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Completed

NCT Number: NCT02029196

A Study to Evaluate the Safety Profile of an e-Vapour Product

Electronic Vapour Products (EVPs) is a relatively new class of consumer products that are otherwise known as electronic cigarettes or electronic nicotine delivery 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 of an e-vapour product.

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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

  • Body Mass Index (BMI) of 18-35kg/m2
  • Subjects must be established smokers
  • Subjects must have smoked five to 30 cigarettes per day for at least one year

Exclusion criteria

  • Subjects who have used nicotine replacement therapy within 14 days of the screening
  • Subjects who have donated blood within 12 months preceding study
  • Subjects with relevant illness history
  • Subjects positive for hepatitis or Human Immunodeficiency Virus (HIV)
  • 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

E-vapour product

Other

Smokers of conventional cigarettes who switch to use an e-vapour product.

Conventional cigarette

Other

Smokers of conventional cigarettes who continue smoking conventional cigarettes.

Primary outcomes

  1. Adverse Events

    Time frame: 12 weeks

    Frequency of adverse events

Secondary outcomes

  1. Exhaled Carbon Monoxide

    Time frame: 12 weeks

    Level of exhaled carbon monoxide at Week 12

Sponsors and collaborators

Lead sponsor

Imperial Brands PLC

Industry

Registry information

Official study title

A Randomised, Parallel Group, Multi-centre Study to Evaluate the Safety Profile of the ITG EVP G1 Product

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jan 7, 2014
Registry last updated
Mar 21, 2017

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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