Our most relevant clinical studies related to our smoke-free portfolio are shown below.
About consumer acceptance and the safety of our products
|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 ||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
|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
|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.
Read more on the International Conference of Harmonization’s Good Clinical Practice
International Conference of Harmonization’s Good Clinical Practice Current Step 4 version 10 June 1996