NCT02143310

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
209

participants targeted

Target at P75+ for not_applicable healthy-volunteers

Timeline
Completed

Started May 2014

Longer than P75 for not_applicable healthy-volunteers

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

May 9, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 21, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2016

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

July 1, 2019

Completed
Last Updated

July 1, 2019

Status Verified

April 1, 2019

Enrollment Period

2.7 years

First QC Date

May 9, 2014

Results QC Date

March 15, 2018

Last Update Submit

April 10, 2019

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (4)

  • Blood Pressure

    Sitting systolic blood pressure (mmHg)

    24 months

  • Electrocardiogram (ECG): PR Interval

    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

    Forced Vital Capacity (FVC)

    24 months

  • Clinical Laboratory Parameters

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

    24 months

Secondary Outcomes (3)

  • Nicotine Withdrawal Symptoms

    24 Months

  • Biomarkers of Exposure to Nicotine

    24 months

  • Biomarkers of Effect

    24 months

Study Arms (1)

EVP

EXPERIMENTAL

Subject who use the EVP for up to 2 years

Device: EVP

Interventions

EVPDEVICE
EVP

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Covance Clinical Research Unit

Leeds, England, LS2 9LH, United Kingdom

Location

Simbec Research

Merthyr Tydfil, Wales, CF48 4DR, United Kingdom

Location

Results Point of Contact

Title
Tanvir Walele
Organization
FontemVentures
tanvir.walele@fontemventures.com
01779337589

Study Officials

  • Jim Bush, MD

    Covance Clinical Research Unit

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2014

First Posted

May 21, 2014

Study Start

May 1, 2014

Primary Completion

December 29, 2016

Study Completion

December 29, 2016

Last Updated

July 1, 2019

Results First Posted

July 1, 2019

Record last verified: 2019-04

Locations

GB(2)