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Real-Life Passive Exposure Assessment of IQOS

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ClinicalTrials.gov Identifier: NCT03550989
Recruitment Status : Completed
First Posted : June 11, 2018
Results First Posted : July 29, 2019
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Philip Morris Products S.A.

Study Type Observational
Study Design Observational Model: Other;   Time Perspective: Other
Condition Environmental Exposure
Interventions Other: Non-Exposure Event
Other: Exposure Event
Enrollment 401
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Non-Smokers Cigarette Smokers IQOS Passive Users (Not Using IQOS) IQOS Active Users (Using IQOS)
Hide Arm/Group Description

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).

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).

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).

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).

Period Title: Overall Study
Started 190 74 77 60
Completed 188 73 76 60
Not Completed 2 1 1 0
Arm/Group Title Non-Smokers Cigarette Smokers IQOS Passive Users (Not Using IQOS) IQOS Active Users (Using IQOS) Total
Hide Arm/Group Description
  • 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.).
  • 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)
  • 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.)
  • 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 of all reporting groups
Overall Number of Baseline Participants 190 74 77 60 401
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 190 participants 74 participants 77 participants 60 participants 401 participants
44.3  (12.52) 49.9  (14.40) 43.6  (11.08) 38.8  (11.00) 44.4  (12.79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 190 participants 74 participants 77 participants 60 participants 401 participants
Female
77
  40.5%
10
  13.5%
21
  27.3%
13
  21.7%
121
  30.2%
Male
113
  59.5%
64
  86.5%
56
  72.7%
47
  78.3%
280
  69.8%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Japanese Origin Number Analyzed 190 participants 74 participants 77 participants 60 participants 401 participants
190
 100.0%
74
 100.0%
77
 100.0%
60
 100.0%
401
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 190 participants 74 participants 77 participants 60 participants 401 participants
190 74 77 60 401
1.Primary Outcome
Title NEQ: (Non-Exposure Event)
Hide Description To measure nicotine equivalents (NEQ, a biomarker of exposure to Nicotine): molar sum of free nicotine, nicotine-glucuronide, free cotinine, cotinine-glucuronide, free trans-3'-hydroxycotinine, trans-3'-hydroxycotinine-glucuronide in spot urine (expressed as concentration adjusted to creatinine).
Time Frame Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).
Hide Outcome Measure Data
Hide Analysis Population Description
Some participants were excluded from analysis for protocol deviations (including but not limited to, missing questionnaires, attended events but was not eligible to attend, assigned to an incorrect group, or missing samples).
Arm/Group Title Non-Smokers Cigarette Smokers IQOS Passive Users (Not Using IQOS)
Hide Arm/Group Description:
  • 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.).
  • 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)
  • 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.)
Overall Number of Participants Analyzed 77 32 32
Geometric Mean (95% Confidence Interval)
Unit of Measure: mg/g
Baseline Number Analyzed 70 participants 27 participants 27 participants
0.03845
(0.03120 to 0.04739)
4.159
(2.253 to 7.678)
5.695
(4.286 to 7.567)
Final void Number Analyzed 73 participants 30 participants 31 participants
0.06876
(0.05527 to 0.08553)
5.175
(2.902 to 9.228)
6.821
(5.127 to 9.074)
2.Primary Outcome
Title NEQ: (Exposure Event)
Hide Description To measure nicotine equivalents (NEQ, a biomarker of exposure to Nicotine): molar sum of free nicotine, nicotine-glucuronide, free cotinine, cotinine-glucuronide, free trans-3'-hydroxycotinine, trans-3'-hydroxycotinine-glucuronide in spot urine (expressed as concentration adjusted to creatinine), during exposure events where some subjects used IQOS.
Time Frame Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).
Hide Outcome Measure Data
Hide Analysis Population Description
Some participants were excluded from analysis for protocol deviations (including but not limited to, missing questionnaires, attended events but was not eligible to attend, assigned to an incorrect group, or missing samples).
Arm/Group Title Non-Smokers Cigarette Smokers IQOS Passive Users (Not Using IQOS) IQOS Active Users (Using IQOS)
Hide Arm/Group Description:
  • 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.).
  • 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)
  • 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.)
  • 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.)
Overall Number of Participants Analyzed 113 42 45 60
Geometric Mean (95% Confidence Interval)
Unit of Measure: mg/g
Baseline Number Analyzed 112 participants 38 participants 44 participants 59 participants
0.04078
(0.03397 to 0.04896)
3.051
(1.720 to 5.414)
