Second Hand Tobacco Smoke
Conditions
Keywords
E-Cigarettes, Conventional Cigarettes, JUUL, VUSE
Brief summary
An open-label, single center, three-arm observational study to examine emissions from e-cigarettes versus conventional cigarettes under three environmental settings of typical residential, office and hospitality facilities.
Detailed description
Specific constituents will be measured in exhaled breath samples (EBS) from adult e-vapor product users and smokers when they are using e-vapor products or smoking conventional cigarettes. These constituents and particle counts (PC), will be measured in the room air samples (RAS) collected in the environmental exposure chamber (EEC) where adult e-cigarette users and smokers are using electronic cigarettes or smoking conventional cigarettes. All subjects will undergo a Screening Visit to assess if they meet study eligibility criteria. If all eligibility criteria are met and the subject signs informed consent, the subject will be assigned to one of three groups: Group I (JUUL), Group II (VUSE Solo), or Group III (Conventional Cigarettes). All three Groups will be sequentially observed in environmental settings 1 (residential), 2 (office), and 3 (hospitality). The observation period allocated for each environmental setting will be 2-days and 2-overnights for Groups I and II, and 1-day and 1-overnight for Group III. Each observation period will be referred to as a Clinic Visit. Subjects will move on to subsequent Environment Settings (Clinic Visits 2 or 3) after completion of the previous Clinic Visit (1 or 2). Subjects must return to the clinic for Clinic Visit 1 within 60 days of the Screening Visit. Clinic Visit 2 must occur 7 ± 2 days after the Clinic Visit 1, and Clinic Visit 3 must occur 7 ± 2 days after Clinic Visit 2.
Interventions
OTHERJUUL
JUUL Virginia Tobacco
OTHERVUSE Solo
VUSE SOLO Original
Subject preferred conventional cigarette
Sponsors
Inflamax Research Incorporated
Juul Labs, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Subjects must satisfy the following criteria before being enrolled into the study. Subjects must: 1. Be informed of the nature of the study and agree to and are able to read, review, and sign the informed consent document (in English) prior to the first study procedure. The Investigator must be satisfied that the volunteer has the ability to read and communicate in English in order to participate in the study. 2. Subjects screened as a part of an IRB-approved General Screening Protocol at the CRO site may be included in this study without additional Screening procedures provided all the required Screening procedures have been performed within 60 days prior to Clinic Visit 1. 3. Be a healthy male or female volunteer aged 21 - 65 years at the time of Screening Visit. 4. Have a positive urine cotinine result at Screening (Screening Visit) of \>200 ng/ml. 5. Be judged by the Investigator to be in good general health as documented by the medical history, physical examination (including but may not be limited to an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems), vital sign assessments, 12-lead electrocardiogram (ECG), clinical laboratory assessments, and by general observations. Any abnormalities or deviations outside the normal ranges for any clinical testing (laboratory tests, ECG, vital signs) can be repeated at the discretion of the Investigator and judged to be not clinically significant for study participation. 6. Agree to abide by the study restrictions and return for the required assessments. 7. Have a self-reported daily conventional cigarette consumption rate of a minimum of 10 cigarettes per day for a minimum of 3 months prior to Screening Visit.
