Our clinical studies provide human data on the use and acceptance of our smoke-free products as well as their potential to reduce exposure to harmful chemicals and the potential to reduce the risk of smoking-related diseases as compared to continued smoking.
In order to assess if a product is likely to be acceptable to adult smokers, we conduct Pharmacokinetics/Pharmacodynamics clinical studies
For adult smokers to accept our smoke-free products as viable alternatives to smoking, it is important that they experience a satisfaction similar to that delivered by cigarettes. Taste, sensory experience, ritual and nicotine delivery are important in this context. Our pharmacokinetic studies measure how much nicotine from single smoke-free product is absorbed in the body, and how long it remains present. We also measure the subject’s urge to smoke as well as the subject’s first impression on how they experience the product overall.
Clinical studies can help us understand the levels of HPHCs a subject has been exposed to
Our smoke-free products are designed to generate significantly lower levels of HPHCs and PMI’s Reduced Exposure Studies verify that smokers who switch to our smoke-free products, are actually exposed to less HPHCs compared to those who continue to smoke cigarettes in a clinical setting. The subject’s exposure to HPHCs after switching to one of our smoke-free products can be assessed by determining the levels of breakdown products resulting from these compounds, which are known as biomarkers of exposure.
Clinical studies can provide information about the risk of developing smoking-related diseases
Does the reduction in exposure measured in our Reduced Exposure Studies translate into favorable health effects? We aim to answer this question through Exposure Response Studies.
We have completed a 12-month study with Platform 1 and we released the results for the first six months. The data from the second six months of the study are currently being analyzed.
An example of such a measurement endpoint is the level of blood cholesterol. It has previously been described in medical literature that smoking causes a decrease in HDL cholesterol and an increase in LDL cholesterol. Quitting smoking can help to reverse the imbalance between HDL and LDL. In our studies, we investigated if switching to smoke-free products restores this balance, among other parameters indicative of a favorable change in risk of study participants.
All of our clinical studies are conducted in partnership with Contract Research Organizations (CROs), and are conducted under Good Clinical Practice (GCP). We register all our studies on www.clinicaltrials.gov and regularly publish the latest data from our studies in peer-reviewed scientific publications.