NCT03605641

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

An Open-Label, Single-Center Clinical Trial to Evaluate Selected Constituents in the Exhaled Breath and Room Air From the Use of E-vapor Products and Conventional Cigarettes Studied Under Residential, Office and Hospitality Environmental Conditions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Juul Labs, Inc. · Industry
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Second Hand Tobacco Smoke

Interventions

Type	Name	Description
OTHER	JUUL	JUUL Virginia Tobacco
OTHER	VUSE Solo	VUSE SOLO Original
OTHER	Conventional Cigarette	Subject preferred conventional cigarette

Timeline

• Start date: 2018-09-17
• Primary completion: 2018-12-02
• Completion: 2018-12-02
• First posted: 2018-07-30
• Last updated: 2021-06-14

Locations

1 site across 1 country: Canada