5.277
(4.018 to 6.930)
4.683
(3.553 to 6.171)
Final void Number Analyzed 112 participants 42 participants 45 participants 60 participants
0.06205
(0.05000 to 0.07700)
2.889
(1.573 to 5.308)
5.974
(4.696 to 7.598)
8.499
(6.667 to 10.83)
3.Primary Outcome
Title Total NNAL: (Non-Exposure Event)
Hide Description To measure Total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL, a BoExp to Tobacco Specific Nitrosamines) in spot urine (expressed as concentration adjusted to creatinine).
Time Frame Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).
Hide Outcome Measure Data
Hide Analysis Population Description
Some participants were excluded from analysis for protocol deviations (including but not limited to, missing questionnaires, attended events but was not eligible to attend, assigned to an incorrect group, or missing samples).
Arm/Group Title Non-Smokers Cigarette Smokers IQOS Passive Users (Not Using IQOS)
Hide Arm/Group Description:
  • 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.).
  • 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)
  • 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.)
Overall Number of Participants Analyzed 77 32 32
Geometric Mean (95% Confidence Interval)
Unit of Measure: ng/g
Baseline Number Analyzed 74 participants 27 participants 28 participants
NA [1] 
(NA to NA)
69.65
(46.62 to 104.0)
20.55
(13.91 to 30.36)
Final Void Number Analyzed 75 participants 26 participants 31 participants
NA [1] 
(NA to NA)
81.64
(59.48 to 112.1)
27.41
(18.88 to 39.80)
[1]
Below the limit of quantification.
4.Primary Outcome
Title Total NNAL: (Exposure Event)
Hide Description To measure Total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL, a BoExp to Tobacco Specific Nitrosamines) in spot urine (expressed as concentration adjusted to creatinine), during exposure events where some subjects used IQOS.
Time Frame Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).
Hide Outcome Measure Data
Hide Analysis Population Description
Some participants were excluded from analysis for protocol deviations (including but not limited to, missing questionnaires, attended events but was not eligible to attend, assigned to an incorrect group, or missing samples).
Arm/Group Title Non-Smokers Cigarette Smokers IQOS Passive Users (Not Using IQOS) IQOS Active Users (Using IQOS)
Hide Arm/Group Description:
  • 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.).
  • 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)
  • 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.)
  • 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.)
Overall Number of Participants Analyzed 113 42 45 60
Geometric Mean (95% Confidence Interval)
Unit of Measure: ng/g
Baseline Number Analyzed 113 participants 38 participants 44 participants 59 participants
NA [1] 
(NA to NA)
48.57
(34.57 to 68.25)
19.68
(15.78 to 24.56)
21.50
(16.29 to 28.38)
Final Void Number Analyzed 113 participants 42 participants 45 participants 58 participants
NA [1] 
(NA to NA)
58.74
(45.76 to 75.39)
20.31
(15.83 to 26.06)
30.45
(23.91 to 38.77)
[1]
Below the limit of quantification.
5.Primary Outcome
Title Total NNN: (Non-Exposure Event)
Hide Description To measure Total N-nitrosonornicotine (Total NNN, a BoExp to Tobacco Specific Nitrosamines) in spot urine (expressed as concentration adjusted to creatinine).
Time Frame Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).
Hide Outcome Measure Data
Hide Analysis Population Description
Some participants were excluded from analysis for protocol deviations (including but not limited to, missing questionnaires, attended events but was not eligible to attend, assigned to an incorrect group, or missing samples).
Arm/Group Title Non-Smokers Cigarette Smokers IQOS Passive Users (Not Using IQOS)
Hide Arm/Group Description:
  • 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.).
  • 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)
  • 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.)
Overall Number of Participants Analyzed 77 32 32
Geometric Mean (95% Confidence Interval)
Unit of Measure: ng/g
Baseline Number Analyzed 74 participants 27 participants 27 participants
NA [1] 
(NA to NA)
3.945
(2.885 to 5.392)
1.493
(0.9808 to 2.272)
Final Void Number Analyzed 75 participants 25 participants 29 participants
NA [1] 
(NA to NA)
4.008
(2.395 to 6.708)
3.093
(1.826 to 5.240)
[1]
Below the limit of quantification.
6.Primary Outcome
Title Total NNN: (Exposure Event)
Hide Description To measure Total N-nitrosonornicotine (Total NNN, a BoExp to Tobacco Specific Nitrosamines) in spot urine (expressed as concentration adjusted to creatinine) during exposure events where some subjects used IQOS.
Time Frame Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).
Hide Outcome Measure Data
Hide Analysis Population Description
Some participants were excluded from analysis for protocol deviations (including but not limited to, missing questionnaires, attended events but was not eligible to attend, assigned to an incorrect group, or missing samples).
Arm/Group Title Non-Smokers Cigarette Smokers IQOS Passive Users (Not Using IQOS) IQOS Active Users (Using IQOS)
Hide Arm/Group Description:

