Trial Outcomes & Findings for Real-Life Passive Exposure Assessment of IQOS (NCT NCT03550989)
NCT ID: NCT03550989
Last Updated: 2019-08-28
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
401 participants
Primary outcome timeframe
Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).
Results posted on
2019-08-28
Participant Flow
Participant milestones
| Measure |
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).
|
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).
|
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).
|
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).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
190
|
74
|
77
|
60
|
|
Overall Study
COMPLETED
|
188
|
73
|
76
|
60
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Real-Life Passive Exposure Assessment of IQOS
Baseline characteristics by cohort
| Measure |
Non-Smokers
n=190 Participants
* Abstinent for at least 12 months from the use of any nicotine and/or tobacco-containing product based on self-reporting.
* Must not be exposed to tobacco or nicotine-containing products use in any other substantial way (family, partner, workplace, etc.).
|
Cigarette Smokers
n=74 Participants
* Used at least 100 cigarettes
* Smokes cigarettes daily \> 1/day
* Uses IQOS less than daily
* Uses less than 30 HeatSticks/month
* Cigarette is \> 95% of tobacco/nicotine product (all product use)
|
IQOS Passive Users (Not Using IQOS)
n=77 Participants
* Used at least 100 HeatSticks
* Uses IQOS daily \> 1/day
* Smokes a cigarette less than daily
* Smokes less than 30 cigarettes/month
* IQOS is \> 95% of tobacco/nicotine product (all product use)
* excluding other products (e-cig/Ploom/etc.)
|
IQOS Active Users (Using IQOS)
n=60 Participants
* 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.)
|
Total
n=401 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
44.3 years
STANDARD_DEVIATION 12.52 • n=5 Participants
|
49.9 years
STANDARD_DEVIATION 14.40 • n=7 Participants
|
43.6 years
STANDARD_DEVIATION 11.08 • n=5 Participants
|
38.8 years
STANDARD_DEVIATION 11.00 • n=4 Participants
|
44.4 years
STANDARD_DEVIATION 12.79 • n=21 Participants
|
|
Sex: Female, Male
Female
|
77 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
121 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
113 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
280 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Japanese Origin
|
190 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
401 Participants
n=21 Participants
|
|
Region of Enrollment
Japan
|
190 participants
n=5 Participants
|
74 participants
n=7 Participants
|
77 participants
n=5 Participants
|
60 participants
n=4 Participants
|
401 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).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).
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).
Outcome measures
| Measure |
Non-Smokers
n=77 Participants
* Abstinent for at least 12 months from the use of any nicotine and/or tobacco-containing product based on self-reporting.
* Must not be exposed to tobacco or nicotine-containing products use in any other substantial way (family, partner, workplace, etc.).
|
Cigarette Smokers
n=32 Participants
* Used at least 100 cigarettes
* Smokes cigarettes daily \> 1/day
* Uses IQOS less than daily
* Uses less than 30 HeatSticks/month
* Cigarette is \> 95% of tobacco/nicotine product (all product use)
|
IQOS Passive Users (Not Using IQOS)
n=32 Participants
* Used at least 100 HeatSticks
* Uses IQOS daily \> 1/day
* Smokes a cigarette less than daily
* Smokes less than 30 cigarettes/month
* IQOS is \> 95% of tobacco/nicotine product (all product use)
* excluding other products (e-cig/Ploom/etc.)
|
IQOS Active Users (Using IQOS)
* 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.)
|
|---|---|---|---|---|
|
NEQ: (Non-Exposure Event)
Baseline
|
0.03845 mg/g
Interval 0.0312 to 0.04739
|
4.159 mg/g
Interval 2.253 to 7.678
|
5.695 mg/g
Interval 4.286 to 7.567
|
—
|
|
NEQ: (Non-Exposure Event)
Final void
|
0.06876 mg/g
Interval 0.05527 to 0.08553
|
5.175 mg/g
Interval 2.902 to 9.228
|
6.821 mg/g
Interval 5.127 to 9.074
|
—
|
PRIMARY outcome
Timeframe: Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).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).
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.
Outcome measures
| Measure |
Non-Smokers
n=113 Participants
* Abstinent for at least 12 months from the use of any nicotine and/or tobacco-containing product based on self-reporting.
* Must not be exposed to tobacco or nicotine-containing products use in any other substantial way (family, partner, workplace, etc.).
|
Cigarette Smokers
n=42 Participants
* Used at least 100 cigarettes
* Smokes cigarettes daily \> 1/day
* Uses IQOS less than daily
* Uses less than 30 HeatSticks/month
* Cigarette is \> 95% of tobacco/nicotine product (all product use)
|
IQOS Passive Users (Not Using IQOS)
n=45 Participants
* Used at least 100 HeatSticks
* Uses IQOS daily \> 1/day
* Smokes a cigarette less than daily
* Smokes less than 30 cigarettes/month
* IQOS is \> 95% of tobacco/nicotine product (all product use)
* excluding other products (e-cig/Ploom/etc.)
|
IQOS Active Users (Using IQOS)
n=60 Participants
* 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.)
|
|---|---|---|---|---|
|
NEQ: (Exposure Event)
Baseline
|
0.04078 mg/g
Interval 0.03397 to 0.04896
|
3.051 mg/g
Interval 1.72 to 5.414
|
5.277 mg/g
Interval 4.018 to 6.93
|
4.683 mg/g
Interval 3.553 to 6.171
|
|
NEQ: (Exposure Event)
Final void
|
0.06205 mg/g
Interval 0.05 to 0.077
|
2.889 mg/g
Interval 1.573 to 5.308
|
5.974 mg/g
Interval 4.696 to 7.598
|
8.499 mg/g
Interval 6.667 to 10.83
|
PRIMARY outcome
Timeframe: Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).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).
