Environmental Exposure
Conditions
Keywords
Environmental Aerosol Exposure, Environmental Tobacco Smoke, Indoor Air Quality
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.
Interventions
OTHERNon-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.
OTHERExposure 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
Philip Morris Products S.A.
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NEQ: (Non-Exposure Event) | 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) | 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) | 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) | 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) | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| S-PMA (Non-Exposure Events) | 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 S-phenylmercapturic acid (S-PMA, a BoExp to Benzene) in spot urine (concentration adjusted for creatinine). |
| S-PMA (Exposure Events) | 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 S-phenylmercapturic acid (S-PMA, a BoExp to Benzene ) in spot urine (concentration adjusted for creatinine), during exposure events where some subjects used IQOS. |
| HEMA (Non-Exposure Events) | 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 2-hydroxyethyl mercapturic acid (HEMA, a BoExp to Ethylene Oxide) in spot urine (concentration adjusted for creatinine). |
| HEMA (Exposure Events) | 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 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. |
| 3-Ethenylpyridine (3-EP) [µg/m^3] | 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. | 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. |
| Nicotine [µg/m^3] | 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. | 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) |
| Formaldehyde [µg/m^3] | 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. | 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) |
| Acrolein [µg/m^3] | 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. | 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) |
| Crotonaldehyde [µg/m^3] | 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. | 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) |
| NNK [µg/m^3] | 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. | 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. |
| PM1 Particles [µg/m^3] | 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. | Real-time measurements of PM1 suspended particles in air. (ISO Norm 18144:2003) |
| PM2.5 Particles [µg/m^3] | 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. | Real-time measurements of PM2.5 suspended particles in air. (ISO Norm 18144:2003) |
| Acetaldehyde [µg/m^3] | 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. | 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) |
| NNN [µg/m^3] | 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. | 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. |
| HPMA (Non-Exposure Events) | 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 3-hydroxy-1-methylpropylmercapturic acid (HMPMA, a BoExp to Crotonaldehyde ) in spot urine (concentration adjusted for creatinine). |
| HPMA (Exposure Events) | 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 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. |
| 3-HPMA (Non-Exposure Events) | 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 3 hydroxypropylmercapturic acid (3-HPMA, a BoExp to Acrolein) in spot urine (concentration adjusted for creatinine). |
| 3-HPMA (Exposure Events) | 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 3 hydroxypropylmercapturic acid (3-HPMA, a BoExp to Acrolein) in spot urine (concentration adjusted for creatinine), during exposure events where some subjects used IQOS. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Non-Smokers * 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.). | 190 |
| Cigarette Smokers * 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) | 74 |
| IQOS Passive Users (Not Using IQOS) * 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.) | 77 |
| IQOS Active Users (Using IQOS) * 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.) | 60 |
| Total | 401 |
Baseline characteristics
| Characteristic | Non-Smokers | Cigarette Smokers | IQOS Passive Users (Not Using IQOS) | IQOS Active Users (Using IQOS) | Total |
|---|---|---|---|---|---|
| Age, Continuous | 44.3 years STANDARD_DEVIATION 12.52 | 49.9 years STANDARD_DEVIATION 14.4 | 43.6 years STANDARD_DEVIATION 11.08 | 38.8 years STANDARD_DEVIATION 11 | 44.4 years STANDARD_DEVIATION 12.79 |
| Race/Ethnicity, Customized Japanese Origin | 190 Participants | 74 Participants | 77 Participants | 60 Participants | 401 Participants |
| Region of Enrollment Japan | 190 participants | 74 participants | 77 participants | 60 participants | 401 participants |
| Sex: Female, Male Female | 77 Participants | 10 Participants | 21 Participants | 13 Participants | 121 Participants |
| Sex: Female, Male Male | 113 Participants | 64 Participants | 56 Participants | 47 Participants | 280 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 190 | 0 / 74 | 0 / 77 | 0 / 60 |
| other Total, other adverse events | 0 / 190 | 0 / 74 | 0 / 77 | 0 / 60 |
| serious Total, serious adverse events | 0 / 190 | 0 / 74 | 0 / 77 | 0 / 60 |
Outcome results
Primary
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.
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).