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.).

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)
  • 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.)
  • 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.)
Overall Number of Participants Analyzed 113 42 45 60
Geometric Mean (95% Confidence Interval)
Unit of Measure: ng/g
Baseline Number Analyzed 112 participants 38 participants 44 participants 58 participants
NA [1] 
(NA to NA)
2.694
(1.843 to 3.939)
1.753
(1.396 to 2.201)
0.9088
(0.6614 to 1.249)
Final Void Number Analyzed 113 participants 42 participants 45 participants 56 participants
NA [1] 
(NA to NA)
3.992
(2.647 to 6.019)
2.034
(1.333 to 3.104)
2.347
(1.761 to 3.128)
[1]
Below the limit of quantification.
7.Secondary Outcome
Title HPMA (Non-Exposure Events)
Hide Description To measure 3-hydroxy-1-methylpropylmercapturic acid (HMPMA, a BoExp to Crotonaldehyde ) in spot urine (concentration adjusted for creatinine).
Time Frame Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).
Hide Outcome Measure Data
Hide Analysis Population Description
Some participants were excluded from analysis for protocol deviations (including but not limited to, missing questionnaires, attended events but was not eligible to attend, assigned to an incorrect group, or missing samples).
Arm/Group Title Non-Smokers Cigarette Smokers IQOS Passive Users (Not Using IQOS)
Hide Arm/Group Description:
  • 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.).
  • 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)
  • 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.)
Overall Number of Participants Analyzed 77 32 32
Geometric Mean (95% Confidence Interval)
Unit of Measure: μg/g
Baseline Number Analyzed 70 participants 27 participants 27 participants
103.2
(87.58 to 121.7)
318.6
(249.4 to 406.9)
133.2
(94.67 to 187.4)
Final void Number Analyzed 71 participants 22 participants 30 participants
232.6
(191.1 to 283.0)
307.7
(227.9 to 415.4)
211.9
(160.4 to 280.0)
8.Secondary Outcome
Title HPMA (Exposure Events)
Hide Description To measure 3-hydroxy-1-methylpropylmercapturic acid (HMPMA, a BoExp to Crotonaldehyde ) in spot urine (concentration adjusted for creatinine), during exposure events where some subjects used IQOS.
Time Frame Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).
Hide Outcome Measure Data
Hide Analysis Population Description
Some participants were excluded from analysis for protocol deviations (including but not limited to, missing questionnaires, attended events but was not eligible to attend, assigned to an incorrect group, or missing samples).
Arm/Group Title Non-Smokers Cigarette Smokers IQOS Passive Users (Not Using IQOS) IQOS Active Users (Using IQOS)
Hide Arm/Group Description:
  • 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.).
  • 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)
  • 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.)
  • 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.)
Overall Number of Participants Analyzed 113 42 45 60
Geometric Mean (95% Confidence Interval)
Unit of Measure: μg/g
Baseline Number Analyzed 112 participants 38 participants 43 participants 59 participants
82.91
(74.36 to 92.44)
233.4
(181.7 to 299.8)
92.85
(82.83 to 104.1)
103.0
(84.78 to 125.1)
Final void Number Analyzed 107 participants 41 participants 44 participants 57 participants
170.9
(152.4 to 191.7)
224.1
(186.3 to 269.5)
166.7
(137.3 to 202.4)
195.3
(165.3 to 230.7)
9.Secondary Outcome
Title 3-HPMA (Non-Exposure Events)
Hide Description To measure 3 hydroxypropylmercapturic acid (3-HPMA, a BoExp to Acrolein) in spot urine (concentration adjusted for creatinine).
Time Frame Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).
Hide Outcome Measure Data
Hide Analysis Population Description
