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Completed

NCT Number: NCT02143310

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

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Key information

Conditions

Healthy Volunteers

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Covance Clinical Research Unit, Leeds, England, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EVP

Device

Primary outcomes

  1. Blood Pressure

    Time frame: 24 months

    Sitting systolic blood pressure (mmHg)

  2. 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.

  3. Lung Function Tests

    Time frame: 24 months

    Forced Vital Capacity (FVC)

  4. Clinical Laboratory Parameters

    Time frame: 24 months

    High density lipoprotein (HDL) cholesterol, change from baseline (BL)

Secondary outcomes

  1. 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.

  2. 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).

  3. Biomarkers of Effect

    Time frame: 24 months

    Change from BL in the level of white blood cells.

Sponsors and collaborators

Lead sponsor

Fontem Ventures BV

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 21, 2014
Registry last updated
Jul 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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