Real-Life Passive Exposure Assessment of IQOS

NCT03550989 | Completed Results

• 1 other identifier: P1-PES-01-JP
• Study Type: observational
• Target: 401
• Locations: 1 country
• Sites: 1

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.

Conditions

Environmental Exposure

Keywords

Environmental Aerosol Exposure; Environmental Tobacco Smoke; Indoor Air Quality

Outcome Measures

Primary Outcomes (6)

• NEQ: (Non-Exposure Event)

  To measure nicotine equivalents (NEQ, a biomarker of exposure to Nicotine): molar sum of free nicotine, nicotine-glucuronide, free cotinine, cotinine-glucuronide, free trans-3'-hydroxycotinine, trans-3'-hydroxycotinine-glucuronide in spot urine (expressed as concentration adjusted to creatinine).

  Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).

• NEQ: (Exposure Event)

  To measure nicotine equivalents (NEQ, a biomarker of exposure to Nicotine): molar sum of free nicotine, nicotine-glucuronide, free cotinine, cotinine-glucuronide, free trans-3'-hydroxycotinine, trans-3'-hydroxycotinine-glucuronide in spot urine (expressed as concentration adjusted to creatinine), during exposure events where some subjects used IQOS.

  Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).

• Total NNAL: (Non-Exposure Event)

  To measure Total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL, a BoExp to Tobacco Specific Nitrosamines) in spot urine (expressed as concentration adjusted to creatinine).

  Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).

• Total NNAL: (Exposure Event)

  To measure Total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL, a BoExp to Tobacco Specific Nitrosamines) in spot urine (expressed as concentration adjusted to creatinine), during exposure events where some subjects used IQOS.

  Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).

• Total NNN: (Non-Exposure Event)

  To measure Total N-nitrosonornicotine (Total NNN, a BoExp to Tobacco Specific Nitrosamines) in spot urine (expressed as concentration adjusted to creatinine).

  Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).

• Total NNN: (Exposure Event)

  To measure Total N-nitrosonornicotine (Total NNN, a BoExp to Tobacco Specific Nitrosamines) in spot urine (expressed as concentration adjusted to creatinine) during exposure events where some subjects used IQOS.

  Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).

Secondary Outcomes (18)

• HPMA (Non-Exposure Events)

  Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).

• HPMA (Exposure Events)

  Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).

• 3-HPMA (Non-Exposure Events)

  Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).

• 3-HPMA (Exposure Events)

  Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).

• S-PMA (Non-Exposure Events)

  Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).

Study Arms (4)

Non-Smokers

Each participant can participate in one Non-Exposure Event and one Exposure Event only. * Abstinent for at least 12 months from the use of any nicotine and/or tobacco-containing product based on self-reporting. * Must not be exposed to tobacco or nicotine-containing products use in any other substantial way (family, partner, workplace, etc.).

Other: Non-Exposure Event; Other: Exposure Event

Cigarette Smokers

Each participant can participate in one Non-Exposure Event and one Exposure Event only. * Used at least 100 cigarettes * Smokes cigarettes daily \> 1/day * Uses IQOS less than daily * Uses less than 30 HeatSticks/month * Cigarette is \> 95% of tobacco/nicotine product (all product use)

Other: Non-Exposure Event; Other: Exposure Event

IQOS Passive Users (not using IQOS)

Each participant can participate in one Non-Exposure Event and one Exposure Event only. * Used at least 100 HeatSticks * Uses IQOS daily \> 1/day * Smokes a cigarette less than daily * Smokes less than 30 cigarettes/month * IQOS is \> 95% of tobacco/nicotine product (all product use) - excluding other products (e-cig/Ploom/etc.)

Other: Non-Exposure Event; Other: Exposure Event

IQOS Active Users (using IQOS)

Each participant can participate in one Exposure Event only. * Used at least 100 HeatSticks * Uses IQOS daily \> 1/day * Smokes a cigarette less than daily * Smokes less than 30 cigarettes/month * IQOS is \> 95% of tobacco/nicotine product (all product use) - excluding other products (e-cig/Ploom/etc.)

Other: Exposure Event

Interventions

Non-Exposure Event OTHER

Non-Exposure event of 4h duration for the individual participants, where no use of any tobacco or nicotine-containing product is allowed, designed to establish background measurements in the absence of exposure to IQOS.

Cigarette Smokers; IQOS Passive Users (not using IQOS); Non-Smokers

Exposure Event OTHER

Exposure Event designed to measure urinary BoExp to selected HPHCs representative of ETS in all participant groups, with up to 5h of exposure to IQOS tobacco environmental aerosol for non-smokers, cigarette smokers (not using any tobacco or nicotine-containing product, including cigarettes), and IQOS passive users (not using IQOS). Additionally, this event includes up to 8h of exposure for IQOS active users (using IQOS).

Cigarette Smokers; IQOS Active Users (using IQOS); IQOS Passive Users (not using IQOS); Non-Smokers

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female or male Japanese IQOS Users, Cigarette smokers, or Non-Smokers.

You may qualify if:

• 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

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Philip Morris Products S.A.: lead

Study Sites (1)

Angepatio Restaurant

Shibuya-ku, Tokyo, 150-0036, Japan

Location

Results Point of Contact

• Title: Christelle Haziza, Director Health Science and Biostatistics
• Organization: Philip Morris Products S.A.

ClinicalTrials.PMI@pmi.com

+41 58 242 11 11

Study Officials

• Patrick Picavet, MD

  Philip Morris Products S.A.

  STUDY CHAIR

• Takao Ohki, MD, PhD

  Jikei University School of Medicine, Tokyo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2018
• First Posted: June 11, 2018
• Study Start: December 5, 2017
• Primary Completion: April 30, 2018
• Study Completion: May 16, 2018
• Last Updated: August 28, 2019
• Results First Posted: July 29, 2019

Record last verified: 2019-08

Locations

JP (1)