Some participants were excluded from analysis for protocol deviations (including but not limited to, missing questionnaires, attended events but was not eligible to attend, assigned to an incorrect group, or missing samples).
Arm/Group Title Non-Smokers Cigarette Smokers IQOS Passive Users (Not Using IQOS)
Hide Arm/Group Description:
  • 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.).
  • 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)
  • 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.)
Overall Number of Participants Analyzed 77 32 32
Geometric Mean (95% Confidence Interval)
Unit of Measure: μg/g
Baseline Number Analyzed 70 participants 27 participants 27 participants
242.1
(207.6 to 282.5)
935.7
(742.2 to 1180)
454.9
(356.0 to 581.3)
Final Void Number Analyzed 70 participants 22 participants 29 participants
1108
(840.7 to 1461)
1334
(950.9 to 1871)
1240
(868.0 to 1771)
10.Secondary Outcome
Title 3-HPMA (Exposure Events)
Hide Description To measure 3 hydroxypropylmercapturic acid (3-HPMA, a BoExp to Acrolein) in spot urine (concentration adjusted for creatinine), during exposure events where some subjects used IQOS.
Time Frame Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).
Hide Outcome Measure Data
Hide Analysis Population Description
Some participants were excluded from analysis for protocol deviations (including but not limited to, missing questionnaires, attended events but was not eligible to attend, assigned to an incorrect group, or missing samples).
Arm/Group Title Non-Smokers Cigarette Smokers IQOS Passive Users (Not Using IQOS) IQOS Active Users (Using IQOS)
Hide Arm/Group Description:
  • 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.).
  • 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)
  • 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.)
  • 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.)
Overall Number of Participants Analyzed 113 42 45 60
Geometric Mean (95% Confidence Interval)
Unit of Measure: μg/g
Baseline Number Analyzed 112 participants 38 participants 43 participants 59 participants
246.6
(217.9 to 279.1)
840.6
(666.2 to 1061)
404.4
(338.6 to 483.0)
381.1
(316.7 to 458.7)
Final Void Number Analyzed 105 participants 41 participants 44 participants 56 participants
1982
(1681 to 2338)
2051
(1561 to 2696)
1938
(1488 to 2525)
1729
(1368 to 2186)
11.Secondary Outcome
Title S-PMA (Non-Exposure Events)
Hide Description To measure S-phenylmercapturic acid (S-PMA, a BoExp to Benzene) in spot urine (concentration adjusted for creatinine).
Time Frame Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).
Hide Outcome Measure Data
Hide Analysis Population Description
Some participants were excluded from analysis for protocol deviations (including but not limited to, missing questionnaires, attended events but was not eligible to attend, assigned to an incorrect group, or missing samples).
Arm/Group Title Non-Smokers Cigarette Smokers IQOS Passive Users (Not Using IQOS)
Hide Arm/Group Description:
  • 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.).
  • 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)
  • 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.)
Overall Number of Participants Analyzed 77 32 32
Geometric Mean (95% Confidence Interval)
Unit of Measure: ng/g
Baseline Number Analyzed 70 participants 27 participants 27 participants
113.2
(96.80 to 132.4)
1441
(904.4 to 2296)
192.6
(128.0 to 289.0)
Final Void Number Analyzed 71 participants 22 participants 31 participants
132.0
(113.7 to 153.1)
1023
(594.5 to 1761)
201.3
(137.5 to 294.7)
12.Secondary Outcome
Title S-PMA (Exposure Events)
Hide Description To measure S-phenylmercapturic acid (S-PMA, a BoExp to Benzene ) in spot urine (concentration adjusted for creatinine), during exposure events where some subjects used IQOS.
Time Frame Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).
Hide Outcome Measure Data
