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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.

Tracking Information
First Submitted Date March 20, 2018
First Posted Date June 11, 2018
Results First Submitted Date May 23, 2019
Results First Posted Date July 29, 2019
Last Update Posted Date August 28, 2019
Actual Study Start Date December 5, 2017
Actual Primary Completion Date April 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 23, 2019)
  • NEQ: (Non-Exposure Event) [ Time Frame: Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure). ]
    To measure nicotine equivalents (NEQ, a biomarker of exposure to Nicotine): molar sum of free nicotine, nicotine-glucuronide, free cotinine, cotinine-glucuronide, free trans-3'-hydroxycotinine, trans-3'-hydroxycotinine-glucuronide in spot urine (expressed as concentration adjusted to creatinine).
  • NEQ: (Exposure Event) [ Time Frame: Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure). ]
    To measure nicotine equivalents (NEQ, a biomarker of exposure to Nicotine): molar sum of free nicotine, nicotine-glucuronide, free cotinine, cotinine-glucuronide, free trans-3'-hydroxycotinine, trans-3'-hydroxycotinine-glucuronide in spot urine (expressed as concentration adjusted to creatinine), during exposure events where some subjects used IQOS.
  • Total NNAL: (Non-Exposure Event) [ Time Frame: Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure). ]
    To measure Total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL, a BoExp to Tobacco Specific Nitrosamines) in spot urine (expressed as concentration adjusted to creatinine).
  • Total NNAL: (Exposure Event) [ Time Frame: Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure). ]
    To measure Total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL, a BoExp to Tobacco Specific Nitrosamines) in spot urine (expressed as concentration adjusted to creatinine), during exposure events where some subjects used IQOS.
  • Total NNN: (Non-Exposure Event) [ Time Frame: Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure). ]
    To measure Total N-nitrosonornicotine (Total NNN, a BoExp to Tobacco Specific Nitrosamines) in spot urine (expressed as concentration adjusted to creatinine).
  • Total NNN: (Exposure Event) [ Time Frame: Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure). ]
    To measure Total N-nitrosonornicotine (Total NNN, a BoExp to Tobacco Specific Nitrosamines) in spot urine (expressed as concentration adjusted to creatinine) during exposure events where some subjects used IQOS.
Original Primary Outcome Measures
 (submitted: May 25, 2018)
  • Biomarker of exposure (BoExp) to Nicotine, representative of environmental tobacco smoke (ETS) after passive exposure to 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). ]
    To measure nicotine equivalents (NEQ): 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).
  • BoExp to Tobacco Specific Nitrosamines (TSNAs), representative of environmental tobacco smoke (ETS) after passive exposure to 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). ]
    To measure Total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL) and Total N-nitrosonornicotine (Total NNN) in spot urine (expressed as concentration adjusted to creatinine).
Change History
Current Secondary Outcome Measures
 (submitted: August 19, 2019)
  • HPMA (Non-Exposure Events) [ Time Frame: Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure). ]
    To measure 3-hydroxy-1-methylpropylmercapturic acid (HMPMA, a BoExp to Crotonaldehyde ) in spot urine (concentration adjusted for creatinine).
  • HPMA (Exposure Events) [ Time Frame: Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure). ]
    To measure 3-hydroxy-1-methylpropylmercapturic acid (HMPMA, a BoExp to Crotonaldehyde ) in spot urine (concentration adjusted for creatinine), during exposure events where some subjects used IQOS.
  • 3-HPMA (Non-Exposure Events) [ Time Frame: Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure). ]
    To measure 3 hydroxypropylmercapturic acid (3-HPMA, a BoExp to Acrolein) in spot urine (concentration adjusted for creatinine).
  • 3-HPMA (Exposure Events) [ Time Frame: Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure). ]