Exclusion criteria
Subjects who meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exhaled Breath Sample (EBS) - Nicotine | Clinic Visit (JUUL/VUSE: 2 days and 2 overnights; conventional cigarette: 1 day and 1 overnight) | Absolute change from baseline in nicotine levels in the EBS of subjects who use JUUL, VUSE Solo, or conventional cigarettes. |
| Exhaled Breath Sample (EBS) - Propylene glycol | Clinic Visit (JUUL/VUSE: 2 days and 2 overnights; conventional cigarette: 1 day and 1 overnight) | Absolute change from baseline in propylene glycol levels in the EBS of subjects who use JUUL, VUSE Solo, or conventional cigarettes. |
| Exhaled Breath Sample (EBS) - Vegetable Glycerin | Clinic Visit (JUUL/VUSE: 2 days and 2 overnights; conventional cigarette: 1 day and 1 overnight) | Absolute change from baseline in vegetable glycerin levels in the EBS of subjects who use JUUL, VUSE Solo, or conventional cigarettes. |
| Exhaled Breath Sample (EBS) - Carbonyls | Clinic Visit (JUUL/VUSE: 2 days and 2 overnights; conventional cigarette: 1 day and 1 overnight) | Absolute change from baseline in carbonyl levels in the EBS of subjects who use JUUL, VUSE Solo, or conventional cigarettes. Carbonyl compounds include: formaldehyde, acetaldehyde, and acrolein. |
| Room Air Sample (RAS) - Nicotine | Clinic Visit (JUUL/VUSE: 2 days and 2 overnights; conventional cigarette: 1 day and 1 overnight) | Absolute change from baseline in nicotine levels in the room air when subjects use JUUL or VUSE Solo over 4-hour prescribed conditions and JUUL, VUSE Solo, or conventional cigarettes over 4-hour ad libitum conditions. |
| Room Air Sample (RAS) - Propylene glycol | Clinic Visit (JUUL/VUSE: 2 days and 2 overnights; conventional cigarette: 1 day and 1 overnight) | Absolute change from baseline in propylene glycol levels in the room air when subjects use JUUL or VUSE Solo over 4-hour prescribed conditions and JUUL, VUSE Solo, or conventional cigarettes over 4-hour ad libitum conditions. |
| Room Air Sample (RAS) - Vegetable Glycerin | Clinic Visit (JUUL/VUSE: 2 days and 2 overnights; conventional cigarette: 1 day and 1 overnight) | Absolute change from baseline in vegetable glycerin levels in the room air when subjects use JUUL or VUSE Solo over 4-hour prescribed conditions and JUUL, VUSE Solo, or conventional cigarettes over 4-hour ad libitum conditions. |
| Room Air Sample (RAS) - Carbonyls | Clinic Visit (JUUL/VUSE: 2 days and 2 overnights; conventional cigarette: 1 day and 1 overnight) | Absolute change from baseline in carbonyl levels in the room air when subjects use JUUL or VUSE Solo over 4-hour prescribed conditions and JUUL, VUSE Solo, or conventional cigarettes over 4-hour ad libitum conditions. Carbonyl compounds include: formaldehyde, crotonaldehyde, o-tolualdehyde, acetaldehyde, butyraldehyde (butanal), m&p-tolualdehyde, acetone, benzaldehyde, propionaldehyde, isovaleraldehyde, hexanaldehyde (aka hexaldehyde), valeraldehyde, 2, 5-dimethylbenzaldehyde, methyl ethyl ketone (MEK), acrolein. |
| Room Air Sample (RAS) - Volatile organic compounds | Clinic Visit (JUUL/VUSE: 2 days and 2 overnights; conventional cigarette: 1 day and 1 overnight) | Absolute change from baseline in volatile organic compound levels in the room air when subjects use JUUL or VUSE Solo over 4-hour prescribed conditions and JUUL, VUSE Solo, or conventional cigarettes over 4-hour ad libitum conditions. Volatile organic compounds include: 1,3-butadiene, Benzene, isoprene, toluene, furan, ethylene oxide, vinyl chloride, propylene oxide, nitromethane, 2-nitropropane, vinyl acetate, ethylbenzene |
| Room Air Samples (RAS) - Metals | Clinic Visit (JUUL/VUSE: 2 days and 2 overnights; conventional cigarette: 1 day and 1 overnight) | Absolute change from baseline in metal levels in the room air when subjects use JUUL or VUSE Solo over 4-hour prescribed conditions and JUUL, VUSE Solo, or conventional cigarettes over 4-hour ad libitum conditions. Metals include: arsenic, cadmium, chromium, nickel. |
| Room Air Samples (RAS) - PM2.5 Particles | Clinic Visit (JUUL/VUSE: 2 days and 2 overnights; conventional cigarette: 1 day and 1 overnight) | Absolute change from baseline levels of PM2.5 particles in room air when subjects use JUUL or VUSE Solo over 4-hour prescribed conditions and JUUL, VUSE Solo, or conventional cigarettes over 4-hour ad libitum conditions. |
| Room Air Samples (RAS) - PM10 Particles | Clinic Visit (JUUL/VUSE: 2 days and 2 overnights; conventional cigarette: 1 day and 1 overnight) | Absolute change from baseline levels of PM10 particles in room air when subjects use JUUL or VUSE Solo over 4-hour prescribed conditions and JUUL, VUSE Solo, or conventional cigarettes over 4-hour ad libitum conditions. |
Countries
Canada
Outcome results
None listed