N/A
N=401
Real-Life Passive Exposure Assessment of IQOS
Environmental Exposure
Bottom Line
View on ClinicalTrials.gov: NCT03550989 ↗Enrolled (actual)
401
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: NEQ: (Non-Exposure Event) — 0.03845; 4.159; 5.695; 0.06876 mg/g
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Non-Exposure Event (Other); Exposure Event (Other)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Philip Morris Products S.A.
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY NEQ: (Non-Exposure Event) |
0.03845; 4.159; 5.695; 0.06876; 5.175; 6.821 | — |
| PRIMARY NEQ: (Exposure Event) |
0.04078; 3.051; 5.277; 4.683; 0.06205; 2.889 | — |
| PRIMARY Total NNAL: (Non-Exposure Event) |
NA; 69.65; 20.55; NA; 81.64; 27.41 | — |
| PRIMARY Total NNAL: (Exposure Event) |
NA; 48.57; 19.68; 21.50; NA; 58.74 | — |
| PRIMARY Total NNN: (Non-Exposure Event) |
NA; 3.945; 1.493; NA; 4.008; 3.093 | — |
| PRIMARY Total NNN: (Exposure Event) |
NA; 2.694; 1.753; 0.9088; NA; 3.992 | — |
| SECONDARY HPMA (Non-Exposure Events) |
103.2; 318.6; 133.2; 232.6; 307.7; 211.9 | — |
| SECONDARY HPMA (Exposure Events) |
82.91; 233.4; 92.85; 103.0; 170.9; 224.1 | — |
| SECONDARY 3-HPMA (Non-Exposure Events) |
242.1; 935.7; 454.9; 1108; 1334; 1240 | — |
| SECONDARY 3-HPMA (Exposure Events) |
246.6; 840.6; 404.4; 381.1; 1982; 2051 | — |
| SECONDARY S-PMA (Non-Exposure Events) |
113.2; 1441; 192.6; 132.0; 1023; 201.3 | — |
| SECONDARY S-PMA (Exposure Events) |
123.5; 735.1; 151.9; 195.3; 136.9; 612.5 | — |
| SECONDARY HEMA (Non-Exposure Events) |
635.1; 1671; 629.1; 1299; 2595; 1520 | — |
| SECONDARY HEMA (Exposure Events) |
651.3; 1143; 675.0; 705.0; 1486; 1967 | — |
| SECONDARY 3-Ethenylpyridine (3-EP) [µg/m^3] |
NA; NA; NA; NA | — |
| SECONDARY Nicotine [µg/m^3] |
NA; NA; NA; 0.9776 | — |
| SECONDARY Acetaldehyde [µg/m^3] |
16.52; 29.20; 110; 187.4 | — |
| SECONDARY Acrolein [µg/m^3] |
0.03291; 0.07646; 0.07368; 0.3288 | — |
| SECONDARY Crotonaldehyde [µg/m^3] |
0.07621; 0.09775; 0.1356; 0.2523 | — |
| SECONDARY Formaldehyde [µg/m^3] |
16.60; 17.15; 17.49; 22.74 | — |
| SECONDARY NNN [µg/m^3] |
NA; NA; NA; NA | — |
| SECONDARY NNK [µg/m^3] |
NA; NA; NA; NA | — |
| SECONDARY PM1 Particles [µg/m^3] |
1.489; 1.251; 11.508; 9.991 | — |
| SECONDARY PM2.5 Particles [µg/m^3] |
1.585; 1.340; 12.648; 10.755 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT03550989). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.