    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.
  • S-PMA (Non-Exposure Events) [ Time Frame: Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure). ]
    To measure S-phenylmercapturic acid (S-PMA, a BoExp to Benzene) in spot urine (concentration adjusted for creatinine).
  • S-PMA (Exposure Events) [ Time Frame: Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure). ]
    To measure S-phenylmercapturic acid (S-PMA, a BoExp to Benzene ) in spot urine (concentration adjusted for creatinine), during exposure events where some subjects used IQOS.
  • HEMA (Non-Exposure Events) [ Time Frame: Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure). ]
    To measure 2-hydroxyethyl mercapturic acid (HEMA, a BoExp to Ethylene Oxide) in spot urine (concentration adjusted for creatinine).
  • HEMA (Exposure Events) [ Time Frame: Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure). ]
    To measure 2-hydroxyethyl mercapturic acid (HEMA, a BoExp to Ethylene Oxide) in spot urine (concentration adjusted for creatinine), during exposure events where some subjects used IQOS.
  • 3-Ethenylpyridine (3-EP) [µg/m^3] [ 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. ]
    To measure IAQ, in real-time, through the assessment of concentrations of nicotine and select HPHCs representative of ETS in the air of the study site. (ISO Norm 18144:2003) Note that the measurements of 3-EP [µg/m^3] were below the limit of detection.
  • Nicotine [µg/m^3] [ 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. ]
    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)
  • Acetaldehyde [µg/m^3] [ Time Frame: Measured at baseline for up to 3h prior to start of the event, then continuously during the event until 3h after the last participant has entered the event for 1h. ]
    To measure IAQ, in real-time, through the assessment of concentrations of nicotine and select HPHCs representative of ETS in the air of the study site. (ISO Norm 18144:2003)
  • Acrolein [µg/m^3] [ 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. ]
    To measure IAQ, in real-time, through the assessment of concentrations of nicotine and select HPHCs representative of ETS in the air of the study site. (ISO Norm 18144:2003)
  • Crotonaldehyde [µg/m^3] [ 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. ]
    To measure IAQ, in real-time, through the assessment of concentrations of nicotine and select HPHCs representative of ETS in the air of the study site. (ISO Norm 18144:2003)
  • Formaldehyde [µg/m^3] [ 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. ]
    To measure IAQ, in real-time, through the assessment of concentrations of nicotine and select HPHCs representative of ETS in the air of the study site. (ISO Norm 18144:2003)
  • NNN [µg/m^3] [ 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. ]
    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.
  • NNK [µg/m^3] [ Time Frame: Measured at baseline for up to 3h prior to start of the event, then continuously during the event until 3h after the last participant has entered the event for 1h. ]
    To measure IAQ, in real-time, through the assessment of concentrations of nicotine and select HPHCs representative of ETS in the air of the study site. (ISO Norm 18144:2003) Note that the measurements of NNK [µg/m3] were below the limit of detection.
  • PM1 Particles [µg/m^3] [ 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. ]
    Real-time measurements of PM1 suspended particles in air. (ISO Norm 18144:2003)
  • PM2.5 Particles [µg/m^3] [ Time Frame: Measured at baseline for up to 3h prior to start of the event, then continuously during the event until 3h after the last participant has entered the event for 1h. ]
    Real-time measurements of PM2.5 suspended particles in air. (ISO Norm 18144:2003)
Original Secondary Outcome Measures
 (submitted: May 25, 2018)
  • BoExp to Nicotine (representative of ETS during both the Non-Exposure Events and Exposure Events in all study participants) [ Time Frame: Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure). ]
    To measure NEQ: 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).
