Clinical Assessment

Our clinical studies at a glance

Our most relevant clinical studies related to our smoke-free portfolio are shown below.

About consumer acceptance and the safety of our products

ID	Study title	Status
NCT01967732	Nicotine Pharmacokinetic Profile and Safety of the Tobacco Heating System 2.2 (THS 2.2)	Completed
NCT01967706	Nicotine Pharmacokinetic Profile and Safety of the Tobacco Heating System 2.2 Menthol (THS 2.2 Menthol)	Completed
NCT01959607	Nicotine Pharmacokinetic Profile and Safety of the Tobacco Heating System 2.2 (THS 2.2)	Completed
NCT01967719	Nicotine Pharmacokinetic Profile and Safety of the Tobacco Heating System 2.2 Menthol (THS 2.2 Menthol)	Completed
NCT02466412	Nicotine Pharmacokinetic Profile of the CHTP 1.1 M	Completed
NCT02643693	User Acceptability of P3L	Completed
NCT02532374	Nicotine Pharmacokinetic and Pharmacodynamics Profile, Safety and Tolerability of P3L	Completed
NCT03369340	Nicotine Pharmacokinetics and Pharmacodynamics, Safety and Tolerability of P3P	Completed
NCT03379740	Study to Investigate the Nicotine Pharmacokinetic Profiles and Pharmacodynamic Effects of P4M3 Variants	Completed

Measuring markers of harmful compounds in participants’ samples

ID	Study title	Status
NCT01970982	Reduced Exposure Study in Smokers Using the Tobacco Heating System 2.2 (THS 2.2) for 5 Days in a Confinement Setting	Completed
NCT01959932	Reduced Exposure Study in Smokers Using THS 2.2 With 5 Days in a Confinement Setting.	Completed
NCT01989156	Reduced Exposure Study Using THS 2.2 Menthol With 5 Days in a Confinement Setting Followed by 86 Days in an Ambulatory Setting	Completed
NCT01970995	Reduced Exposure Study Using THS 2.2 Menthol With 5 Days in a Confinement Setting and 85 Days in an Ambulatory Setting	Completed
NCT02641587	Reduced Exposure Study Using the CHTP 1.2 With 5 Days in a Confinement Setting Followed by 85 Days in an Ambulatory Setting.	Completed
NCT02503254	Reduced Exposure Study Using CHTP 1.0 During 5 Days in Confinement.	Completed
NCT03550989	Real-Life Passive Exposure Assessment of Platform 1	Active, not recruiting

Collecting information about the risk of smoking-related diseases

ID	Study title	Status
NCT02396381	Evaluation of Biological and Functional Changes in Healthy Smokers After Switching to THS 2.2 for 26 Weeks	Completed
NCT02649556	A 26-week Extension of the ZRHR-ERS-09-US Study Evaluating Biological and Functional Changes in Healthy Smokers After Switching to THS 2.2	Completed
NCT02432729	A Smoking Cessation Study to Understand the Biological and Functional Changes After One Year of Smoking Cessation (RIBESC)	Completed

These trials are registered on www.clinicaltrials.gov, the most comprehensive clinical registry available today.

The size and duration of these studies vary considerably – from a few days in our pharmacokinetics studies, to up to one year in our Exposure Response Study where the goal is to observe near real-world product usage and favorable changes in risk markers linked to smoking related diseases. These studies are performed either in confinement, where participants are required to stay in the clinic, or in an ambulatory setting, where participants check-in at the clinic at regular intervals but otherwise live a normal life at home or at work. We also have studies that apply a combination of the two, starting with a short period in the clinic, followed by regular visits.

Our studies are conducted according to Good Clinical Practice and we also publish the results of our studies as they become available at www.clinicaltrials.gov and in peer-reviewed journals.

How does PMI conduct clinical trials

Long-Term Assessment

Conferences

Our posters and presentations shown at conferences around the world

Discover our preliminary findings