Study to Evaluate Constituents in Exhaled Breath and Room Air From Use of E-vapor Products and Conventional Cigarettes

NCT03605641 | Completed

• 1 other identifier: 755-00045
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Second Hand Tobacco Smoke

Keywords

E-Cigarettes; Conventional Cigarettes; JUUL; VUSE

Outcome Measures

Primary Outcomes (12)

• 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

  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)

Study Arms (3)

JUUL electronic cigarette

EXPERIMENTAL

JUUL electronic cigarette. Virginia Tobacco 5% tobacco-derived nicotine.

Other: JUUL

VUSE Solo electronic cigarette

ACTIVE COMPARATOR

Reynolds American International VUSE Solo electronic cigarette. Original flavor 4.8% tobacco-derived nicotine.

Other: VUSE Solo

Conventional cigarette

ACTIVE COMPARATOR

Canadian purchased, store bought (not hand-rolled) conventional full-flavored cigarettes of subjects' preference.

Other: Conventional Cigarette

Interventions

JUUL OTHER

JUUL Virginia Tobacco

JUUL electronic cigarette

VUSE Solo OTHER

VUSE SOLO Original

VUSE Solo electronic cigarette

Conventional Cigarette OTHER

Subject preferred conventional cigarette

Conventional cigarette

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must satisfy the following criteria before being enrolled into the study. Subjects must:
• 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.
• 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.
• Be a healthy male or female volunteer aged 21 - 65 years at the time of Screening Visit.
• Have a positive urine cotinine result at Screening (Screening Visit) of \>200 ng/ml.
• 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.
• Agree to abide by the study restrictions and return for the required assessments.
• 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.

You may not qualify if:

• Subjects must not:
• Report receiving any investigational product within 30 days prior to Screening (Screening Visit).
• Report any presence or history of a clinically significant disorder involving the cardiovascular, respiratory, renal, urologic, gastrointestinal, hepatic, immunologic, hematologic, endocrine, oncologic or neurologic system(s) or psychiatric disease as determined by the Investigator.
• Have any clinically significant results from laboratory tests, physical examinations, vital signs assessments, and electrocardiograms, as judged by the Investigator.
• Report a clinically significant illness during the 30 days prior to enrollment, as determined by the Investigator.
• Report a history of drug or alcohol addiction or abuse within the past 1 year.
• Have positive screen for alcohol or drugs of abuse at Screening (Screening Visit) or check-in at Clinical Visit 1.
• Have positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (anti-HCV).
• Have body mass index (BMI) greater than 40 kg/m2 or less than 18 kg/m2 at Screening (Screening Visit).
• Have used prescription anti-diabetic medication and/or insulin therapy within 12 months of Screening (Screening Visit).
• Have taken medication for depression or asthma within 6 months of Screening (Screening Visit).
• Have used prescription or over-the-counter bronchodilator medication (eg, inhaled or oral β-agonists) within 6 months of Screening (Screening Visit).
• Be breast-feeding or pregnant female subjects (confirmed by a positive pregnancy test). Female subjects, who are considered women of child bearing potential (WOCBP) and sexually active, must be willing and able to use an acceptable method of contraception from Screening (Screening Visit) through the end of the study.
• Be allergic to propylene glycol or glycerin.
• Be or have a first-degree relative (ie, parent, sibling or child) be a current employee of the Sponsor or Site.

Sponsors & Collaborators

• Juul Labs, Inc.: lead
• Inflamax Research Incorporated: collaborator

Study Sites (1)

Inflamax Research Limited

Mississauga, Ontario, L4W 1A4, Canada

Location

Related Publications (8)

• 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.

  PMID: 24365545 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.

  PMID: 24373737 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.

  PMID: 22672560 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.

  PMID: 24336346 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.

  PMID: 24732165 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.

  PMID: 28846634 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.

  PMID: 27734060 BACKGROUND

• ANSI/ASHRAE Standard 62.1-2016. Ventilation for Acceptable Indoor Air Quality. American Society of Heating, Refrigerating and Air-Conditioning Engineers, Inc.

  BACKGROUND

MeSH Terms

Conditions

Vaping

Condition Hierarchy (Ancestors)

Smoking; Behavior

Study Officials

• Peter Couroux, MD

  Inflamax Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2018
• First Posted: July 30, 2018
• Study Start: September 17, 2018
• Primary Completion: December 2, 2018
• Study Completion: December 2, 2018
• Last Updated: June 14, 2021

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)