Real-Life Passive Exposure Assessment of IQOS | NCT03550989 | Trialant
NCT03550989
Sponsor
Philip Morris Products S.A.
Status
Completed
Last Update Posted
Aug 28, 2019Actual
Enrollment
401Actual
Phase
Not provided
Conditions
Environmental Exposure
Interventions
Non-Exposure Event
Exposure Event
Countries
Japan
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Derived Section
Miscellaneous Info Module
Version Holder
NCT03550989
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
P1-PES-01-JP
Secondary IDs
Not provided
Brief Title
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.
Acronym
Not provided
Organization
Philip Morris Products S.A.INDUSTRY
Status Module
Record Verification Date
Aug 2019
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 5, 2017Actual
Primary Completion Date
Apr 30, 2018Actual
Completion Date
May 16, 2018Actual
First Submitted Date
Mar 20, 2018
First Submission Date that Met QC Criteria
May 25, 2018
First Posted Date
Jun 11, 2018Actual
Results Waived
Not provided
Results First Submitted Date
May 23, 2019
Results First Submitted that Met QC Criteria
May 23, 2019
Results First Posted Date
Jul 29, 2019Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Aug 19, 2019
Last Update Posted Date
Aug 28, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Philip Morris Products S.A.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
No
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
Conditions Module
Conditions
Environmental Exposure
Keywords
Environmental Aerosol Exposure
Environmental Tobacco Smoke
Indoor Air Quality
Design Module
Study Type
Observational
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
No
Target Follow-Up Duration
Not provided
Phases
Not provided
Interventional Study Design
Allocation
Not provided
Intervention Model
Biospecimen
No data available
No data is available for this block.
Enrollment
401Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
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.).
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)
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.)
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.)
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Non-Exposure Event
Other
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.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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 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 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 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 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
Description
Time Frame
HPMA (Non-Exposure Events)
To measure 3-hydroxy-1-methylpropylmercapturic acid (HMPMA, a BoExp to Crotonaldehyde ) in spot urine (concentration adjusted for creatinine).
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).
Other Outcomes
Not provided
Eligibility Module
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.
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
20 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Female or male Japanese IQOS Users, Cigarette smokers, or Non-Smokers.
Sampling Method
Non-Probability Sample
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Patrick Picavet, MD
Philip Morris Products S.A.
Study Chair
Takao Ohki, MD, PhD
Jikei University School of Medicine, Tokyo
Principal Investigator
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Angepatio Restaurant
Shibuya-ku
Tokyo
150-0036
Japan
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
Undecided
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
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.).
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.
Exposure Event: Exposure Event to measure urinary BoExp to selected HPHCs representative of ETS in all participant groups, with up to 5h of exposure 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).
FG001
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)
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.
Exposure Event: Exposure Event to measure urinary BoExp to selected HPHCs representative of ETS in all participant groups, with up to 5h of exposure 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).
FG002
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.)
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.
Exposure Event: Exposure Event to measure urinary BoExp to selected HPHCs representative of ETS in all participant groups, with up to 5h of exposure 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).
FG003
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.)
Exposure Event: Exposure Event to measure urinary BoExp to selected HPHCs representative of ETS in all participant groups, with up to 5h of exposure 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).
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG000190 subjects
FG00174 subjects
FG00277 subjects
FG00360 subjects
COMPLETED
FG000188 subjects
FG00173 subjects
FG00276 subjects
FG00360 subjects
NOT COMPLETED
FG0002 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
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.).
BG001
Cigarette Smokers
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
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).
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).
Posted
Geometric Mean
95% Confidence Interval
mg/g
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).
ID
Title
Description
OG000
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.).
Adverse Events Module
Frequency Threshold
0
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.
Description
As this study was observational by design and was conducted in a post-market setting, adverse event (AE) reporting followed the Sponsor's already established post-market Safety Surveillance Procedures for spontaneously-reported events. In case of a medical event, the study staff were advised to call the local emergency number to ensure appropriate medical treatment. Any related cost for treatment and transportation was to be borne by the Sponsor.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
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.).
Serious Adverse Events
Not provided
Other Adverse Events
Not provided
More Info Module
Limitations and Caveats
Not provided
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Point of Contact
Title
Organization
Phone
Extension
Email
Christelle Haziza, Director Health Science and Biostatistics
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).
Cigarette Smokers
IQOS Active Users (using IQOS)
IQOS Passive Users (not using IQOS)
Non-Smokers
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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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.
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)
BG002
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.)
BG003
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.)