Population: 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).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Non-Smokers | NEQ: (Exposure Event) | Baseline | 0.04078 mg/g |
| Non-Smokers | NEQ: (Exposure Event) | Final void | 0.06205 mg/g |
| Cigarette Smokers | NEQ: (Exposure Event) | Final void | 2.889 mg/g |
| Cigarette Smokers | NEQ: (Exposure Event) | Baseline | 3.051 mg/g |
| IQOS Passive Users (Not Using IQOS) | NEQ: (Exposure Event) | Baseline | 5.277 mg/g |
| IQOS Passive Users (Not Using IQOS) | NEQ: (Exposure Event) | Final void | 5.974 mg/g |
| IQOS Active Users (Using IQOS) | NEQ: (Exposure Event) | Baseline | 4.683 mg/g |
| IQOS Active Users (Using IQOS) | NEQ: (Exposure Event) | Final void | 8.499 mg/g |
Primary
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).
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).
Population: 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).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Non-Smokers | NEQ: (Non-Exposure Event) | Baseline | 0.03845 mg/g |
| Non-Smokers | NEQ: (Non-Exposure Event) | Final void | 0.06876 mg/g |
| Cigarette Smokers | NEQ: (Non-Exposure Event) | Baseline | 4.159 mg/g |
| Cigarette Smokers | NEQ: (Non-Exposure Event) | Final void | 5.175 mg/g |
| IQOS Passive Users (Not Using IQOS) | NEQ: (Non-Exposure Event) | Baseline | 5.695 mg/g |
| IQOS Passive Users (Not Using IQOS) | NEQ: (Non-Exposure Event) | Final void | 6.821 mg/g |
Primary
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.
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).
Population: 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).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Non-Smokers | Total NNAL: (Exposure Event) | Baseline | NA ng/g |
| Non-Smokers | Total NNAL: (Exposure Event) | Final Void | NA ng/g |
| Cigarette Smokers | Total NNAL: (Exposure Event) | Final Void | 58.74 ng/g |
| Cigarette Smokers | Total NNAL: (Exposure Event) | Baseline | 48.57 ng/g |
| IQOS Passive Users (Not Using IQOS) | Total NNAL: (Exposure Event) | Baseline | 19.68 ng/g |
| IQOS Passive Users (Not Using IQOS) | Total NNAL: (Exposure Event) | Final Void | 20.31 ng/g |
| IQOS Active Users (Using IQOS) | Total NNAL: (Exposure Event) | Baseline | 21.50 ng/g |
| IQOS Active Users (Using IQOS) | Total NNAL: (Exposure Event) | Final Void | 30.45 ng/g |
Primary
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).
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).
Population: 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).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Non-Smokers | Total NNAL: (Non-Exposure Event) | Baseline | NA ng/g |
| Non-Smokers | Total NNAL: (Non-Exposure Event) | Final Void | NA ng/g |
| Cigarette Smokers | Total NNAL: (Non-Exposure Event) | Baseline | 69.65 ng/g |
| Cigarette Smokers | Total NNAL: (Non-Exposure Event) | Final Void | 81.64 ng/g |
| IQOS Passive Users (Not Using IQOS) | Total NNAL: (Non-Exposure Event) | Baseline | 20.55 ng/g |
| IQOS Passive Users (Not Using IQOS) | Total NNAL: (Non-Exposure Event) | Final Void | 27.41 ng/g |
Primary
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.
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).
Population: 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).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Non-Smokers | Total NNN: (Exposure Event) | Baseline | NA ng/g |
| Non-Smokers | Total NNN: (Exposure Event) | Final Void | NA ng/g |
| Cigarette Smokers | Total NNN: (Exposure Event) | Final Void | 3.992 ng/g |
| Cigarette Smokers | Total NNN: (Exposure Event) | Baseline | 2.694 ng/g |
| IQOS Passive Users (Not Using IQOS) | Total NNN: (Exposure Event) | Baseline | 1.753 ng/g |
| IQOS Passive Users (Not Using IQOS) | Total NNN: (Exposure Event) | Final Void | 2.034 ng/g |
| IQOS Active Users (Using IQOS) | Total NNN: (Exposure Event) | Baseline | 0.9088 ng/g |
| IQOS Active Users (Using IQOS) | Total NNN: (Exposure Event) | Final Void | 2.347 ng/g |
Primary
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).
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).
