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| Name | Class |
|---|---|
| Inflamax Research Incorporated | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JUUL electronic cigarette | Experimental | JUUL electronic cigarette. Virginia Tobacco 5% tobacco-derived nicotine. |
|
| VUSE Solo electronic cigarette | Active Comparator | Reynolds American International VUSE Solo electronic cigarette. Original flavor 4.8% tobacco-derived nicotine. |
|
| Conventional cigarette | Active Comparator | Canadian purchased, store bought (not hand-rolled) conventional full-flavored cigarettes of subjects' preference. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JUUL | Other | JUUL Virginia Tobacco |
| |
| VUSE Solo |
| Measure | Description | Time Frame |
|---|---|---|
| Exhaled Breath Sample (EBS) - Nicotine | Absolute change from baseline in nicotine levels in the EBS of subjects who use JUUL, VUSE Solo, or conventional cigarettes. | Clinic Visit (JUUL/VUSE: 2 days and 2 overnights; conventional cigarette: 1 day and 1 overnight) |
| Exhaled Breath Sample (EBS) - Propylene glycol | Absolute change from baseline in propylene glycol levels in the EBS of subjects who use JUUL, VUSE Solo, or conventional cigarettes. | Clinic Visit (JUUL/VUSE: 2 days and 2 overnights; conventional cigarette: 1 day and 1 overnight) |
| Exhaled Breath Sample (EBS) - Vegetable Glycerin | Absolute change from baseline in vegetable glycerin levels in the EBS of subjects who use JUUL, VUSE Solo, or conventional cigarettes. | Clinic Visit (JUUL/VUSE: 2 days and 2 overnights; conventional cigarette: 1 day and 1 overnight) |
| Exhaled Breath Sample (EBS) - Carbonyls | 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. | Clinic Visit (JUUL/VUSE: 2 days and 2 overnights; conventional cigarette: 1 day and 1 overnight) |
| Room Air Sample (RAS) - Nicotine | 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. | Clinic Visit (JUUL/VUSE: 2 days and 2 overnights; conventional cigarette: 1 day and 1 overnight) |
| Room Air Sample (RAS) - Propylene glycol |
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Inclusion Criteria:
Subjects must satisfy the following criteria before being enrolled into the study. Subjects must:
Exclusion Criteria:
Subjects who meet any of the following exclusion criteria will not be enrolled in the study.
Subjects must not:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Couroux, MD | Inflamax Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inflamax Research Limited | Mississauga | Ontario | L4W 1A4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24365545 | Background | Bam TS, Bellew W, Berezhnova I, Jackson-Morris A, Jones A, Latif E, Molinari MA, Quan G, Singh RJ, Wisotzky M; Tobacco Control Department International Union Against Tuberculosis and Lung Disease. Position statement on electronic cigarettes or electronic nicotine delivery systems. Int J Tuberc Lung Dis. 2014 Jan;18(1):5-7. doi: 10.5588/ijtld.13.0815. No abstract available. | |
| 24373737 |
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| ID | Term |
|---|---|
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D001519 | Behavior |
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| Other |
VUSE SOLO Original |
|
| Conventional Cigarette | Other | Subject preferred conventional cigarette |
|
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. |
| Clinic Visit (JUUL/VUSE: 2 days and 2 overnights; conventional cigarette: 1 day and 1 overnight) |
| Room Air Sample (RAS) - Vegetable Glycerin | 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. | Clinic Visit (JUUL/VUSE: 2 days and 2 overnights; conventional cigarette: 1 day and 1 overnight) |
| Room Air Sample (RAS) - Carbonyls | 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. | Clinic Visit (JUUL/VUSE: 2 days and 2 overnights; conventional cigarette: 1 day and 1 overnight) |
| Room Air Sample (RAS) - Volatile organic compounds | 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 | Clinic Visit (JUUL/VUSE: 2 days and 2 overnights; conventional cigarette: 1 day and 1 overnight) |
| Room Air Samples (RAS) - Metals | 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. | Clinic Visit (JUUL/VUSE: 2 days and 2 overnights; conventional cigarette: 1 day and 1 overnight) |
| Room Air Samples (RAS) - PM2.5 Particles | 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. | Clinic Visit (JUUL/VUSE: 2 days and 2 overnights; conventional cigarette: 1 day and 1 overnight) |
| Room Air Samples (RAS) - PM10 Particles | 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. | Clinic Visit (JUUL/VUSE: 2 days and 2 overnights; conventional cigarette: 1 day and 1 overnight) |
| Background |
| Schober W, Szendrei K, Matzen W, Osiander-Fuchs H, Heitmann D, Schettgen T, Jorres RA, Fromme H. Use of electronic cigarettes (e-cigarettes) impairs indoor air quality and increases FeNO levels of e-cigarette consumers. Int J Hyg Environ Health. 2014 Jul;217(6):628-37. doi: 10.1016/j.ijheh.2013.11.003. Epub 2013 Dec 6. |
| 22672560 | Background | Schripp T, Markewitz D, Uhde E, Salthammer T. Does e-cigarette consumption cause passive vaping? Indoor Air. 2013 Feb;23(1):25-31. doi: 10.1111/j.1600-0668.2012.00792.x. Epub 2012 Jul 2. |
| 24336346 | Background | Czogala J, Goniewicz ML, Fidelus B, Zielinska-Danch W, Travers MJ, Sobczak A. Secondhand exposure to vapors from electronic cigarettes. Nicotine Tob Res. 2014 Jun;16(6):655-62. doi: 10.1093/ntr/ntt203. Epub 2013 Dec 11. |
| 24732165 | Background | Chang H. Research gaps related to the environmental impacts of electronic cigarettes. Tob Control. 2014 May;23 Suppl 2(Suppl 2):ii54-8. doi: 10.1136/tobaccocontrol-2013-051480. |
| 28846634 | Background | Liu J, Liang Q, Oldham MJ, Rostami AA, Wagner KA, Gillman IG, Patel P, Savioz R, Sarkar M. Determination of Selected Chemical Levels in Room Air and on Surfaces after the Use of Cartridge- and Tank-Based E-Vapor Products or Conventional Cigarettes. Int J Environ Res Public Health. 2017 Aug 28;14(9):969. doi: 10.3390/ijerph14090969. |
| 27734060 | Background | Hess IM, Lachireddy K, Capon A. A systematic review of the health risks from passive exposure to electronic cigarette vapour. Public Health Res Pract. 2016 Apr 15;26(2):2621617. doi: 10.17061/phrp2621617. |
| Background | ANSI/ASHRAE Standard 62.1-2016. Ventilation for Acceptable Indoor Air Quality. American Society of Heating, Refrigerating and Air-Conditioning Engineers, Inc. |