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

NCT02029196 | Completed Results

• 1 other identifier: ITG EVP G1 S2
• Study Type: interventional
• Target: 408
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  Frequency of adverse events

  12 weeks

Secondary Outcomes (1)

• Exhaled Carbon Monoxide

  12 weeks

Study Arms (2)

e-vapour product (EVP)

EXPERIMENTAL

Subjects who switch from using conventional cigarettes to using an e-vapour product (EVP).

Other: E-vapour product

Conventional cigarette (CC)

ACTIVE COMPARATOR

Subjects who continue smoking their usual conventional cigarette (CC) brand.

Other: Conventional cigarette

Interventions

E-vapour product OTHER

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

e-vapour product (EVP)

Conventional cigarette OTHER

Smokers of conventional cigarettes who continue smoking conventional cigarettes.

Conventional cigarette (CC)

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Imperial Brands PLC: lead

Study Sites (2)

Covance Clinical Research Unit

Leeds, England, LS2 9HL, United Kingdom

Location

Simbec Research

Merthyr Tydfil, Wales, CF48 4DR, United Kingdom

Location

Results Point of Contact

• Title: Dr Ana Cravo
• Organization: Fontem Ventures

AnaMaria.Cravo@fontemventures.com

+441173322528

Study Officials

• Jim Bush, MD

  Covance Clinical Research Unit, Springfield House, Hyde Street, Leeds LS2 9LH, UK

  PRINCIPAL INVESTIGATOR

• Girish Sharma, MD

  Simbec Research, Merthyr Tydfil, CF48 4DR, UK

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2013
• First Posted: January 7, 2014
• Study Start: December 1, 2013
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: March 21, 2017
• Results First Posted: March 21, 2017

Record last verified: 2017-01

Locations

GB (2)