Clinical studies

Evaluating biological impact

Clinical studies using human subjects remain the gold standard for evaluating how people use a product and the biological consequences of doing so and are important for us to assess the reduced risk potential of products intended to present lower risks than cigarettes.

One of these tests, a pharmacokinetic (or PK) study, examines how quickly nicotine is taken from a product into the bloodstream. Although by no means the only factor involved, this can be crucial in determining whether a new product could be an adequate alternative for a smoker.

Laboratory analytical studies can determine what levels of toxicants are found in the emissions of new products, but human exposure will depend both on these emissions and how the products are used.

Biomarkers

When a chemical is taken into the body, it or its metabolic by-products can be measured in the blood, breath, saliva or urine. These biomarkers of exposure (BoEs) indicate how much of a particular substance has been taken into the body. Generally, the higher the levels found, the greater the exposure of the person to the original chemical. By comparing levels of BoEs when a person smokes cigarettes with those seen after they’ve switched to using a vapour product or tobacco heating product (THP), we can determine whether and to what extent use of the alternative product changes the amount of toxic chemicals or nicotine entering the body. In line with the US Institute of Medicine’s opinion that for a product to be considered a reduced harm product a consumer’s biological responses to using it should be similar to those of a former smoker¹, we also compare BoE levels of consumers using new category products with those in people who have quit smoking.

To assess the effects that chemicals have when inside the body, we can measure other indicators produced by the body in response to their presence. These indicators, called biomarkers of biological effect (BoBE), may be suggestive of early changes that could lead to disease development. We have identified BoBEs implicated in key processes (for example, inflammation and oxidative stress) that contribute to the development and progression of smoking-related diseases, such as cardiovascular disease and chronic obstructive pulmonary disease. Comparing BoBE levels can tell us whether switching from cigarettes to a novel product or quitting is likely to change the risk of developing a smoking-related disease.

PK studies on vapour

By examining how much nicotine a product delivers and how quickly it reaches the consumer’s bloodstream, a PK study can provide a preliminary indication of whether a product is likely to be acceptable to a smoker.

To evaluate how effective our Vype vapour products are at delivering nicotine, we conducted a clinical PK study to assess the nicotine delivery from different variants of Vype ePen products compared to a commercially available cigarette in healthy participants. The study was conducted in Merthyr Tydfil, Wales, by Simbec Research Limited. The scope of this study aimed to investigate the effect of nicotine salt, effect of nicotine concentration, and effect of device (technology) compared to a combustible cigarette.

Participants were experienced vapers that occasionally smoked cigarettes (dual users). Participants were confined in the clinic for 8 days and on each day, according to a randomisation programme, they were assigned a specific product. In brief, participants used the study products for 5 minutes and blood samples were collected at predetermined intervals for 120 minutes to track the nicotine concentration. For full details of the study design, we have registered the study in an open-access database (read more here ISRCTN55307091 ).

Our results show that Vype ePen 3, with high nicotine concentration delivers, nicotine similar to a combustible cigarette. Our results also show that nicotine salt drives better nicotine delivery. Lastly, Vype ePen 3, which has a better wick technology and higher nicotine per puff than ePen 2, had a significantly better nicotine delivery compared to its predecessor. "Results from this clinical study suggests that Vype ePen 3, particularly the vPro range, is a truly innovative product and a leading performing pod-mod system that can deliver nicotine as efficiently as a combustible cigarette", says Dr Mike McEwan, Senior Clinical Scientist.

Ground-breaking results from our glo clinical study

We have published the full results from our one-year clinical study of our Tobacco Heating Product (THP), glo.

The results showed that smokers switching exclusively to glo achieved significant and sustained improvements in several indicators of potential harm associated with early disease development compared to smokers who continued to smoke. This included lung disease, cancer, and cardiovascular disease (CVD).

The data, published in Internal and Emergency Medicine³, build upon the favourable changes reported at three and six-months⁴.  The improvements observed were sustained over the 12 months of the study, adding to the weight of evidence that supports glo as a less risky* alternative for adult smokers who would not otherwise quit.

Based on the early indicators of disease measured, smokers who switched completely to glo instead of continuing to smoke showed:
• Significant and sustained reduction in a biomarker with the potential to cause DNA damage associated with lung cancer
• Significant and sustained reduction in white blood cell count, an inflammatory marker associated with early development of CVD and other smoking-related diseases
• Sustained improvement in HDL cholesterol associated with reduced development of CVD
• Significant and sustained improvement in an indicator of lung health (FeNO)
• Significant and sustained improvement in a key indicator of oxidative stress, a process implicated in several smoking-related diseases, such as CVD

Read the full paper here.