Population: 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).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Non-Smokers | Total NNN: (Non-Exposure Event) | Baseline | NA ng/g |
| Non-Smokers | Total NNN: (Non-Exposure Event) | Final Void | NA ng/g |
| Cigarette Smokers | Total NNN: (Non-Exposure Event) | Baseline | 3.945 ng/g |
| Cigarette Smokers | Total NNN: (Non-Exposure Event) | Final Void | 4.008 ng/g |
| IQOS Passive Users (Not Using IQOS) | Total NNN: (Non-Exposure Event) | Baseline | 1.493 ng/g |
| IQOS Passive Users (Not Using IQOS) | Total NNN: (Non-Exposure Event) | Final Void | 3.093 ng/g |
Secondary
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.
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non-Smokers | 3-Ethenylpyridine (3-EP) [µg/m^3] | Prior to Event | NA µg/m^3 |
| Non-Smokers | 3-Ethenylpyridine (3-EP) [µg/m^3] | End of Event | NA µg/m^3 |
| Cigarette Smokers | 3-Ethenylpyridine (3-EP) [µg/m^3] | Prior to Event | NA µg/m^3 |
| Cigarette Smokers | 3-Ethenylpyridine (3-EP) [µg/m^3] | End of Event | NA µg/m^3 |
Secondary
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.
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).
Population: 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).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Non-Smokers | 3-HPMA (Exposure Events) | Baseline | 246.6 μg/g |
| Non-Smokers | 3-HPMA (Exposure Events) | Final Void | 1982 μg/g |
| Cigarette Smokers | 3-HPMA (Exposure Events) | Final Void | 2051 μg/g |
| Cigarette Smokers | 3-HPMA (Exposure Events) | Baseline | 840.6 μg/g |
| IQOS Passive Users (Not Using IQOS) | 3-HPMA (Exposure Events) | Baseline | 404.4 μg/g |
| IQOS Passive Users (Not Using IQOS) | 3-HPMA (Exposure Events) | Final Void | 1938 μg/g |
| IQOS Active Users (Using IQOS) | 3-HPMA (Exposure Events) | Baseline | 381.1 μg/g |
| IQOS Active Users (Using IQOS) | 3-HPMA (Exposure Events) | Final Void | 1729 μg/g |
Secondary
3-HPMA (Non-Exposure Events)
To measure 3 hydroxypropylmercapturic acid (3-HPMA, a BoExp to Acrolein) in spot urine (concentration adjusted for creatinine).
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).
Population: 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).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Non-Smokers | 3-HPMA (Non-Exposure Events) | Baseline | 242.1 μg/g |
| Non-Smokers | 3-HPMA (Non-Exposure Events) | Final Void | 1108 μg/g |
| Cigarette Smokers | 3-HPMA (Non-Exposure Events) | Baseline | 935.7 μg/g |
| Cigarette Smokers | 3-HPMA (Non-Exposure Events) | Final Void | 1334 μg/g |
| IQOS Passive Users (Not Using IQOS) | 3-HPMA (Non-Exposure Events) | Baseline | 454.9 μg/g |
| IQOS Passive Users (Not Using IQOS) | 3-HPMA (Non-Exposure Events) | Final Void | 1240 μg/g |
Secondary
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)
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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Non-Smokers | Acetaldehyde [µg/m^3] | Prior to Event | 16.52 µg/m^3 |
| Non-Smokers | Acetaldehyde [µg/m^3] | End of Event | 110 µg/m^3 |
| Cigarette Smokers | Acetaldehyde [µg/m^3] | Prior to Event | 29.20 µg/m^3 |
| Cigarette Smokers | Acetaldehyde [µg/m^3] | End of Event | 187.4 µg/m^3 |
Secondary
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)
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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Non-Smokers | Acrolein [µg/m^3] | Prior to Event | 0.03291 µg/m^3 |
| Non-Smokers | Acrolein [µg/m^3] | End of Event | 0.07368 µg/m^3 |
| Cigarette Smokers | Acrolein [µg/m^3] | Prior to Event | 0.07646 µg/m^3 |
| Cigarette Smokers | Acrolein [µg/m^3] | End of Event | 0.3288 µg/m^3 |
Secondary
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)
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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Non-Smokers | Crotonaldehyde [µg/m^3] | Prior to Event | 0.07621 µg/m^3 |
| Non-Smokers | Crotonaldehyde [µg/m^3] | End of Event | 0.1356 µg/m^3 |
| Cigarette Smokers | Crotonaldehyde [µg/m^3] | Prior to Event | 0.09775 µg/m^3 |
| Cigarette Smokers | Crotonaldehyde [µg/m^3] | End of Event | 0.2523 µg/m^3 |
Secondary
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)
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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Non-Smokers | Formaldehyde [µg/m^3] | Prior to Event | 16.60 µg/m^3 |
| Non-Smokers | Formaldehyde [µg/m^3] | End of Event | 17.49 µg/m^3 |
| Cigarette Smokers | Formaldehyde [µg/m^3] | Prior to Event | 17.15 µg/m^3 |
| Cigarette Smokers | Formaldehyde [µg/m^3] | End of Event | 22.74 µg/m^3 |
Secondary
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.
