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

Not Applicable

Completed

• Conditions: Healthy Volunteers
• Interventions: Device: EVP

• Registration Number: NCT02143310
• Lead Sponsor: Fontem Ventures BV

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-09
• Study First Submitted QC: 2014-05-17
• Study First Posted: 2014-05-21
• Primary Completion: 2016-12-29
• Study Completion: 2016-12-29
• Results First Submitted: 2018-03-15
• Status Verified: 2019-04
• Results First Submitted QC: 2019-04-10
• Last Update Submitted: 2019-04-10
• Results First Posted: 2019-07-01
• Last Update Posted: 2019-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 209

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EVP	EVP	Subject who use the EVP for up to 2 years

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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).
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.
Biomarkers of Effect	24 months	Change from BL in the level of white blood cells.

Trial Locations

Locations (2)

Simbec Research; 🇬🇧 Merthyr Tydfil, Wales, United Kingdom

Covance Clinical Research Unit; 🇬🇧 Leeds, England, United Kingdom