BG004
Total
Total of all reporting groups
190
BG00174
BG00277
BG00360
BG004401
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00044.3± 12.52
BG00149.9± 14.40
BG00243.6± 11.08
BG00338.8± 11.00
BG00444.4± 12.79
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00077
BG00110
BG00221
BG00313
BG004121
Male
BG000113
BG00164
BG00256
BG00347
BG004
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Japanese Origin
Title
Measurements
BG000190
BG00174
BG00277
BG00360
BG004401
Region of Enrollment
Number
participants
Title
Denominators
Categories
Japan
Title
Measurements
BG000190
BG00174
BG00277
BG00360
BG004401
OG001
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)
OG002
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.)
Units
Counts
Participants
OG00077
OG00132
OG00232
Title
Denominators
Categories
Baseline
ParticipantsOG00070
ParticipantsOG00127
ParticipantsOG00227
Title
Measurements
OG0000.03845(0.03120 to 0.04739)
OG0014.159(2.253 to 7.678)
OG0025.695(4.286 to 7.567)
Final void
ParticipantsOG00073
ParticipantsOG00130
ParticipantsOG00231
Title
Measurements
OG000
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.
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).
Posted
Geometric Mean
95% Confidence Interval
mg/g
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).
ID
Title
Description
OG000
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.).
OG001
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)
OG002
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.)
OG003
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.)
Units
Counts
Participants
OG000113
OG00142
OG00245
OG003
Title
Denominators
Categories
Baseline
ParticipantsOG000112
ParticipantsOG00138
ParticipantsOG00244
ParticipantsOG003
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).
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).
Posted
Geometric Mean
95% Confidence Interval
ng/g
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).
ID
Title
Description
OG000
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.).
OG001
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)
OG002
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.)
Units
Counts
Participants
OG00077
OG00132
OG00232
Title
Denominators
Categories
Baseline
ParticipantsOG00074
ParticipantsOG00127
ParticipantsOG00228
Title
Measurements
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.
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).
Posted
Geometric Mean
95% Confidence Interval
ng/g
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).
ID
Title
Description
OG000
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.).
OG001
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)
OG002
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.)
OG003
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.)
Units
Counts
Participants
OG000113
OG00142
OG00245
OG003
Title
Denominators
Categories
Baseline
ParticipantsOG000113
ParticipantsOG00138
ParticipantsOG00244
ParticipantsOG003
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).
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).
Posted
Geometric Mean
95% Confidence Interval
ng/g
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).
ID
Title
Description
OG000
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.).
OG001
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)
OG002
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.)
Units
Counts
Participants
OG00077
OG00132
OG00232
Title
Denominators
Categories
Baseline
ParticipantsOG00074
ParticipantsOG00127
ParticipantsOG00227
Title
Measurements
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.
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).
Posted
Geometric Mean
95% Confidence Interval
ng/g
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).
ID
Title
Description
OG000
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.).
OG001
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)
OG002
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.)
OG003
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.)
Units
Counts
Participants
OG000113
OG00142
OG00245
OG003
Title
Denominators
Categories
Baseline
ParticipantsOG000112
ParticipantsOG00138
ParticipantsOG00244
ParticipantsOG003
Secondary
HPMA (Non-Exposure Events)
To measure 3-hydroxy-1-methylpropylmercapturic acid (HMPMA, a BoExp to Crotonaldehyde ) in spot urine (concentration adjusted for creatinine).
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).
Posted
Geometric Mean
95% Confidence Interval
μg/g
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).
ID
Title
Description
OG000
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.).
OG001
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)
OG002
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.)
Units
Counts
Participants
OG00077
OG00132
OG00232
Title
Denominators
Categories
Baseline
ParticipantsOG00070
ParticipantsOG00127
ParticipantsOG00227
Title
Measurements
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.
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).
Posted
Geometric Mean
95% Confidence Interval
μg/g
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).
ID
Title
Description
OG000
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.).
OG001
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)
OG002
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.)
OG003
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.)
Units
Counts
Participants
OG000113
OG00142
OG00245
OG003
Title
Denominators
Categories
Baseline
ParticipantsOG000112
ParticipantsOG00138
ParticipantsOG00243
ParticipantsOG003
Secondary
3-HPMA (Non-Exposure Events)
To measure 3 hydroxypropylmercapturic acid (3-HPMA, a BoExp to Acrolein) in spot urine (concentration adjusted for creatinine).
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).
Posted
Geometric Mean
95% Confidence Interval
μg/g
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).
ID
Title
Description
OG000
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.).
OG001
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)
OG002
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.)
Units
Counts
Participants
OG00077
OG00132
OG00232
Title
Denominators
Categories
Baseline
ParticipantsOG00070
ParticipantsOG00127
ParticipantsOG00227
Title
Measurements
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.