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).
Outcome measures
| Measure |
Non-Smokers
n=77 Participants
* Abstinent for at least 12 months from the use of any nicotine and/or tobacco-containing product based on self-reporting.
* Must not be exposed to tobacco or nicotine-containing products use in any other substantial way (family, partner, workplace, etc.).
|
Cigarette Smokers
n=32 Participants
* Used at least 100 cigarettes
* Smokes cigarettes daily \> 1/day
* Uses IQOS less than daily
* Uses less than 30 HeatSticks/month
* Cigarette is \> 95% of tobacco/nicotine product (all product use)
|
IQOS Passive Users (Not Using IQOS)
n=32 Participants
* Used at least 100 HeatSticks
* Uses IQOS daily \> 1/day
* Smokes a cigarette less than daily
* Smokes less than 30 cigarettes/month
* IQOS is \> 95% of tobacco/nicotine product (all product use)
* excluding other products (e-cig/Ploom/etc.)
|
IQOS Active Users (Using IQOS)
* 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.)
|
|---|---|---|---|---|
|
Total NNAL: (Non-Exposure Event)
Final Void
|
NA ng/g
Below the limit of quantification.
|
81.64 ng/g
Interval 59.48 to 112.1
|
27.41 ng/g
Interval 18.88 to 39.8
|
—
|
|
Total NNAL: (Non-Exposure Event)
Baseline
|
NA ng/g
Below the limit of quantification.
|
69.65 ng/g
Interval 46.62 to 104.0
|
20.55 ng/g
Interval 13.91 to 30.36
|
—
|
PRIMARY outcome
Timeframe: Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).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).
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.
Outcome measures
| Measure |
Non-Smokers
n=113 Participants
* Abstinent for at least 12 months from the use of any nicotine and/or tobacco-containing product based on self-reporting.
* Must not be exposed to tobacco or nicotine-containing products use in any other substantial way (family, partner, workplace, etc.).
|
Cigarette Smokers
n=42 Participants
* Used at least 100 cigarettes
* Smokes cigarettes daily \> 1/day
* Uses IQOS less than daily
* Uses less than 30 HeatSticks/month
* Cigarette is \> 95% of tobacco/nicotine product (all product use)
|
IQOS Passive Users (Not Using IQOS)
n=45 Participants
* Used at least 100 HeatSticks
* Uses IQOS daily \> 1/day
* Smokes a cigarette less than daily
* Smokes less than 30 cigarettes/month
* IQOS is \> 95% of tobacco/nicotine product (all product use)
* excluding other products (e-cig/Ploom/etc.)
|
IQOS Active Users (Using IQOS)
n=60 Participants
* 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.)
|
|---|---|---|---|---|
|
Total NNAL: (Exposure Event)
Baseline
|
NA ng/g
Below the limit of quantification.
|
48.57 ng/g
Interval 34.57 to 68.25
|
19.68 ng/g
Interval 15.78 to 24.56
|
21.50 ng/g
Interval 16.29 to 28.38
|
|
Total NNAL: (Exposure Event)
Final Void
|
NA ng/g
Below the limit of quantification.
|
58.74 ng/g
Interval 45.76 to 75.39
|
20.31 ng/g
Interval 15.83 to 26.06
|
30.45 ng/g
Interval 23.91 to 38.77
|
PRIMARY outcome
Timeframe: Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).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).
To measure Total N-nitrosonornicotine (Total NNN, a BoExp to Tobacco Specific Nitrosamines) in spot urine (expressed as concentration adjusted to creatinine).
Outcome measures
| Measure |
Non-Smokers
n=77 Participants
* Abstinent for at least 12 months from the use of any nicotine and/or tobacco-containing product based on self-reporting.
* Must not be exposed to tobacco or nicotine-containing products use in any other substantial way (family, partner, workplace, etc.).
|
Cigarette Smokers
n=32 Participants
* Used at least 100 cigarettes
* Smokes cigarettes daily \> 1/day
* Uses IQOS less than daily
* Uses less than 30 HeatSticks/month
* Cigarette is \> 95% of tobacco/nicotine product (all product use)
|
IQOS Passive Users (Not Using IQOS)
n=32 Participants
* Used at least 100 HeatSticks
* Uses IQOS daily \> 1/day
* Smokes a cigarette less than daily
* Smokes less than 30 cigarettes/month
* IQOS is \> 95% of tobacco/nicotine product (all product use)
* excluding other products (e-cig/Ploom/etc.)
|
IQOS Active Users (Using IQOS)
* 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.)
|
|---|---|---|---|---|
|
Total NNN: (Non-Exposure Event)
Baseline
|
NA ng/g
Below the limit of quantification.
|
3.945 ng/g
Interval 2.885 to 5.392
|
1.493 ng/g
Interval 0.9808 to 2.272
|
—
|
|
Total NNN: (Non-Exposure Event)
Final Void
|
NA ng/g
Below the limit of quantification.
|
4.008 ng/g
Interval 2.395 to 6.708
|
3.093 ng/g
Interval 1.826 to 5.24
|
—
|
PRIMARY outcome
Timeframe: Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).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).
