A Study to Evaluate the Safety of Electronic Vapor Products for 2 Years

Fontem Ventures

Status

Completed

Conditions

Healthy Volunteers

Treatments

Device: EVP

Study type

Interventional

Funder types

Industry

Identifiers

NCT02143310

EVP G1 S3

Details and patient eligibility

About

Electronic Vapour Products (EVPs) is a relatively new class of consumer products that are otherwise known as electronic cigarettes devices/systems. These may look like conventional cigarettes but do not contain tobacco.

The 'vapour' produced by such devices typically consists of humectants (propylene glycol or glycerol), nicotine, water, and flavours.

This trial is to evaluate the safety and tolerability of an EVP over two years.

Enrollment

209 patients

Sex

All

Ages

21 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Subject who participated in the EVP G1 S2 study (S2)
Willingness to use the EVP provided by the sponsor for two years as the only nicotine containing product
No clinically significant abnormalities during the S2 study

Exclusion criteria

Subjects who have used nicotine replacement therapy during the S2 study
Subjects with relevant illness history
Subjects with history of drug or alcohol abuse
Subjects with lung function test or vital signs considered unsuitable Subjects who are trying to stop smoking
Female subjects who are pregnant, or unwilling to use acceptable contraceptive method for the duration of the study.