NCT04881942

Characterization of Selected Aerosol Constituents Levels in the Exhaled Breath of Adult e-Vapor Users

Characterization of Selected Aerosol Constituents Levels in the Exhaled Breath of Adult e-Vapor Users During Use of Four e-Vapor Products

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Altria Client Services LLC · Industry
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is an open-label, 4-way crossover study designed to estimate the nicotine, glycerin, propylene glycol, menthol, formaldehyde, acetaldehyde, and acrolein levels in exhaled breath samples during use of four MarkTen® XL e-vapor products. The study will enroll approximately 32 adult e-vapor-using subjects at one site in the United States in High Point, NC.

Detailed description

This is an open-label, 4-way crossover study designed to estimate the nicotine, glycerin, propylene glycol, menthol, formaldehyde, acetaldehyde, and acrolein levels in exhaled breath samples during use of four MarkTen® XL e-vapor products (which are no longer manufactured or sold commercially). The study will enroll approximately 32 adult e-vapor-using (with no more that 60% of either sex). Each of the 32 subjects will provide two exhaled breath samples (10 puffs for each sample) for all four test products. Subjects will make two visits to the site, one screening visit and one 4 day in-clinic visit to provide exhalation samples for four test products (one each day for 4 days). Subjects will also use their assigned test product ad libitum for 12 hours each day after the collection of exhaled breath samples. Subjects will be randomly assigned to a test product-use schedule at Visit 2, with one test product used per day. The anticipated study duration for each subject from screening through completion of all study participation will be approximately 34 days.

Conditions

• Tobacco Use

Interventions

Type	Name	Description
OTHER	e-Vapor Product A	e-Vapor product XL25F
OTHER	e-Vapor Product B	e-Vapor product XL40CB
OTHER	e-Vapor Product C	e-Vapor product XL35WM
OTHER	e-Vapor Product D	e-Vapor product XL40MB

Timeline

• Start date: 2017-03-27
• Primary completion: 2017-04-21
• Completion: 2018-01-26
• First posted: 2021-05-11
• Last updated: 2024-07-30
• Results posted: 2024-07-30

Locations

1 site across 1 country: United States