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).
Posted
Geometric Mean
95% Confidence Interval
μg/g
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).
ID
Title
Description
OG000
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.).
OG001
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)
OG002
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.)
OG003
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.)
Units
Counts
Participants
OG000113
OG00142
OG00245
OG003
Title
Denominators
Categories
Baseline
ParticipantsOG000112
ParticipantsOG00138
ParticipantsOG00243
ParticipantsOG003
Secondary
S-PMA (Non-Exposure Events)
To measure S-phenylmercapturic acid (S-PMA, a BoExp to Benzene) in spot urine (concentration adjusted for creatinine).
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).
Posted
Geometric Mean
95% Confidence Interval
ng/g
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).
ID
Title
Description
OG000
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.).
OG001
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)
OG002
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.)
Units
Counts
Participants
OG00077
OG00132
OG00232
Title
Denominators
Categories
Baseline
ParticipantsOG00070
ParticipantsOG00127
ParticipantsOG00227
Title
Measurements
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.
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).
Posted
Geometric Mean
95% Confidence Interval
ng/g
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).
ID
Title
Description
OG000
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.).
OG001
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)
OG002
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.)
OG003
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.)
Units
Counts
Participants
OG000113
OG00142
OG00245
OG003
Title
Denominators
Categories
Baseline
ParticipantsOG000112
ParticipantsOG00138
ParticipantsOG00243
ParticipantsOG003
Secondary
HEMA (Non-Exposure Events)
To measure 2-hydroxyethyl mercapturic acid (HEMA, a BoExp to Ethylene Oxide) in spot urine (concentration adjusted for creatinine).
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).
Posted
Geometric Mean
95% Confidence Interval
ng/g
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).
ID
Title
Description
OG000
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.).
OG001
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)
OG002
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.)
Units
Counts
Participants
OG00077
OG00132
OG00232
Title
Denominators
Categories
Baseline
ParticipantsOG00070
ParticipantsOG00127
ParticipantsOG00227
Title
Measurements
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.
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).
Posted
Geometric Mean
95% Confidence Interval
ng/g
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).
ID
Title
Description
OG000
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.).
OG001
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)
OG002
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.)
OG003
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.)
Units
Counts
Participants
OG000113
OG00142
OG00245
OG003
Title
Denominators
Categories
Baseline
ParticipantsOG000112
ParticipantsOG00138
ParticipantsOG00243
ParticipantsOG003
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.
Posted
Number
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.
ID
Title
Description
OG000
Non-Exposure Event
For Non-Exposure Events, Indoor Air Quality measurements were performed at the Event location for up to 3h prior to the start of the Event and for 3h after the last participant has entered the Event for 1h.
OG001
Exposure Event
For Exposure Events, Indoor Air Quality (IAQ) measurements were performed at the Event location for up to 3h prior to start of the Exposure and for 3h after the last participant had been exposed for 1h to quantify and differentiate background exposure and to assess the impact of IQOS use on IAQ.
Units
Counts
Participants
OG000141
OG001260
Title
Denominators
Categories
Prior to Event
Title
Measurements
OG000NABelow the limit of detection.
OG001NABelow the limit of detection.
End of Event
Title
Measurements
OG000
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)
Posted
Geometric Mean
95% Confidence Interval
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.
ID
Title
Description
OG000
Non-Exposure Event
For Non-Exposure Events, Indoor Air Quality measurements were performed at the Event location for up to 3h prior to the start of the Event and for 3h after the last participant has entered the Event for 1h.
OG001
Exposure Event
For Exposure Events, Indoor Air Quality (IAQ) measurements were performed at the Event location for up to 3h prior to start of the Exposure and for 3h after the last participant had been exposed for 1h to quantify and differentiate background exposure and to assess the impact of IQOS use on IAQ.
Units
Counts
Participants
OG000141
OG001260
Title
Denominators
Categories
Prior to Event
Title
Measurements
OG000NA(NA to NA)Below the limit of detection.
OG001NA(NA to NA)Below the limit of detection.
End of Event
Title
Measurements
OG000
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)
Posted
Geometric Mean
95% Confidence Interval
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.
ID
Title
Description
OG000
Non-Exposure Event
For Non-Exposure Events, Indoor Air Quality measurements were performed at the Event location for up to 3h prior to the start of the Event and for 3h after the last participant has entered the Event for 1h.
OG001
Exposure Event
For Exposure Events, Indoor Air Quality (IAQ) measurements were performed at the Event location for up to 3h prior to start of the Exposure and for 3h after the last participant had been exposed for 1h to quantify and differentiate background exposure and to assess the impact of IQOS use on IAQ.
