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

Study Overview
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Brief Summary
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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.

Official Title
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A Multi-Centre Study to Evaluate the Safety of Use of Electronic Vapour Products for Two Years

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Device: EVP


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EVP<br>Subject who use the EVP for up to 2 years | Device: EVP<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure | Sitting systolic blood pressure (mmHg) | 24 months | 
| 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. | 24 months | 
| Lung Function Tests | Forced Vital Capacity (FVC) | 24 months | 
| Clinical Laboratory Parameters | High density lipoprotein (HDL) cholesterol, change from baseline (BL) | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 24 Months | 
| 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). | 24 months | 
| Biomarkers of Effect | Change from BL in the level of white blood cells. | 24 months |