events)
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.
Measured: 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).
HEMA (Non-Exposure Events)
To measure 2-hydroxyethyl mercapturic acid (HEMA, a BoExp to Ethylene Oxide) in spot urine (concentration adjusted for creatinine).
Measured: 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).
HEMA (Exposure Events)
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.
Measured: 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).
3-Ethenylpyridine (3-EP) [µg/m^3]
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.
Measured: 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.
Nicotine [µg/m^3]
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)
Measured: 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.
Acetaldehyde [µg/m^3]
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)
Measured: 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.
Acrolein [µg/m^3]
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)
Measured: 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.
Crotonaldehyde [µg/m^3]
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)
Measured: 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.
Formaldehyde [µg/m^3]
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)
Measured: 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.
NNN [µg/m^3]
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.
Measured: 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.
NNK [µg/m^3]
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.
Measured: 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.
PM1 Particles [µg/m^3]
Real-time measurements of PM1 suspended particles in air. (ISO Norm 18144:2003)
Measured: 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.
PM2.5 Particles [µg/m^3]
Real-time measurements of PM2.5 suspended particles in air. (ISO Norm 18144:2003)
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Dec 201716 May 2018

First posted11 Jun 2018
Study start5 Dec 2017
Primary completion30 Apr 2018
Study completion16 May 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Environmental ExposureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Other
Enrolment: 401 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03550989
Sponsor's protocol ID: P1-PES-01-JP
Status last verified: Aug 2019
First submitted: 20 Mar 2018
Last updated: 28 Aug 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT03550989
Acronym / sponsor ID: P1-PES-01-JP
Conditions: Environmental Exposure
Keywords: Environmental Aerosol Exposure, Environmental Tobacco Smoke, Indoor Air Quality
Study type: Observational
Recruitment status: Completed
Enrolment: 401 participants (actual)
Lead sponsor: Philip Morris Products S.A.Industry (pharma, biotech, devices)
Study start: 5 Dec 2017 (actual)
Primary completion: 30 Apr 2018 (actual)
Study completion: 16 May 2018 (actual)
First posted: 11 Jun 2018 (actual)
Results: Posted 29 Jul 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Other
Time perspective: Other
Number of arms: 4

Arm	Type	Receives
Non-Smokers	–	Other: Non-Exposure Event, Other: Exposure EventEach 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.).
Cigarette Smokers	–	Other: Non-Exposure Event, Other: Exposure EventEach 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)	–	Other: Non-Exposure Event, Other: Exposure EventEach 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.)
IQOS Active Users (using IQOS)	–	Other: Exposure EventEach 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.)

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Female or male Japanese IQOS Users, Cigarette smokers, or Non-Smokers.

Key inclusion criteria (5 listed)

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

Key exclusion criteria (7 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Non-Exposure EventNon-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	Cigarette Smokers, IQOS Passive Users (not using IQOS), Non-Smokers
Exposure EventExposure 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).	Other	Cigarette Smokers, IQOS Active Users (using IQOS), IQOS Passive Users (not using IQOS), Non-Smokers

Primary outcome

NEQ: (Non-Exposure Event)
Time frame: 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).
NEQ: (Exposure Event)
Time frame: 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)
Time frame: 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).
Total NNAL: (Exposure Event)
Time frame: 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: (Non-Exposure Event)
Time frame: 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).
Total NNN: (Exposure Event)
Time frame: 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.

18 secondary outcomes

HPMA (Non-Exposure Events)
Time frame: 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).
HPMA (Exposure Events)
Time frame: 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).
3-HPMA (Non-Exposure Events)
Time frame: 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).
3-HPMA (Exposure Events)
Time frame: 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).
S-PMA (Non-Exposure Events)
Time frame: 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).
S-PMA (Exposure Events)
Time frame: 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).
HEMA (Non-Exposure Events)
Time frame: 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).
HEMA (Exposure Events)
Time frame: 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).
3-Ethenylpyridine (3-EP) [µg/m^3]
Time frame: 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.
Nicotine [µg/m^3]
Time frame: 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.
Acetaldehyde [µg/m^3]
Time frame: 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.
Acrolein [µg/m^3]
Time frame: 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.
Crotonaldehyde [µg/m^3]
Time frame: 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.
Formaldehyde [µg/m^3]
Time frame: 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.
NNN [µg/m^3]
Time frame: 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.
NNK [µg/m^3]
Time frame: 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.
PM1 Particles [µg/m^3]
Time frame: 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.
PM2.5 Particles [µg/m^3]
Time frame: 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.