Units
Counts
Participants
OG000141
OG001260
Title
Denominators
Categories
Prior to Event
Title
Measurements
OG00016.52(15.50 to 17.60)
OG00129.20(26.02 to 32.78)
End of Event
Title
Measurements
OG000
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)
Posted
Geometric Mean
95% Confidence Interval
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.
ID
Title
Description
OG000
Non-Exposure Event
For Non-Exposure Events, Indoor Air Quality measurements were performed at the Event location for up to 3h prior to the start of the Event and for 3h after the last participant has entered the Event for 1h.
OG001
Exposure Event
For Exposure Events, Indoor Air Quality (IAQ) measurements were performed at the Event location for up to 3h prior to start of the Exposure and for 3h after the last participant had been exposed for 1h to quantify and differentiate background exposure and to assess the impact of IQOS use on IAQ.
Units
Counts
Participants
OG000141
OG001260
Title
Denominators
Categories
Prior to Event
Title
Measurements
OG0000.03291(0.02976 to 0.03639)
OG0010.07646(0.06749 to 0.08662)
End of Event
Title
Measurements
OG000
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)
Posted
Geometric Mean
95% Confidence Interval
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.
ID
Title
Description
OG000
Non-Exposure Event
For Non-Exposure Events, Indoor Air Quality measurements were performed at the Event location for up to 3h prior to the start of the Event and for 3h after the last participant has entered the Event for 1h.
OG001
Exposure Event
For Exposure Events, Indoor Air Quality (IAQ) measurements were performed at the Event location for up to 3h prior to start of the Exposure and for 3h after the last participant had been exposed for 1h to quantify and differentiate background exposure and to assess the impact of IQOS use on IAQ.
Units
Counts
Participants
OG000141
OG001260
Title
Denominators
Categories
Prior to Event
Title
Measurements
OG0000.07621(0.07024 to 0.08269)
OG0010.09775(0.09048 to 0.1056)
End of Event
Title
Measurements
OG000
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)
Posted
Geometric Mean
95% Confidence Interval
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.
ID
Title
Description
OG000
Non-Exposure Event
For Non-Exposure Events, Indoor Air Quality measurements were performed at the Event location for up to 3h prior to the start of the Event and for 3h after the last participant has entered the Event for 1h.
OG001
Exposure Event
For Exposure Events, Indoor Air Quality (IAQ) measurements were performed at the Event location for up to 3h prior to start of the Exposure and for 3h after the last participant had been exposed for 1h to quantify and differentiate background exposure and to assess the impact of IQOS use on IAQ.
Units
Counts
Participants
OG000141
OG001260
Title
Denominators
Categories
Prior to Event
Title
Measurements
OG00016.60(15.42 to 17.87)
OG00117.15(16.20 to 18.16)
End of Event
Title
Measurements
OG000
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.
Posted
Number
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.
ID
Title
Description
OG000
Non-Exposure Event
For Non-Exposure Events, Indoor Air Quality measurements were performed at the Event location for up to 3h prior to the start of the Event and for 3h after the last participant has entered the Event for 1h.
OG001
Exposure Event
For Exposure Events, Indoor Air Quality (IAQ) measurements were performed at the Event location for up to 3h prior to start of the Exposure and for 3h after the last participant had been exposed for 1h to quantify and differentiate background exposure and to assess the impact of IQOS use on IAQ.
Units
Counts
Participants
OG000141
OG001260
Title
Denominators
Categories
Prior to Event
Title
Measurements
OG000NABelow the limit of detection.
OG001NABelow the limit of detection.
End of Event
Title
Measurements
OG000
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.
Posted
Number
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.
ID
Title
Description
OG000
Non-Exposure Event
For Non-Exposure Events, Indoor Air Quality measurements were performed at the Event location for up to 3h prior to the start of the Event and for 3h after the last participant has entered the Event for 1h.
OG001
Exposure Event
For Exposure Events, Indoor Air Quality (IAQ) measurements were performed at the Event location for up to 3h prior to start of the Exposure and for 3h after the last participant had been exposed for 1h to quantify and differentiate background exposure and to assess the impact of IQOS use on IAQ.
Units
Counts
Participants
OG000141
OG001260
Title
Denominators
Categories
Prior to Event
Title
Measurements
OG000NABelow the limit of detection.
OG001NABelow the limit of detection.
End of Event
Title
Measurements
OG000
Secondary
PM1 Particles [µg/m^3]
Real-time measurements of PM1 suspended particles in air. (ISO Norm 18144:2003)
Posted
Mean
95% Confidence Interval
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.
