Healthy Volunteers
Conditions
Brief summary
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.
Interventions
OTHERE-vapour product
Smokers of conventional cigarettes who switch to use an e-vapour product.
Smokers of conventional cigarettes who continue smoking conventional cigarettes.
Sponsors
Imperial Brands PLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 12 weeks | Frequency of adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Exhaled Carbon Monoxide | 12 weeks | Level of exhaled carbon monoxide at Week 12 |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| E-vapour Product (EVP) Subjects who switch from using conventional cigarettes to using an e-vapour product (EVP). | 306 |
| Conventional Cigarette (CC) Subjects who continue smoking their usual conventional cigarette (CC) brand. | 102 |
| Total | 408 |
Baseline characteristics
| Characteristic | E-vapour Product (EVP) | Conventional Cigarette (CC) | Total |
|---|---|---|---|
| Age, Continuous | 34.1 years STANDARD_DEVIATION 10.6 | 35.1 years STANDARD_DEVIATION 10.6 | 34.3 years STANDARD_DEVIATION 10.5 |
| Exhaled Carbon Monoxide (eCO) | 15.8 parts per million (ppm) STANDARD_DEVIATION 6.3 | 16.7 parts per million (ppm) STANDARD_DEVIATION 7.3 | 16.0 parts per million (ppm) STANDARD_DEVIATION 6.6 |
| Sex: Female, Male Female | 138 Participants | 44 Participants | 182 Participants |
| Sex: Female, Male Male | 168 Participants | 58 Participants | 226 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 271 / 306 | 74 / 102 |
| serious Total, serious adverse events | 5 / 306 | 0 / 102 |
Outcome results
Primary
Adverse Events
Frequency of adverse events
Time frame: 12 weeks
Population: All subjects who used the study product at least once.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| E-vapour Product (EVP) | Adverse Events | 1.60 percentage of adverse events |
| Conventional Cigarette (CC) | Adverse Events | 0.79 percentage of adverse events |
Secondary
Exhaled Carbon Monoxide
Level of exhaled carbon monoxide at Week 12
Time frame: 12 weeks
Population: Measure performed on subjects who completed the 12-week study (286 in the e-vapour product arm and 100 in the conventional cigarette arm).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| E-vapour Product (EVP) | Exhaled Carbon Monoxide | 8.99 parts per million (ppm) | Standard Deviation 6.33 |
| Conventional Cigarette (CC) | Exhaled Carbon Monoxide | 23.1 parts per million (ppm) | Standard Deviation 10.3 |