  • BoExp to TSNAs (representative of ETS during both the Non-Exposure Events and Exposure Events in all study participants) [ Time Frame: Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure). ]
    To measure Total NNAL and Total NNN in spot urine (expressed as concentration adjusted to creatinine).
  • BoExp to Crotonaldehyde (Carbonyl, representative of ETS during both the Non-Exposure Events and Exposure Events in all study participants) [ Time Frame: Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure). ]
    To measure 3-hydroxy-1-methylpropylmercapturic acid (HMPMA) in spot urine (concentration adjusted for creatinine).
  • BoExp to Acrolein (Carbonyl, representative of ETS during both the Non-Exposure Events and Exposure Events in all study participants) [ Time Frame: Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure). ]
    To measure 3 hydroxypropylmercapturic acid (3 HPMA) in spot urine (concentration adjusted for creatinine).
  • BoExp to Benzene (Volatile Organic Compound, representative of ETS during both the Non-Exposure Events and Exposure Events in all study participants) [ Time Frame: Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure). ]
    To measure S-phenylmercapturic acid (S-PMA) in spot urine (concentration adjusted for creatinine).
  • BoExp to Ethylene Oxide (representative of ETS during both the Non-Exposure Events and Exposure Events in all study participants). [ Time Frame: Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure). ]
    To measure 2-hydroxyethyl mercapturic acid (HEMA) in spot urine (concentration adjusted for creatinine).
  • 3-Ethenylpyridine (3-EP) [µg/m3] [ 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. ]
    To measure IAQ, in real-time, through the assessment of concentrations of select HPHCs representative of ETS in the air of the study site. (ISO Norm 18144:2003)
  • Nicotine [µg/m3] [ 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. ]
    To measure IAQ, in real-time, through the assessment of concentrations of select HPHCs representative of ETS in the air of the study site. (ISO Norm 18144:2003)
  • Acetaldehyde [µg/m3] [ 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. ]
    To measure IAQ, in real-time, through the assessment of concentrations of select HPHCs representative of ETS in the air of the study site. (ISO Norm 18144:2003)
  • Acrolein [µg/m3] [ 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. ]
    To measure IAQ, in real-time, through the assessment of concentrations of select HPHCs representative of ETS in the air of the study site. (ISO Norm 18144:2003)
  • Crotonaldehyde [µg/m3] [ 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. ]
    To measure IAQ, in real-time, through the assessment of concentrations of select HPHCs representative of ETS in the air of the study site. (ISO Norm 18144:2003)
  • Formaldehyde [µg/m3] [ 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. ]
    To measure IAQ, in real-time, through the assessment of concentrations of select HPHCs representative of ETS in the air of the study site. (ISO Norm 18144:2003)
  • NNN [µg/m3] [ 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. ]
    To measure IAQ, in real-time, through the assessment of concentrations of select HPHCs representative of ETS in the air of the study site. (ISO Norm 18144:2003)
  • NNK [µg/m3] [ 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. ]
    To measure IAQ, in real-time, through the assessment of concentrations of select HPHCs representative of ETS in the air of the study site. (ISO Norm 18144:2003)
  • PM1-PM10 particles [ 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. ]
    Real-time measurements of PM1-PM10 suspended particles in air. (ISO Norm 18144:2003)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Real-Life Passive Exposure Assessment of IQOS
Official Title Assessment of Passive Environmental Aerosol Exposure Through IQOS (Tobacco Heating System [THS] With Marlboro Heatsticks) in a Restaurant Setting Where IQOS Use, But Not Cigarette Smoking, is Allowed.
Brief Summary This study is a non-interventional observational study designed to assess the impact of passive exposure to IQOS environmental tobacco aerosol in Non-Smokers in a real-life restaurant setting.
Detailed Description

