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

April 10, 2019 updated by: Fontem Ventures BV

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

209

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • Leeds, England, United Kingdom, LS2 9LH
        • Covance Clinical Research Unit
    • Wales
      • Merthyr Tydfil, Wales, United Kingdom, CF48 4DR
        • Simbec Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EVP
Subject who use the EVP for up to 2 years
Device: EVP

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nicotine Withdrawal Symptoms
Time Frame: 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.
24 Months
Biomarkers of Exposure to Nicotine
Time Frame: 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).
24 months
Biomarkers of Effect
Time Frame: 24 months
Change from BL in the level of white blood cells.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fontem Ventures BV

Investigators

  • Principal Investigator: Jim Bush, MD, Covance Clinical Research Unit

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

December 29, 2016

Study Completion (Actual)

December 29, 2016

Study Registration Dates

First Submitted

May 9, 2014

First Submitted That Met QC Criteria

May 17, 2014

First Posted (Estimate)

May 21, 2014

Study Record Updates

Last Update Posted (Actual)

July 1, 2019

Last Update Submitted That Met QC Criteria

April 10, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • EVP G1 S3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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