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).
Population: 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).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Non-Smokers | HEMA (Exposure Events) | Baseline | 651.3 ng/g |
| Non-Smokers | HEMA (Exposure Events) | Final Void | 1486 ng/g |
| Cigarette Smokers | HEMA (Exposure Events) | Final Void | 1967 ng/g |
| Cigarette Smokers | HEMA (Exposure Events) | Baseline | 1143 ng/g |
| IQOS Passive Users (Not Using IQOS) | HEMA (Exposure Events) | Baseline | 675.0 ng/g |
| IQOS Passive Users (Not Using IQOS) | HEMA (Exposure Events) | Final Void | 1440 ng/g |
| IQOS Active Users (Using IQOS) | HEMA (Exposure Events) | Baseline | 705.0 ng/g |
| IQOS Active Users (Using IQOS) | HEMA (Exposure Events) | Final Void | 1513 ng/g |
Secondary
HEMA (Non-Exposure Events)
To measure 2-hydroxyethyl mercapturic acid (HEMA, a BoExp to Ethylene Oxide) in spot urine (concentration adjusted for creatinine).
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).
Population: 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).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Non-Smokers | HEMA (Non-Exposure Events) | Baseline | 635.1 ng/g |
| Non-Smokers | HEMA (Non-Exposure Events) | Final Void | 1299 ng/g |
| Cigarette Smokers | HEMA (Non-Exposure Events) | Baseline | 1671 ng/g |
| Cigarette Smokers | HEMA (Non-Exposure Events) | Final Void | 2595 ng/g |
| IQOS Passive Users (Not Using IQOS) | HEMA (Non-Exposure Events) | Baseline | 629.1 ng/g |
| IQOS Passive Users (Not Using IQOS) | HEMA (Non-Exposure Events) | Final Void | 1520 ng/g |
Secondary
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.
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).
Population: 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).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Non-Smokers | HPMA (Exposure Events) | Baseline | 82.91 μg/g |
| Non-Smokers | HPMA (Exposure Events) | Final void | 170.9 μg/g |
| Cigarette Smokers | HPMA (Exposure Events) | Final void | 224.1 μg/g |
| Cigarette Smokers | HPMA (Exposure Events) | Baseline | 233.4 μg/g |
| IQOS Passive Users (Not Using IQOS) | HPMA (Exposure Events) | Baseline | 92.85 μg/g |
| IQOS Passive Users (Not Using IQOS) | HPMA (Exposure Events) | Final void | 166.7 μg/g |
| IQOS Active Users (Using IQOS) | HPMA (Exposure Events) | Baseline | 103.0 μg/g |
| IQOS Active Users (Using IQOS) | HPMA (Exposure Events) | Final void | 195.3 μg/g |
Secondary
HPMA (Non-Exposure Events)
To measure 3-hydroxy-1-methylpropylmercapturic acid (HMPMA, a BoExp to Crotonaldehyde ) in spot urine (concentration adjusted for creatinine).
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).
Population: 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).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Non-Smokers | HPMA (Non-Exposure Events) | Baseline | 103.2 μg/g |
| Non-Smokers | HPMA (Non-Exposure Events) | Final void | 232.6 μg/g |
| Cigarette Smokers | HPMA (Non-Exposure Events) | Baseline | 318.6 μg/g |
| Cigarette Smokers | HPMA (Non-Exposure Events) | Final void | 307.7 μg/g |
| IQOS Passive Users (Not Using IQOS) | HPMA (Non-Exposure Events) | Baseline | 133.2 μg/g |
| IQOS Passive Users (Not Using IQOS) | HPMA (Non-Exposure Events) | Final void | 211.9 μg/g |
Secondary
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)
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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Non-Smokers | Nicotine [µg/m^3] | Prior to Event | NA µg/m^3 |
| Non-Smokers | Nicotine [µg/m^3] | End of Event | NA µg/m^3 |
| Cigarette Smokers | Nicotine [µg/m^3] | Prior to Event | NA µg/m^3 |
| Cigarette Smokers | Nicotine [µg/m^3] | End of Event | 0.9776 µg/m^3 |
Secondary
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.