ID
Title
Description
OG000
Non-Exposure Event
For Non-Exposure Events, Indoor Air Quality measurements were performed at the Event location for up to 3h prior to the start of the Event and for 3h after the last participant has entered the Event for 1h.
OG001
Exposure Event
For Exposure Events, Indoor Air Quality (IAQ) measurements were performed at the Event location for up to 3h prior to start of the Exposure and for 3h after the last participant had been exposed for 1h to quantify and differentiate background exposure and to assess the impact of IQOS use on IAQ.
Units
Counts
Participants
OG000141
OG001260
Title
Denominators
Categories
Prior to Event
Title
Measurements
OG0001.489(1.367 to 1.611)
OG0011.251(1.150 to 1.353)
End of Event
Title
Measurements
OG000
Secondary
PM2.5 Particles [µg/m^3]
Real-time measurements of PM2.5 suspended particles in air. (ISO Norm 18144:2003)
Posted
Mean
95% Confidence Interval
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.
ID
Title
Description
OG000
Non-Exposure Event
For Non-Exposure Events, Indoor Air Quality measurements were performed at the Event location for up to 3h prior to the start of the Event and for 3h after the last participant has entered the Event for 1h.
OG001
Exposure Event
For Exposure Events, Indoor Air Quality (IAQ) measurements were performed at the Event location for up to 3h prior to start of the Exposure and for 3h after the last participant had been exposed for 1h to quantify and differentiate background exposure and to assess the impact of IQOS use on IAQ.
Units
Counts
Participants
OG000141
OG001260
Title
Denominators
Categories
Prior to Event
Title
Measurements
OG0001.585(1.460 to 1.710)
OG0011.340(1.239 to 1.441)
End of Event
Title
Measurements
OG000
0
190
0
190
0
190
EG001
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)
0
74
0
74
0
74
EG002
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.)
0
77
0
77
0
77
EG003
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.)
0
60
0
60
0
60
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
We confirm we have the contractual provisions in place which specify that in no event will the study site be allowed to disclose to any third party (or publicly release) any information obtained through the study without the CRO's prior written consent which in turn cannot provide such consent without Sponsor's approval unless such publication is made to satisfy regulatory requirements.
The Intellectual Property rights and research results from the present study belong to the Sponsor.
280
0.06876
(0.05527 to 0.08553)
OG0015.175(2.902 to 9.228)
OG0026.821(5.127 to 9.074)
60
59
Title
Measurements
OG0000.04078(0.03397 to 0.04896)
OG0013.051(1.720 to 5.414)
OG0025.277(4.018 to 6.930)
OG0034.683(3.553 to 6.171)
Final void
ParticipantsOG000112
ParticipantsOG00142
ParticipantsOG00245
ParticipantsOG00360
Title
Measurements
OG0000.06205(0.05000 to 0.07700)
OG0012.889(1.573 to 5.308)
OG0025.974(4.696 to 7.598)
OG003
OG000NA(NA to NA)Below the limit of quantification.
OG00169.65(46.62 to 104.0)
OG00220.55(13.91 to 30.36)
Final Void
ParticipantsOG00075
ParticipantsOG00126
ParticipantsOG00231
Title
Measurements
OG000NA(NA to NA)Below the limit of quantification.
OG00181.64(59.48 to 112.1)
OG00227.41(18.88 to 39.80)
60
59
Title
Measurements
OG000NA(NA to NA)Below the limit of quantification.
OG00148.57(34.57 to 68.25)
OG00219.68(15.78 to 24.56)
OG00321.50(16.29 to 28.38)
Final Void
ParticipantsOG000113
ParticipantsOG00142
ParticipantsOG00245
ParticipantsOG00358
Title
Measurements
OG000NA(NA to NA)Below the limit of quantification.
OG00158.74(45.76 to 75.39)
OG00220.31(15.83 to 26.06)
OG003
OG000NA(NA to NA)Below the limit of quantification.
OG0013.945(2.885 to 5.392)
OG0021.493(0.9808 to 2.272)
Final Void
ParticipantsOG00075
ParticipantsOG00125
ParticipantsOG00229
Title
Measurements
OG000NA(NA to NA)Below the limit of quantification.
OG0014.008(2.395 to 6.708)
OG0023.093(1.826 to 5.240)
60
58
Title
Measurements
OG000NA(NA to NA)Below the limit of quantification.
OG0012.694(1.843 to 3.939)
OG0021.753(1.396 to 2.201)
OG0030.9088(0.6614 to 1.249)
Final Void
ParticipantsOG000113
ParticipantsOG00142
ParticipantsOG00245
ParticipantsOG00356
Title
Measurements
OG000NA(NA to NA)Below the limit of quantification.