Results and safety

Results posted to the registry on 29 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Non-Smokers	190	188
Cigarette Smokers	74	73
IQOS Passive Users (Not Using IQOS)	77	76
IQOS Active Users (Using IQOS)	60	60

Primary outcome: NEQ: (Non-Exposure Event)

Time frame: 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).. Geometric mean (95% Confidence Interval). Unit: mg/g

Measure	Non-Smokers n = 77	Cigarette Smokers n = 32	IQOS Passive Users (Not Using IQOS) n = 32
Baseline	0.03845 (0.03120 to 0.04739)	4.159 (2.253 to 7.678)	5.695 (4.286 to 7.567)
Final void	0.06876 (0.05527 to 0.08553)	5.175 (2.902 to 9.228)	6.821 (5.127 to 9.074)

Population analysed: Some participants were excluded from analysis for protocol deviations (including but not limited to, missing questionnaires, attended events but was not eligible to attend, assigned to an incorrect group, or missing samples).

Primary outcome: NEQ: (Exposure Event)

Measure	Non-Smokers n = 113	Cigarette Smokers n = 42	IQOS Passive Users (Not Using IQOS) n = 45	IQOS Active Users (Using IQOS) n = 60
Baseline	0.04078 (0.03397 to 0.04896)	3.051 (1.720 to 5.414)	5.277 (4.018 to 6.930)	4.683 (3.553 to 6.171)
Final void	0.06205 (0.05000 to 0.07700)	2.889 (1.573 to 5.308)	5.974 (4.696 to 7.598)	8.499 (6.667 to 10.83)

Primary outcome: Total NNAL: (Non-Exposure Event)

Measure	Non-Smokers n = 77	Cigarette Smokers n = 32	IQOS Passive Users (Not Using IQOS) n = 32
Baseline	NA (NA to NA)	69.65 (46.62 to 104.0)	20.55 (13.91 to 30.36)
Final Void	NA (NA to NA)	81.64 (59.48 to 112.1)	27.41 (18.88 to 39.80)

Primary outcome: Total NNAL: (Exposure Event)

Measure	Non-Smokers n = 113	Cigarette Smokers n = 42	IQOS Passive Users (Not Using IQOS) n = 45	IQOS Active Users (Using IQOS) n = 60
Baseline	NA (NA to NA)	48.57 (34.57 to 68.25)	19.68 (15.78 to 24.56)	21.50 (16.29 to 28.38)
Final Void	NA (NA to NA)	58.74 (45.76 to 75.39)	20.31 (15.83 to 26.06)	30.45 (23.91 to 38.77)

18 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from the signature of the ICF by each subject until the end of the study, for a duration of up to 6 weeks for each subject.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Non-Smokers	0 of 190 (0%)	0 of 190 (0%)	0 of 190
Cigarette Smokers	0 of 74 (0%)	0 of 74 (0%)	0 of 74
IQOS Passive Users (Not Using IQOS)	0 of 77 (0%)	0 of 77 (0%)	0 of 77
IQOS Active Users (Using IQOS)	0 of 60 (0%)	0 of 60 (0%)	0 of 60

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Patrick Picavet, MD study chair

Philip Morris Products S.A.

Takao Ohki, MD, PhD principal investigator

Jikei University School of Medicine, Tokyo

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Environmental Exposure, run by Philip Morris Products S.A. at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

NEQ: (Non-Exposure Event) (time frame: 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).). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03550989.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.