The purpose of the study is to show that Non-Smokers, exposed to environmental tobacco aerosol from IQOS in a restaurant setting, do not have higher urinary levels of Biomarkers of Exposure (BoExp) to selected Harmful and Potentially Harmful Constituents (HPHCs), representative of Environmental Tobacco Smoke (ETS), compared to the urinary levels of BoExp measured in Non-Smokers before IQOS environmental tobacco aerosol exposure.

Furthermore, the impact of passive exposure to IQOS environmental tobacco aerosol on IQOS Users and Cigarette Smokers, not using any tobacco or nicotine-containing products, will be investigated. This will enable the assessment of individuals with varying levels of exposure to HPHCs and determine whether there is any measurable additional exposure related to the environmental tobacco aerosol from IQOS.

The study will also evaluate Indoor Air Quality (IAQ) through the assessment of concentrations of nicotine and selected HPHCs representative of tobacco-specific and IAQ markers in the air during exposure and non-exposure periods in a real-life restaurant setting.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Female or male Japanese IQOS Users, Cigarette smokers, or Non-Smokers.
Condition Environmental Exposure
Intervention
  • Other: 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.
  • Other: Exposure Event
    Exposure Event designed to measure urinary BoExp to selected HPHCs representative of ETS in all participant groups, with up to 5h of exposure to IQOS tobacco environmental aerosol for non-smokers, cigarette smokers (not using any tobacco or nicotine-containing product, including cigarettes), and IQOS passive users (not using IQOS). Additionally, this event includes up to 8h of exposure for IQOS active users (using IQOS).
Study Groups/Cohorts
  • 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.).
    Interventions:
    • Other: Non-Exposure Event
    • Other: Exposure Event
  • Cigarette Smokers

    Each participant can participate in one Non-Exposure Event and one Exposure Event only.

    • Used at least 100 cigarettes
    • Smokes cigarettes daily > 1/day
    • Uses IQOS less than daily
    • Uses less than 30 HeatSticks/month
    • Cigarette is > 95% of tobacco/nicotine product (all product use)
    Interventions:
    • Other: Non-Exposure Event
    • Other: Exposure Event
  • IQOS Passive Users (not using IQOS)

    Each participant can participate in one Non-Exposure Event and one Exposure Event only.

    • Used at least 100 HeatSticks
    • Uses IQOS daily > 1/day
    • Smokes a cigarette less than daily
    • Smokes less than 30 cigarettes/month
    • IQOS is > 95% of tobacco/nicotine product (all product use) - excluding other products (e-cig/Ploom/etc.)
    Interventions:
    • Other: Non-Exposure Event
    • Other: Exposure Event
  • IQOS Active Users (using IQOS)

    Each participant can participate in one Exposure Event only.

    • Used at least 100 HeatSticks
    • Uses IQOS daily > 1/day
    • Smokes a cigarette less than daily
    • Smokes less than 30 cigarettes/month
    • IQOS is > 95% of tobacco/nicotine product (all product use) - excluding other products (e-cig/Ploom/etc.)
    Intervention: Other: Exposure Event
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 23, 2019)
401
Original Actual Enrollment
 (submitted: May 25, 2018)
338
Actual Study Completion Date May 16, 2018
Actual Primary Completion Date April 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Participant is able to understand the information provided in the Subject Information Sheet (SIS) and Informed Consent Form (ICF) (confirmed by signing the ICF) and has signed the ICF.
  • Adults legally authorized to buy tobacco products in Japan (20 years of age).
  • Participant is Japanese as self-reported.
  • Willing to participate in the study, comply with study procedures and has access to the Internet.
  • Participant is an active IQOS User, Cigarette smoker or Non-Smoker as self-reported

Exclusion Criteria:

  • Participant with a medical history of severe cardiovascular or respiratory diseases (e.g., stroke, acute cardiovascular event, pulmonary thrombosis) in the last 12 months as self-reported.
  • Participant with currently active cancer or history of cancer within the last 5 years as self-reported.
  • Female participant who is pregnant or breast-feeding as self-reported.
  • Participant is a current or former employee of the tobacco industry or their first-degree relatives (parent and child).
  • Participant is an employee of Philip Morris International (PMI), an employee of the Contract Research Organization (CRO) engaged for this study, an employee of the CRO's vendors, an employee of the restaurant/event location, or their first-degree relatives (parent or child).

Exclusion criteria specific to participants who are Non-Smokers:

  • Participant lives in a household with users of tobacco or nicotine-containing products, or is exposed to the use of tobacco or nicotine-containing products at the workplace.
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT03550989
Other Study ID Numbers P1-PES-01-JP
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Philip Morris Products S.A.
Study Sponsor Philip Morris Products S.A.
Collaborators Not Provided
Investigators
Study Chair: Patrick Picavet, MD Philip Morris Products S.A.
Principal Investigator: Takao Ohki, MD, PhD Jikei University School of Medicine, Tokyo
PRS Account Philip Morris Products S.A.
Verification Date August 2019