Hide Analysis Population Description
Some participants were excluded from analysis for protocol deviations (including but not limited to, missing questionnaires, attended events but was not eligible to attend, assigned to an incorrect group, or missing samples).
Arm/Group Title Non-Smokers Cigarette Smokers IQOS Passive Users (Not Using IQOS) IQOS Active Users (Using IQOS)
Hide Arm/Group Description:
  • 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.).
  • 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)
  • 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.)
  • 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.)
Overall Number of Participants Analyzed 113 42 45 60
Geometric Mean (95% Confidence Interval)
Unit of Measure: ng/g
Baseline Number Analyzed 112 participants 38 participants 43 participants 59 participants
123.5
(106.9 to 142.7)
735.1
(482.9 to 1119)
151.9
(116.9 to 197.5)
195.3
(147.9 to 257.9)
Final Void Number Analyzed 111 participants 41 participants 44 participants 58 participants
136.9
(121.4 to 154.4)
612.5
(415.0 to 904.2)
156.7
(124.0 to 198.1)
229.3
(173.9 to 302.3)
13.Secondary Outcome
Title HEMA (Non-Exposure Events)
Hide Description To measure 2-hydroxyethyl mercapturic acid (HEMA, a BoExp to Ethylene Oxide) in spot urine (concentration adjusted for creatinine).
Time Frame Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).
Hide Outcome Measure Data
Hide Analysis Population Description
Some participants were excluded from analysis for protocol deviations (including but not limited to, missing questionnaires, attended events but was not eligible to attend, assigned to an incorrect group, or missing samples).
Arm/Group Title Non-Smokers Cigarette Smokers IQOS Passive Users (Not Using IQOS)
Hide Arm/Group Description:
  • 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.).
  • 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)
  • 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.)
Overall Number of Participants Analyzed 77 32 32
Geometric Mean (95% Confidence Interval)
Unit of Measure: ng/g
Baseline Number Analyzed 70 participants 27 participants 27 participants
635.1
(540.3 to 746.5)
1671
(1259 to 2217)
629.1
(506.0 to 782.1)
Final Void Number Analyzed 70 participants 22 participants 29 participants
1299
(1063 to 1588)
2595
(1819 to 3701)
1520
(1181 to 1956)
14.Secondary Outcome
Title HEMA (Exposure Events)
Hide Description To measure 2-hydroxyethyl mercapturic acid (HEMA, a BoExp to Ethylene Oxide) in spot urine (concentration adjusted for creatinine), during exposure events where some subjects used IQOS.
Time Frame Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).
Hide Outcome Measure Data
Hide Analysis Population Description
Some participants were excluded from analysis for protocol deviations (including but not limited to, missing questionnaires, attended events but was not eligible to attend, assigned to an incorrect group, or missing samples).
Arm/Group Title Non-Smokers Cigarette Smokers IQOS Passive Users (Not Using IQOS) IQOS Active Users (Using IQOS)
Hide Arm/Group Description:
  • 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.).
  • 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)
  • 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.)
  • 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.)
Overall Number of Participants Analyzed 113 42 45 60
Geometric Mean (95% Confidence Interval)
Unit of Measure: ng/g
Baseline Number Analyzed 112 participants 38 participants 43 participants 59 participants
651.3
(572.1 to 741.5)
1143
(895.6 to 1458)
675.0
(546.2 to 834.1)
705.0
(593.0 to 838.0)
Final Void Number Analyzed 105 participants 41 participants 44 participants 56 participants
1486
(1299 to 1699)
1967
(1547 to 2501)
1440
(1174 to 1768)
1513
(1270 to 1801)
15.Secondary Outcome
Title 3-Ethenylpyridine (3-EP) [µg/m^3]
Hide Description