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.
Outcome measures
| Measure |
Non-Smokers
n=113 Participants
* Abstinent for at least 12 months from the use of any nicotine and/or tobacco-containing product based on self-reporting.
* Must not be exposed to tobacco or nicotine-containing products use in any other substantial way (family, partner, workplace, etc.).
|
Cigarette Smokers
n=42 Participants
* Used at least 100 cigarettes
* Smokes cigarettes daily \> 1/day
* Uses IQOS less than daily
* Uses less than 30 HeatSticks/month
* Cigarette is \> 95% of tobacco/nicotine product (all product use)
|
IQOS Passive Users (Not Using IQOS)
n=45 Participants
* Used at least 100 HeatSticks
* Uses IQOS daily \> 1/day
* Smokes a cigarette less than daily
* Smokes less than 30 cigarettes/month
* IQOS is \> 95% of tobacco/nicotine product (all product use)
* excluding other products (e-cig/Ploom/etc.)
|
IQOS Active Users (Using IQOS)
n=60 Participants
* 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.)
|
|---|---|---|---|---|
|
Total NNN: (Exposure Event)
Baseline
|
NA ng/g
Below the limit of quantification.
|
2.694 ng/g
Interval 1.843 to 3.939
|
1.753 ng/g
Interval 1.396 to 2.201
|
0.9088 ng/g
Interval 0.6614 to 1.249
|
|
Total NNN: (Exposure Event)
Final Void
|
NA ng/g
Below the limit of quantification.
|
3.992 ng/g
Interval 2.647 to 6.019
|
2.034 ng/g
Interval 1.333 to 3.104
|
2.347 ng/g
Interval 1.761 to 3.128
|
SECONDARY outcome
Timeframe: Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).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).
To measure 3-hydroxy-1-methylpropylmercapturic acid (HMPMA, a BoExp to Crotonaldehyde ) in spot urine (concentration adjusted for creatinine).
Outcome measures
| Measure |
Non-Smokers
n=77 Participants
* Abstinent for at least 12 months from the use of any nicotine and/or tobacco-containing product based on self-reporting.
* Must not be exposed to tobacco or nicotine-containing products use in any other substantial way (family, partner, workplace, etc.).
|
Cigarette Smokers
n=32 Participants
* Used at least 100 cigarettes
* Smokes cigarettes daily \> 1/day
* Uses IQOS less than daily
* Uses less than 30 HeatSticks/month
* Cigarette is \> 95% of tobacco/nicotine product (all product use)
|
IQOS Passive Users (Not Using IQOS)
n=32 Participants
* Used at least 100 HeatSticks
* Uses IQOS daily \> 1/day
* Smokes a cigarette less than daily
* Smokes less than 30 cigarettes/month
* IQOS is \> 95% of tobacco/nicotine product (all product use)
* excluding other products (e-cig/Ploom/etc.)
|
IQOS Active Users (Using IQOS)
* 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.)
|
|---|---|---|---|---|
|
HPMA (Non-Exposure Events)
Baseline
|
103.2 μg/g
Interval 87.58 to 121.7
|
318.6 μg/g
Interval 249.4 to 406.9
|
133.2 μg/g
Interval 94.67 to 187.4
|
—
|
|
HPMA (Non-Exposure Events)
Final void
|
232.6 μg/g
Interval 191.1 to 283.0
|
307.7 μg/g
Interval 227.9 to 415.4
|
211.9 μg/g
Interval 160.4 to 280.0
|
—
|
SECONDARY outcome
Timeframe: Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).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).
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.
Outcome measures
| Measure |
Non-Smokers
n=113 Participants
* Abstinent for at least 12 months from the use of any nicotine and/or tobacco-containing product based on self-reporting.
* Must not be exposed to tobacco or nicotine-containing products use in any other substantial way (family, partner, workplace, etc.).
|
Cigarette Smokers
n=42 Participants
* Used at least 100 cigarettes
* Smokes cigarettes daily \> 1/day
* Uses IQOS less than daily
* Uses less than 30 HeatSticks/month
* Cigarette is \> 95% of tobacco/nicotine product (all product use)
|
IQOS Passive Users (Not Using IQOS)
n=45 Participants
* Used at least 100 HeatSticks
* Uses IQOS daily \> 1/day
* Smokes a cigarette less than daily
* Smokes less than 30 cigarettes/month
* IQOS is \> 95% of tobacco/nicotine product (all product use)
* excluding other products (e-cig/Ploom/etc.)
|
IQOS Active Users (Using IQOS)
n=60 Participants
* 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.)
|
|---|---|---|---|---|
|
HPMA (Exposure Events)
Baseline
|
82.91 μg/g
Interval 74.36 to 92.44
|
233.4 μg/g
Interval 181.7 to 299.8
|
92.85 μg/g
Interval 82.83 to 104.1
|
103.0 μg/g
Interval 84.78 to 125.1
|
|
HPMA (Exposure Events)
Final void
|
170.9 μg/g
Interval 152.4 to 191.7
|
224.1 μg/g
Interval 186.3 to 269.5
|
166.7 μg/g
Interval 137.3 to 202.4
|
195.3 μg/g
Interval 165.3 to 230.7
|
SECONDARY outcome
Timeframe: Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).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).
