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

NCT02029196 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 408

Last updated 2017-03-21

Study results available
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Summary

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.

Conditions

  • Healthy Volunteers

Interventions

OTHER

E-vapour product

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

OTHER

Conventional cigarette

Smokers of conventional cigarettes who continue smoking conventional cigarettes.

Sponsors & Collaborators

  • Imperial Brands PLC

    lead INDUSTRY

Principal Investigators

  • Jim Bush, MD · Covance Clinical Research Unit, Springfield House, Hyde Street, Leeds LS2 9LH, UK

  • Girish Sharma, MD · Simbec Research, Merthyr Tydfil, CF48 4DR, UK

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2016-11-30
Completion
2016-11-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02029196 on ClinicalTrials.gov