To measure IAQ, in real-time, through the assessment of concentrations of nicotine and select HPHCs representative of ETS in the air of the study site. (ISO Norm 18144:2003)

Note that the measurements of 3-EP [µg/m^3] were below the limit of detection.

Time Frame Measured at baseline for up to 3h prior to start of the event, then continuously during the event until 3h after the last participant has entered the event for 1h.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non-Exposure Event Exposure Event
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 141 260
Measure Type: Number
Unit of Measure: µg/m^3
Prior to Event NA [1]  NA [1] 
End of Event NA [1]  NA [1] 
[1]
Below the limit of detection.
16.Secondary Outcome
Title Nicotine [µg/m^3]
Hide Description To measure IAQ, in real-time, through the assessment of concentrations of nicotine and select HPHCs representative of ETS in the air of the study site. (ISO Norm 18144:2003)
Time Frame Measured at baseline for up to 3h prior to start of the event, then continuously during the event until 3h after the last participant has entered the event for 1h.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non-Exposure Event Exposure Event
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 141 260
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/m^3
Prior to Event
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
End of Event
NA [1] 
(NA to NA)
0.9776
(0.8105 to 1.179)
[1]
Below the limit of detection.
17.Secondary Outcome
Title Acetaldehyde [µg/m^3]
Hide Description To measure IAQ, in real-time, through the assessment of concentrations of nicotine and select HPHCs representative of ETS in the air of the study site. (ISO Norm 18144:2003)
Time Frame Measured at baseline for up to 3h prior to start of the event, then continuously during the event until 3h after the last participant has entered the event for 1h.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non-Exposure Event Exposure Event
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 141 260
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/m^3
Prior to Event
16.52
(15.50 to 17.60)
29.20
(26.02 to 32.78)
End of Event
110
(91.12 to 132.8)
187.4
(168.9 to 207.9)
18.Secondary Outcome
Title Acrolein [µg/m^3]
Hide Description To measure IAQ, in real-time, through the assessment of concentrations of nicotine and select HPHCs representative of ETS in the air of the study site. (ISO Norm 18144:2003)
Time Frame Measured at baseline for up to 3h prior to start of the event, then continuously during the event until 3h after the last participant has entered the event for 1h.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non-Exposure Event Exposure Event
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 141 260
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/m^3
Prior to Event
0.03291
(0.02976 to 0.03639)
0.07646
(0.06749 to 0.08662)
End of Event
0.07368
(0.05514 to 0.09845)
0.3288
(0.2841 to 0.3805)
19.Secondary Outcome
Title Crotonaldehyde [µg/m^3]
Hide Description To measure IAQ, in real-time, through the assessment of concentrations of nicotine and select HPHCs representative of ETS in the air of the study site. (ISO Norm 18144:2003)
Time Frame Measured at baseline for up to 3h prior to start of the event, then continuously during the event until 3h after the last participant has entered the event for 1h.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non-Exposure Event Exposure Event
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 141 260
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/m^3
Prior to Event
0.07621
(0.07024 to 0.08269)
0.09775
(0.09048 to 0.1056)
End of Event
0.1356
(0.1167 to 0.1577)
0.2523
(0.2335 to 0.2726)
20.Secondary Outcome
Title Formaldehyde [µg/m^3]
Hide Description To measure IAQ, in real-time, through the assessment of concentrations of nicotine and select HPHCs representative of ETS in the air of the study site. (ISO Norm 18144:2003)
Time Frame Measured at baseline for up to 3h prior to start of the event, then continuously during the event until 3h after the last participant has entered the event for 1h.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non-Exposure Event Exposure Event
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 141 260
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/m^3
Prior to Event
16.60
(15.42 to 17.87)
17.15
(16.20 to 18.16)
End of Event
17.49
(16.59 to 18.45)
22.74
(21.84 to 23.67)
21.Secondary Outcome
Title NNN [µg/m^3]
Hide Description

To measure IAQ, in real-time, through the assessment of concentrations of nicotine and select HPHCs representative of ETS in the air of the study site. (ISO Norm 18144:2003)

Note that the measurements were below the limit of detection.

