Healthy Volunteers
Conditions
Brief summary
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.
Interventions
DEVICEEVP
Sponsors
Fontem Ventures BV
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure | 24 months | Sitting systolic blood pressure (mmHg) |
| Electrocardiogram (ECG): PR Interval | 24 months | In electrocardiography, the PR interval is the period that extends from the beginning of the P wave (the onset of atrial depolarization) until the beginning of the QRS complex. Variations in the PR interval can be associated with certain medical conditions. |
| Lung Function Tests | 24 months | Forced Vital Capacity (FVC) |
| Clinical Laboratory Parameters | 24 months | High density lipoprotein (HDL) cholesterol, change from baseline (BL) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biomarkers of Exposure to Nicotine | 24 months | The exposure to nicotine was measured by quantifying the change from BL in the amount of nicotine equivalents excreted in urine in 24-hours (AE24h). |
| Biomarkers of Effect | 24 months | Change from BL in the level of white blood cells. |
| Nicotine Withdrawal Symptoms | 24 Months | Nicotine withdrawal symptoms were measured using the revised Minnesota Nicotine Withdrawal Scale (MWS-R) questionnaire. Extended total scores were used, i.e. the sum of the scores of all 15 questions of the questionnaire. Symptoms (e.g. angry, irritable, frustrated, depressed, restless, insomnia) were rated from 0 (none) to 4 (severe). Extended total scores may range from 0 to a maximum of 60. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| EVP Users Subjects who switch to use the EVP for up to 2 years
EVP | 209 |
| Total | 209 |
Baseline characteristics
| Characteristic | EVP Users | — |
|---|---|---|
| Age, Continuous | 36.6 years STANDARD_DEVIATION 10.2 | — |
| Biomarkers of exposure to nicotine | 8.39 mg STANDARD_DEVIATION 7.19 | — |
| Carboxyhemoglobin | 5.09 Percent of total hemoglobin STANDARD_DEVIATION 2.04 | — |
| Exhaled carbon monoxide (CO) | 13.6 ppm STANDARD_DEVIATION 11.1 | — |
| HDL cholesterol | 1.41 mmol/L | — |
| Level of white blood cells | 7.3 G/L | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 94 Participants | — |
| Sex: Female, Male Male | 115 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 209 |
| other Total, other adverse events | 60 / 209 |
| serious Total, serious adverse events | 7 / 209 |
Outcome results
Primary
Blood Pressure
Sitting systolic blood pressure (mmHg)
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EVP Users | Blood Pressure | 122.4 mmHg | Standard Deviation 11.1 |
Primary
Clinical Laboratory Parameters
High density lipoprotein (HDL) cholesterol, change from baseline (BL)
Time frame: 24 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| EVP Users | Clinical Laboratory Parameters | -0.03 mmol/L |
Primary
Electrocardiogram (ECG): PR Interval
In electrocardiography, the PR interval is the period that extends from the beginning of the P wave (the onset of atrial depolarization) until the beginning of the QRS complex. Variations in the PR interval can be associated with certain medical conditions.
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EVP Users | Electrocardiogram (ECG): PR Interval | 152.3 ms | Standard Deviation 18.7 |
Primary
Lung Function Tests
Forced Vital Capacity (FVC)
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EVP Users | Lung Function Tests | 4.369 Liters | Standard Deviation 1.007 |
Secondary
Biomarkers of Effect
Change from BL in the level of white blood cells.
Time frame: 24 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| EVP Users | Biomarkers of Effect | -0.31 G/L |
Secondary
Biomarkers of Exposure to Nicotine
The exposure to nicotine was measured by quantifying the change from BL in the amount of nicotine equivalents excreted in urine in 24-hours (AE24h).
Time frame: 24 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| EVP Users | Biomarkers of Exposure to Nicotine | 0.85 mg |
Secondary
Nicotine Withdrawal Symptoms
Nicotine withdrawal symptoms were measured using the revised Minnesota Nicotine Withdrawal Scale (MWS-R) questionnaire. Extended total scores were used, i.e. the sum of the scores of all 15 questions of the questionnaire. Symptoms (e.g. angry, irritable, frustrated, depressed, restless, insomnia) were rated from 0 (none) to 4 (severe). Extended total scores may range from 0 to a maximum of 60.
Time frame: 24 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EVP Users | Nicotine Withdrawal Symptoms | 3.3 score on a scale | Standard Deviation 4.2 |