To measure 3 hydroxypropylmercapturic acid (3-HPMA, a BoExp to Acrolein) in spot urine (concentration adjusted for creatinine).
Outcome measures
| Measure |
Non-Smokers
n=77 Participants
* Abstinent for at least 12 months from the use of any nicotine and/or tobacco-containing product based on self-reporting.
* Must not be exposed to tobacco or nicotine-containing products use in any other substantial way (family, partner, workplace, etc.).
|
Cigarette Smokers
n=32 Participants
* Used at least 100 cigarettes
* Smokes cigarettes daily \> 1/day
* Uses IQOS less than daily
* Uses less than 30 HeatSticks/month
* Cigarette is \> 95% of tobacco/nicotine product (all product use)
|
IQOS Passive Users (Not Using IQOS)
n=32 Participants
* Used at least 100 HeatSticks
* Uses IQOS daily \> 1/day
* Smokes a cigarette less than daily
* Smokes less than 30 cigarettes/month
* IQOS is \> 95% of tobacco/nicotine product (all product use)
* excluding other products (e-cig/Ploom/etc.)
|
IQOS Active Users (Using IQOS)
* 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.)
|
|---|---|---|---|---|
|
3-HPMA (Non-Exposure Events)
Baseline
|
242.1 μg/g
Interval 207.6 to 282.5
|
935.7 μg/g
Interval 742.2 to 1180.0
|
454.9 μg/g
Interval 356.0 to 581.3
|
—
|
|
3-HPMA (Non-Exposure Events)
Final Void
|
1108 μg/g
Interval 840.7 to 1461.0
|
1334 μg/g
Interval 950.9 to 1871.0
|
1240 μg/g
Interval 868.0 to 1771.0
|
—
|
SECONDARY outcome
Timeframe: Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).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).
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.
Outcome measures
| Measure |
Non-Smokers
n=113 Participants
* Abstinent for at least 12 months from the use of any nicotine and/or tobacco-containing product based on self-reporting.
* Must not be exposed to tobacco or nicotine-containing products use in any other substantial way (family, partner, workplace, etc.).
|
Cigarette Smokers
n=42 Participants
* Used at least 100 cigarettes
* Smokes cigarettes daily \> 1/day
* Uses IQOS less than daily
* Uses less than 30 HeatSticks/month
* Cigarette is \> 95% of tobacco/nicotine product (all product use)
|
IQOS Passive Users (Not Using IQOS)
n=45 Participants
* Used at least 100 HeatSticks
* Uses IQOS daily \> 1/day
* Smokes a cigarette less than daily
* Smokes less than 30 cigarettes/month
* IQOS is \> 95% of tobacco/nicotine product (all product use)
* excluding other products (e-cig/Ploom/etc.)
|
IQOS Active Users (Using IQOS)
n=60 Participants
* 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.)
|
|---|---|---|---|---|
|
3-HPMA (Exposure Events)
Baseline
|
246.6 μg/g
Interval 217.9 to 279.1
|
840.6 μg/g
Interval 666.2 to 1061.0
|
404.4 μg/g
Interval 338.6 to 483.0
|
381.1 μg/g
Interval 316.7 to 458.7
|
|
3-HPMA (Exposure Events)
Final Void
|
1982 μg/g
Interval 1681.0 to 2338.0
|
2051 μg/g
Interval 1561.0 to 2696.0
|
1938 μg/g
Interval 1488.0 to 2525.0
|
1729 μg/g
Interval 1368.0 to 2186.0
|
SECONDARY outcome
Timeframe: Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).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).
To measure S-phenylmercapturic acid (S-PMA, a BoExp to Benzene) in spot urine (concentration adjusted for creatinine).
Outcome measures
| Measure |
Non-Smokers
n=77 Participants
* Abstinent for at least 12 months from the use of any nicotine and/or tobacco-containing product based on self-reporting.
* Must not be exposed to tobacco or nicotine-containing products use in any other substantial way (family, partner, workplace, etc.).
|
Cigarette Smokers
n=32 Participants
* Used at least 100 cigarettes
* Smokes cigarettes daily \> 1/day
* Uses IQOS less than daily
* Uses less than 30 HeatSticks/month
* Cigarette is \> 95% of tobacco/nicotine product (all product use)
|
IQOS Passive Users (Not Using IQOS)
n=32 Participants
* Used at least 100 HeatSticks
* Uses IQOS daily \> 1/day
* Smokes a cigarette less than daily
* Smokes less than 30 cigarettes/month
* IQOS is \> 95% of tobacco/nicotine product (all product use)
* excluding other products (e-cig/Ploom/etc.)
|
IQOS Active Users (Using IQOS)
* 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.)
|
|---|---|---|---|---|
|
S-PMA (Non-Exposure Events)
Baseline
|
113.2 ng/g
Interval 96.8 to 132.4
|
1441 ng/g
Interval 904.4 to 2296.0
|
192.6 ng/g
Interval 128.0 to 289.0
|
—
|
|
S-PMA (Non-Exposure Events)
Final Void
|
132.0 ng/g
Interval 113.7 to 153.1
|
1023 ng/g
Interval 594.5 to 1761.0
|
201.3 ng/g
Interval 137.5 to 294.7
|
—
|
SECONDARY outcome
Timeframe: Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).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).