Time Frame Measured at baseline for up to 3h prior to start of the event, then continuously during the event until 3h after the last participant has entered the event for 1h.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non-Exposure Event Exposure Event
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 141 260
Measure Type: Number
Unit of Measure: µg/m^3
Prior to Event NA [1]  NA [1] 
End of Event NA [1]  NA [1] 
[1]
Below the limit of detection.
22.Secondary Outcome
Title NNK [µg/m^3]
Hide Description

To measure IAQ, in real-time, through the assessment of concentrations of nicotine and select HPHCs representative of ETS in the air of the study site. (ISO Norm 18144:2003)

Note that the measurements of NNK [µg/m3] were below the limit of detection.

Time Frame Measured at baseline for up to 3h prior to start of the event, then continuously during the event until 3h after the last participant has entered the event for 1h.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non-Exposure Event Exposure Event
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 141 260
Measure Type: Number
Unit of Measure: µg/m^3
Prior to Event NA [1]  NA [1] 
End of Event NA [1]  NA [1] 
[1]
Below the limit of detection.
23.Secondary Outcome
Title PM1 Particles [µg/m^3]
Hide Description Real-time measurements of PM1 suspended particles in air. (ISO Norm 18144:2003)
Time Frame Measured at baseline for up to 3h prior to start of the event, then continuously during the event until 3h after the last participant has entered the event for 1h.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non-Exposure Event Exposure Event
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 141 260
Mean (95% Confidence Interval)
Unit of Measure: µg/m^3
Prior to Event
1.489
(1.367 to 1.611)
1.251
(1.150 to 1.353)
End of Event
11.508
(10.535 to 12.48)
9.991
(9.658 to 10.325)
24.Secondary Outcome
Title PM2.5 Particles [µg/m^3]
Hide Description Real-time measurements of PM2.5 suspended particles in air. (ISO Norm 18144:2003)
Time Frame Measured at baseline for up to 3h prior to start of the event, then continuously during the event until 3h after the last participant has entered the event for 1h.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non-Exposure Event Exposure Event
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 141 260
Mean (95% Confidence Interval)
Unit of Measure: µg/m^3
Prior to Event
1.585
(1.460 to 1.710)
1.340
(1.239 to 1.441)
End of Event
12.648
(11.568 to 13.720)
10.755
(10.405 to 11.100)
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.
Adverse Event Reporting 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.
 
Arm/Group Title Non-Smokers Cigarette Smokers IQOS Passive Users (Not Using IQOS) IQOS Active Users (Using IQOS)
Hide Arm/Group Description

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.).

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)

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.)

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.)
All-Cause Mortality
Non-Smokers Cigarette Smokers IQOS Passive Users (Not Using IQOS) IQOS Active Users (Using IQOS)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/190 (0.00%)   0/74 (0.00%)   0/77 (0.00%)   0/60 (0.00%) 
Hide Serious Adverse Events
Non-Smokers Cigarette Smokers IQOS Passive Users (Not Using IQOS) IQOS Active Users (Using IQOS)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/190 (0.00%)   0/74 (0.00%)   0/77 (0.00%)   0/60 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Non-Smokers Cigarette Smokers IQOS Passive Users (Not Using IQOS) IQOS Active Users (Using IQOS)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/190 (0.00%)   0/74 (0.00%)   0/77 (0.00%)   0/60 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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.

Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Christelle Haziza, Director Health Science and Biostatistics
Organization: Philip Morris Products S.A.
Phone: +41 58 242 11 11
EMail: ClinicalTrials.PMI@pmi.com
Layout table for additonal information
Responsible Party: Philip Morris Products S.A.
ClinicalTrials.gov Identifier: NCT03550989    
Other Study ID Numbers: P1-PES-01-JP
First Submitted: March 20, 2018
First Posted: June 11, 2018
Results First Submitted: May 23, 2019
Results First Posted: July 29, 2019
Last Update Posted: August 28, 2019