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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02143310
• Other study ID #: EVP G1 S3
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: December 29, 2016

Study information

• Verified date: April 2019
• Source: Fontem Ventures BV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 209
• Est. completion date: December 29, 2016
• Est. primary completion date: December 29, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Device:
• EVP

Locations

Country	Name	City	State
United Kingdom	Covance Clinical Research Unit	Leeds	England
United Kingdom	Simbec Research	Merthyr Tydfil	Wales

Sponsors (1)

Lead Sponsor	Collaborator
Fontem Ventures BV

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Pressure	Sitting systolic blood pressure (mmHg)	24 months
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.	24 months
Primary	Lung Function Tests	Forced Vital Capacity (FVC)	24 months
Primary	Clinical Laboratory Parameters	High density lipoprotein (HDL) cholesterol, change from baseline (BL)	24 months
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.	24 Months
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).	24 months
Secondary	Biomarkers of Effect	Change from BL in the level of white blood cells.	24 months