A Study to Evaluate the Safety Profile of an e-Vapour Product

Imperial Brands

Status

Completed

Conditions

Healthy Volunteers

Treatments

Other: E-vapour product

Other: Conventional cigarette

Study type

Interventional

Funder types

Industry

Identifiers

NCT02029196

ITG EVP G1 S2

Details and patient eligibility

About

Electronic Vapour Products (EVPs) is a relatively new class of consumer products that are otherwise known as electronic cigarettes or electronic nicotine delivery 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 of an e-vapour product.

Enrollment

408 patients

Sex

All

Ages

21 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Body Mass Index (BMI) of 18-35kg/m2
Subjects must be established smokers
Subjects must have smoked five to 30 cigarettes per day for at least one year

Exclusion criteria

Subjects who have used nicotine replacement therapy within 14 days of the screening
Subjects who have donated blood within 12 months preceding study
Subjects with relevant illness history
Subjects positive for hepatitis or Human Immunodeficiency Virus (HIV)
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.