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.
Outcome measures
| Measure |
Non-Smokers
n=113 Participants
* Abstinent for at least 12 months from the use of any nicotine and/or tobacco-containing product based on self-reporting.
* Must not be exposed to tobacco or nicotine-containing products use in any other substantial way (family, partner, workplace, etc.).
|
Cigarette Smokers
n=42 Participants
* Used at least 100 cigarettes
* Smokes cigarettes daily \> 1/day
* Uses IQOS less than daily
* Uses less than 30 HeatSticks/month
* Cigarette is \> 95% of tobacco/nicotine product (all product use)
|
IQOS Passive Users (Not Using IQOS)
n=45 Participants
* Used at least 100 HeatSticks
* Uses IQOS daily \> 1/day
* Smokes a cigarette less than daily
* Smokes less than 30 cigarettes/month
* IQOS is \> 95% of tobacco/nicotine product (all product use)
* excluding other products (e-cig/Ploom/etc.)
|
IQOS Active Users (Using IQOS)
n=60 Participants
* 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.)
|
|---|---|---|---|---|
|
S-PMA (Exposure Events)
Baseline
|
123.5 ng/g
Interval 106.9 to 142.7
|
735.1 ng/g
Interval 482.9 to 1119.0
|
151.9 ng/g
Interval 116.9 to 197.5
|
195.3 ng/g
Interval 147.9 to 257.9
|
|
S-PMA (Exposure Events)
Final Void
|
136.9 ng/g
Interval 121.4 to 154.4
|
612.5 ng/g
Interval 415.0 to 904.2
|
156.7 ng/g
Interval 124.0 to 198.1
|
229.3 ng/g
Interval 173.9 to 302.3
|
SECONDARY outcome
Timeframe: Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).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).
To measure 2-hydroxyethyl mercapturic acid (HEMA, a BoExp to Ethylene Oxide) in spot urine (concentration adjusted for creatinine).
Outcome measures
| Measure |
Non-Smokers
n=77 Participants
* Abstinent for at least 12 months from the use of any nicotine and/or tobacco-containing product based on self-reporting.
* Must not be exposed to tobacco or nicotine-containing products use in any other substantial way (family, partner, workplace, etc.).
|
Cigarette Smokers
n=32 Participants
* Used at least 100 cigarettes
* Smokes cigarettes daily \> 1/day
* Uses IQOS less than daily
* Uses less than 30 HeatSticks/month
* Cigarette is \> 95% of tobacco/nicotine product (all product use)
|
IQOS Passive Users (Not Using IQOS)
n=32 Participants
* Used at least 100 HeatSticks
* Uses IQOS daily \> 1/day
* Smokes a cigarette less than daily
* Smokes less than 30 cigarettes/month
* IQOS is \> 95% of tobacco/nicotine product (all product use)
* excluding other products (e-cig/Ploom/etc.)
|
IQOS Active Users (Using IQOS)
* 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.)
|
|---|---|---|---|---|
|
HEMA (Non-Exposure Events)
Baseline
|
635.1 ng/g
Interval 540.3 to 746.5
|
1671 ng/g
Interval 1259.0 to 2217.0
|
629.1 ng/g
Interval 506.0 to 782.1
|
—
|
|
HEMA (Non-Exposure Events)
Final Void
|
1299 ng/g
Interval 1063.0 to 1588.0
|
2595 ng/g
Interval 1819.0 to 3701.0
|
1520 ng/g
Interval 1181.0 to 1956.0
|
—
|
SECONDARY outcome
Timeframe: Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).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).
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.
Outcome measures
| Measure |
Non-Smokers
n=113 Participants
* Abstinent for at least 12 months from the use of any nicotine and/or tobacco-containing product based on self-reporting.
* Must not be exposed to tobacco or nicotine-containing products use in any other substantial way (family, partner, workplace, etc.).
|
Cigarette Smokers
n=42 Participants
* Used at least 100 cigarettes
* Smokes cigarettes daily \> 1/day
* Uses IQOS less than daily
* Uses less than 30 HeatSticks/month
* Cigarette is \> 95% of tobacco/nicotine product (all product use)
|
IQOS Passive Users (Not Using IQOS)
n=45 Participants
* Used at least 100 HeatSticks
* Uses IQOS daily \> 1/day
* Smokes a cigarette less than daily
* Smokes less than 30 cigarettes/month
* IQOS is \> 95% of tobacco/nicotine product (all product use)
* excluding other products (e-cig/Ploom/etc.)
|
IQOS Active Users (Using IQOS)
n=60 Participants
* 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.)
|
|---|---|---|---|---|
|
HEMA (Exposure Events)
Baseline
|
651.3 ng/g
Interval 572.1 to 741.5
|
1143 ng/g
Interval 895.6 to 1458.0
|
675.0 ng/g
Interval 546.2 to 834.1
|
705.0 ng/g
Interval 593.0 to 838.0
|
|
HEMA (Exposure Events)
Final Void
|
1486 ng/g
Interval 1299.0 to 1699.0
|
1967 ng/g
Interval 1547.0 to 2501.0
|
1440 ng/g
Interval 1174.0 to 1768.0
|
1513 ng/g
Interval 1270.0 to 1801.0
|
SECONDARY outcome
Timeframe: Measured at baseline for up to 3h prior to start of the event, then continuously during the event until 3h after the last participant has entered the event for 1h.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.
