A study to evaluate VOCs in exhaled breath in healthy volunteers
Research type
Research Study
Full title
An Exploratory Research Study to Evaluate the Concentration of Volatile Organic Compounds in Exhaled Breath Following Use of the Logic Compact E-cigarette and Tobacco Flavour Pod.
IRAS ID
271631
Contact name
Ezanul Wahab
Contact email
Sponsor organisation
JT International SA
ISRCTN Number
ISRCTN83014658
Duration of Study in the UK
0 years, 1 months, 5 days
Research summary
This study is an open-label, non-randomised research study.
The purpose of this exploratory research study is to investigate, measure and analyse the different levels of certain chemicals (known as volatile organic compounds) which are used to make up e-liquids or are produced when the e-liquid is heated by the device. Additionally, the study will provide some early high-level data from a small group of participants to investigate the exposure of the users to these particular chemicals. These chemicals will be measured in the breath after using the e-cigarette device on 4 occasions (known as product use periods) with 2 different types of vaping technique i.e. mouth holding and inhalation.
The study will investigate an already marketed e-cigarette product:Logic Compact E-cigarette and Tobacco flavour pod, nicotine concentration: 12 (mg)/(mL).
This study will be conducted in 6 healthy volunteers (male and female) who are regular users of e-cigarette devices or current smokers (excluding those who use NRTs or are menthol cigarette users). There are 4 product use periods in total (a total of 1 day duration) where participants will use the e-cigarette under different vaping regimes i.e. mouth-holding or inhalation. At each product use period, participants will be required to exhale into a device which will measure the level of different VOCs in the breath.
REC name
London - South East Research Ethics Committee
REC reference
20/HRA/2098
Date of REC Opinion
30 Jun 2020
REC opinion
Further Information Favourable Opinion