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non-Smokers | NNK [µg/m^3] | Prior to Event | NA µg/m^3 |
| Non-Smokers | NNK [µg/m^3] | End of Event | NA µg/m^3 |
| Cigarette Smokers | NNK [µg/m^3] | Prior to Event | NA µg/m^3 |
| Cigarette Smokers | NNK [µg/m^3] | End of Event | NA µg/m^3 |
Secondary
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.
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non-Smokers | NNN [µg/m^3] | Prior to Event | NA µg/m^3 |
| Non-Smokers | NNN [µg/m^3] | End of Event | NA µg/m^3 |
| Cigarette Smokers | NNN [µg/m^3] | Prior to Event | NA µg/m^3 |
| Cigarette Smokers | NNN [µg/m^3] | End of Event | NA µg/m^3 |
Secondary
PM1 Particles [µg/m^3]
Real-time measurements of PM1 suspended particles in air. (ISO Norm 18144:2003)
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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Non-Smokers | PM1 Particles [µg/m^3] | Prior to Event | 1.489 µg/m^3 |
| Non-Smokers | PM1 Particles [µg/m^3] | End of Event | 11.508 µg/m^3 |
| Cigarette Smokers | PM1 Particles [µg/m^3] | Prior to Event | 1.251 µg/m^3 |
| Cigarette Smokers | PM1 Particles [µg/m^3] | End of Event | 9.991 µg/m^3 |
Secondary
PM2.5 Particles [µg/m^3]
Real-time measurements of PM2.5 suspended particles in air. (ISO Norm 18144:2003)
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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Non-Smokers | PM2.5 Particles [µg/m^3] | Prior to Event | 1.585 µg/m^3 |
| Non-Smokers | PM2.5 Particles [µg/m^3] | End of Event | 12.648 µg/m^3 |
| Cigarette Smokers | PM2.5 Particles [µg/m^3] | Prior to Event | 1.340 µg/m^3 |
| Cigarette Smokers | PM2.5 Particles [µg/m^3] | End of Event | 10.755 µg/m^3 |
Secondary
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.
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).
Population: 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).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Non-Smokers | S-PMA (Exposure Events) | Baseline | 123.5 ng/g |
| Non-Smokers | S-PMA (Exposure Events) | Final Void | 136.9 ng/g |
| Cigarette Smokers | S-PMA (Exposure Events) | Final Void | 612.5 ng/g |
| Cigarette Smokers | S-PMA (Exposure Events) | Baseline | 735.1 ng/g |
| IQOS Passive Users (Not Using IQOS) | S-PMA (Exposure Events) | Baseline | 151.9 ng/g |
| IQOS Passive Users (Not Using IQOS) | S-PMA (Exposure Events) | Final Void | 156.7 ng/g |
| IQOS Active Users (Using IQOS) | S-PMA (Exposure Events) | Baseline | 195.3 ng/g |
| IQOS Active Users (Using IQOS) | S-PMA (Exposure Events) | Final Void | 229.3 ng/g |
Secondary
S-PMA (Non-Exposure Events)
To measure S-phenylmercapturic acid (S-PMA, a BoExp to Benzene) in spot urine (concentration adjusted for creatinine).
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).
Population: 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).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Non-Smokers | S-PMA (Non-Exposure Events) | Baseline | 113.2 ng/g |
| Non-Smokers | S-PMA (Non-Exposure Events) | Final Void | 132.0 ng/g |
| Cigarette Smokers | S-PMA (Non-Exposure Events) | Baseline | 1441 ng/g |
| Cigarette Smokers | S-PMA (Non-Exposure Events) | Final Void | 1023 ng/g |
| IQOS Passive Users (Not Using IQOS) | S-PMA (Non-Exposure Events) | Baseline | 192.6 ng/g |
| IQOS Passive Users (Not Using IQOS) | S-PMA (Non-Exposure Events) | Final Void | 201.3 ng/g |