Outcome measures
| Measure |
Non-Smokers
n=141 Participants
* Abstinent for at least 12 months from the use of any nicotine and/or tobacco-containing product based on self-reporting.
* Must not be exposed to tobacco or nicotine-containing products use in any other substantial way (family, partner, workplace, etc.).
|
Cigarette Smokers
n=260 Participants
* Used at least 100 cigarettes
* Smokes cigarettes daily \> 1/day
* Uses IQOS less than daily
* Uses less than 30 HeatSticks/month
* Cigarette is \> 95% of tobacco/nicotine product (all product use)
|
IQOS Passive Users (Not Using IQOS)
* Used at least 100 HeatSticks
* Uses IQOS daily \> 1/day
* Smokes a cigarette less than daily
* Smokes less than 30 cigarettes/month
* IQOS is \> 95% of tobacco/nicotine product (all product use)
* excluding other products (e-cig/Ploom/etc.)
|
IQOS Active Users (Using IQOS)
* 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.)
|
|---|---|---|---|---|
|
3-Ethenylpyridine (3-EP) [µg/m^3]
Prior to Event
|
NA µg/m^3
Below the limit of detection.
|
NA µg/m^3
Below the limit of detection.
|
—
|
—
|
|
3-Ethenylpyridine (3-EP) [µg/m^3]
End of Event
|
NA µg/m^3
Below the limit of detection.
|
NA µg/m^3
Below the limit of detection.
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured at baseline for up to 3h prior to start of the event, then continuously during the event until 3h after the last participant has entered the event for 1h.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)
Outcome measures
| Measure |
Non-Smokers
n=141 Participants
* Abstinent for at least 12 months from the use of any nicotine and/or tobacco-containing product based on self-reporting.
* Must not be exposed to tobacco or nicotine-containing products use in any other substantial way (family, partner, workplace, etc.).
|
Cigarette Smokers
n=260 Participants
* Used at least 100 cigarettes
* Smokes cigarettes daily \> 1/day
* Uses IQOS less than daily
* Uses less than 30 HeatSticks/month
* Cigarette is \> 95% of tobacco/nicotine product (all product use)
|
IQOS Passive Users (Not Using IQOS)
* Used at least 100 HeatSticks
* Uses IQOS daily \> 1/day
* Smokes a cigarette less than daily
* Smokes less than 30 cigarettes/month
* IQOS is \> 95% of tobacco/nicotine product (all product use)
* excluding other products (e-cig/Ploom/etc.)
|
IQOS Active Users (Using IQOS)
* 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.)
|
|---|---|---|---|---|
|
Nicotine [µg/m^3]
Prior to Event
|
NA µg/m^3
Below the limit of detection.
|
NA µg/m^3
Below the limit of detection.
|
—
|
—
|
|
Nicotine [µg/m^3]
End of Event
|
NA µg/m^3
Below the limit of detection.
|
0.9776 µg/m^3
Interval 0.8105 to 1.179
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured at baseline for up to 3h prior to start of the event, then continuously during the event until 3h after the last participant has entered the event for 1h.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)
Outcome measures
| Measure |
Non-Smokers
n=141 Participants
* Abstinent for at least 12 months from the use of any nicotine and/or tobacco-containing product based on self-reporting.
* Must not be exposed to tobacco or nicotine-containing products use in any other substantial way (family, partner, workplace, etc.).
|
Cigarette Smokers
n=260 Participants
* Used at least 100 cigarettes
* Smokes cigarettes daily \> 1/day
* Uses IQOS less than daily
* Uses less than 30 HeatSticks/month
* Cigarette is \> 95% of tobacco/nicotine product (all product use)
|
IQOS Passive Users (Not Using IQOS)
* Used at least 100 HeatSticks
* Uses IQOS daily \> 1/day
* Smokes a cigarette less than daily
* Smokes less than 30 cigarettes/month
* IQOS is \> 95% of tobacco/nicotine product (all product use)
* excluding other products (e-cig/Ploom/etc.)
|
IQOS Active Users (Using IQOS)
* 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.)
|
|---|---|---|---|---|
|
Acetaldehyde [µg/m^3]
Prior to Event
|
16.52 µg/m^3
Interval 15.5 to 17.6
|
29.20 µg/m^3
Interval 26.02 to 32.78
|
—
|
—
|
|
Acetaldehyde [µg/m^3]
End of Event
|
110 µg/m^3
Interval 91.12 to 132.8
|
187.4 µg/m^3
Interval 168.9 to 207.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured at baseline for up to 3h prior to start of the event, then continuously during the event until 3h after the last participant has entered the event for 1h.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)
Outcome measures
| Measure |
Non-Smokers
n=141 Participants
* Abstinent for at least 12 months from the use of any nicotine and/or tobacco-containing product based on self-reporting.
* Must not be exposed to tobacco or nicotine-containing products use in any other substantial way (family, partner, workplace, etc.).
|
Cigarette Smokers
n=260 Participants
* Used at least 100 cigarettes
* Smokes cigarettes daily \> 1/day
* Uses IQOS less than daily
* Uses less than 30 HeatSticks/month
* Cigarette is \> 95% of tobacco/nicotine product (all product use)
|
IQOS Passive Users (Not Using IQOS)
* Used at least 100 HeatSticks
* Uses IQOS daily \> 1/day
* Smokes a cigarette less than daily
* Smokes less than 30 cigarettes/month
* IQOS is \> 95% of tobacco/nicotine product (all product use)
* excluding other products (e-cig/Ploom/etc.)
|
IQOS Active Users (Using IQOS)
* 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.)
|
|---|---|---|---|---|
|
Acrolein [µg/m^3]
Prior to Event
|
0.03291 µg/m^3
Interval 0.02976 to 0.03639
|
0.07646 µg/m^3
Interval 0.06749 to 0.08662
|
—
|
—
|
|
Acrolein [µg/m^3]
End of Event
|
0.07368 µg/m^3
Interval 0.05514 to 0.09845
|
0.3288 µg/m^3
Interval 0.2841 to 0.3805
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured at baseline for up to 3h prior to start of the event, then continuously during the event until 3h after the last participant has entered the event for 1h.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)
Outcome measures
| Measure |
Non-Smokers
n=141 Participants
* Abstinent for at least 12 months from the use of any nicotine and/or tobacco-containing product based on self-reporting.
* Must not be exposed to tobacco or nicotine-containing products use in any other substantial way (family, partner, workplace, etc.).
|
Cigarette Smokers
n=260 Participants
* Used at least 100 cigarettes
* Smokes cigarettes daily \> 1/day
* Uses IQOS less than daily
* Uses less than 30 HeatSticks/month
* Cigarette is \> 95% of tobacco/nicotine product (all product use)
|
IQOS Passive Users (Not Using IQOS)
* Used at least 100 HeatSticks
* Uses IQOS daily \> 1/day
* Smokes a cigarette less than daily
* Smokes less than 30 cigarettes/month
* IQOS is \> 95% of tobacco/nicotine product (all product use)
* excluding other products (e-cig/Ploom/etc.)
|
IQOS Active Users (Using IQOS)
* 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.)
|
|---|---|---|---|---|
|
Crotonaldehyde [µg/m^3]
Prior to Event
|
0.07621 µg/m^3
Interval 0.07024 to 0.08269
|
0.09775 µg/m^3
Interval 0.09048 to 0.1056
|
—
|
—
|
|
Crotonaldehyde [µg/m^3]
End of Event
|
0.1356 µg/m^3
Interval 0.1167 to 0.1577
|
0.2523 µg/m^3
Interval 0.2335 to 0.2726
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured at baseline for up to 3h prior to start of the event, then continuously during the event until 3h after the last participant has entered the event for 1h.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)
Outcome measures
| Measure |
Non-Smokers
n=141 Participants
* Abstinent for at least 12 months from the use of any nicotine and/or tobacco-containing product based on self-reporting.
* Must not be exposed to tobacco or nicotine-containing products use in any other substantial way (family, partner, workplace, etc.).
|
Cigarette Smokers
n=260 Participants
* Used at least 100 cigarettes
* Smokes cigarettes daily \> 1/day
* Uses IQOS less than daily
* Uses less than 30 HeatSticks/month
* Cigarette is \> 95% of tobacco/nicotine product (all product use)
|
IQOS Passive Users (Not Using IQOS)
* Used at least 100 HeatSticks
* Uses IQOS daily \> 1/day
* Smokes a cigarette less than daily
* Smokes less than 30 cigarettes/month
* IQOS is \> 95% of tobacco/nicotine product (all product use)
* excluding other products (e-cig/Ploom/etc.)
|
IQOS Active Users (Using IQOS)
* 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.)
|
|---|---|---|---|---|
|
Formaldehyde [µg/m^3]
Prior to Event
|
16.60 µg/m^3
Interval 15.42 to 17.87
|
17.15 µg/m^3
Interval 16.2 to 18.16
|
—
|
—
|
|
Formaldehyde [µg/m^3]
End of Event
|
17.49 µg/m^3
Interval 16.59 to 18.45
|
22.74 µg/m^3
Interval 21.84 to 23.67
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured at baseline for up to 3h prior to start of the event, then continuously during the event until 3h after the last participant has entered the event for 1h.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.
Outcome measures
| Measure |
Non-Smokers
n=141 Participants
* Abstinent for at least 12 months from the use of any nicotine and/or tobacco-containing product based on self-reporting.
* Must not be exposed to tobacco or nicotine-containing products use in any other substantial way (family, partner, workplace, etc.).
|
Cigarette Smokers
n=260 Participants
* Used at least 100 cigarettes
* Smokes cigarettes daily \> 1/day
* Uses IQOS less than daily
* Uses less than 30 HeatSticks/month
* Cigarette is \> 95% of tobacco/nicotine product (all product use)
|
IQOS Passive Users (Not Using IQOS)
* Used at least 100 HeatSticks
* Uses IQOS daily \> 1/day
* Smokes a cigarette less than daily
* Smokes less than 30 cigarettes/month
* IQOS is \> 95% of tobacco/nicotine product (all product use)
* excluding other products (e-cig/Ploom/etc.)
|
IQOS Active Users (Using IQOS)
* 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.)
|
|---|---|---|---|---|
|
NNN [µg/m^3]
Prior to Event
|
NA µg/m^3
Below the limit of detection.
|
NA µg/m^3
Below the limit of detection.
|
—
|
—
|
|
NNN [µg/m^3]
End of Event
|
NA µg/m^3
Below the limit of detection.
|
NA µg/m^3
Below the limit of detection.
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured at baseline for up to 3h prior to start of the event, then continuously during the event until 3h after the last participant has entered the event for 1h.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.
Outcome measures
| Measure |
Non-Smokers
n=141 Participants
* Abstinent for at least 12 months from the use of any nicotine and/or tobacco-containing product based on self-reporting.
* Must not be exposed to tobacco or nicotine-containing products use in any other substantial way (family, partner, workplace, etc.).
|
Cigarette Smokers
n=260 Participants
* Used at least 100 cigarettes
* Smokes cigarettes daily \> 1/day
* Uses IQOS less than daily
* Uses less than 30 HeatSticks/month
* Cigarette is \> 95% of tobacco/nicotine product (all product use)
|
IQOS Passive Users (Not Using IQOS)
* Used at least 100 HeatSticks
* Uses IQOS daily \> 1/day
* Smokes a cigarette less than daily
* Smokes less than 30 cigarettes/month
* IQOS is \> 95% of tobacco/nicotine product (all product use)
* excluding other products (e-cig/Ploom/etc.)
|
IQOS Active Users (Using IQOS)
* 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.)
|
|---|---|---|---|---|
|
NNK [µg/m^3]
Prior to Event
|
NA µg/m^3
Below the limit of detection.
|
NA µg/m^3
Below the limit of detection.
|
—
|
—
|
|
NNK [µg/m^3]
End of Event
|
NA µg/m^3
Below the limit of detection.
|
NA µg/m^3
Below the limit of detection.
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured at baseline for up to 3h prior to start of the event, then continuously during the event until 3h after the last participant has entered the event for 1h.Real-time measurements of PM1 suspended particles in air. (ISO Norm 18144:2003)
Outcome measures
| Measure |
Non-Smokers
n=141 Participants
* Abstinent for at least 12 months from the use of any nicotine and/or tobacco-containing product based on self-reporting.
* Must not be exposed to tobacco or nicotine-containing products use in any other substantial way (family, partner, workplace, etc.).
|
Cigarette Smokers
n=260 Participants
* Used at least 100 cigarettes
* Smokes cigarettes daily \> 1/day
* Uses IQOS less than daily
* Uses less than 30 HeatSticks/month
* Cigarette is \> 95% of tobacco/nicotine product (all product use)
|
IQOS Passive Users (Not Using IQOS)
* Used at least 100 HeatSticks
* Uses IQOS daily \> 1/day
* Smokes a cigarette less than daily
* Smokes less than 30 cigarettes/month
* IQOS is \> 95% of tobacco/nicotine product (all product use)
* excluding other products (e-cig/Ploom/etc.)
|
IQOS Active Users (Using IQOS)
* 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.)
|
|---|---|---|---|---|
|
PM1 Particles [µg/m^3]
Prior to Event
|
1.489 µg/m^3
Interval 1.367 to 1.611
|
1.251 µg/m^3
Interval 1.15 to 1.353
|
—
|
—
|
|
PM1 Particles [µg/m^3]
End of Event
|
11.508 µg/m^3
Interval 10.535 to 12.48
|
9.991 µg/m^3
Interval 9.658 to 10.325
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured at baseline for up to 3h prior to start of the event, then continuously during the event until 3h after the last participant has entered the event for 1h.Real-time measurements of PM2.5 suspended particles in air. (ISO Norm 18144:2003)
Outcome measures
| Measure |
Non-Smokers
n=141 Participants
* Abstinent for at least 12 months from the use of any nicotine and/or tobacco-containing product based on self-reporting.
* Must not be exposed to tobacco or nicotine-containing products use in any other substantial way (family, partner, workplace, etc.).
|
Cigarette Smokers
n=260 Participants
* Used at least 100 cigarettes
* Smokes cigarettes daily \> 1/day
* Uses IQOS less than daily
* Uses less than 30 HeatSticks/month
* Cigarette is \> 95% of tobacco/nicotine product (all product use)
|
IQOS Passive Users (Not Using IQOS)
* Used at least 100 HeatSticks
* Uses IQOS daily \> 1/day
* Smokes a cigarette less than daily
* Smokes less than 30 cigarettes/month
* IQOS is \> 95% of tobacco/nicotine product (all product use)
* excluding other products (e-cig/Ploom/etc.)
|
IQOS Active Users (Using IQOS)
* 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.)
|
|---|---|---|---|---|
|
PM2.5 Particles [µg/m^3]
Prior to Event
|
1.585 µg/m^3
Interval 1.46 to 1.71
|
1.340 µg/m^3
Interval 1.239 to 1.441
|
—
|
—
|
|
PM2.5 Particles [µg/m^3]
End of Event
|
12.648 µg/m^3
Interval 11.568 to 13.72
|
10.755 µg/m^3
Interval 10.405 to 11.1
|
—
|
—
|
Adverse Events
Non-Smokers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cigarette Smokers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
IQOS Passive Users (Not Using IQOS)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
IQOS Active Users (Using IQOS)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Christelle Haziza, Director Health Science and Biostatistics
Philip Morris Products S.A.
Phone: +41 58 242 11 11
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER