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Clinical Assessment

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Clinical assessment is the cornerstone of Philip Morris International’s assessment program. Clinical studies assess whether the reduction in the formation of harmful and potentially harmful constituents (HPHCs) measured in the laboratory leads to a reduction in HPHC exposure under real-use conditions when an adult smoker switches to the product. Furthermore, they demonstrate whether switching from cigarettes to a candidate reduced-risk product has a beneficial effect on a smoker’s health profile. Clinical studies also help determine the extent to which adult smokers would find the product an acceptable alternative to cigarettes.

Clinical assessment is the cornerstone of Philip Morris International’s assessment program. Clinical studies assess whether the reduction in the formation of harmful and potentially harmful constituents (HPHCs) measured in the laboratory leads to a reduction in HPHC exposure under real-use conditions when an adult smoker switches to the product. Furthermore, they demonstrate whether switching from cigarettes to a candidate reduced-risk product has a beneficial effect on a smoker’s health profile. Clinical studies also help determine the extent to which adult smokers would find the product an acceptable alternative to cigarettes.

PMI has completed eight clinical studies on its novel IQOS tobacco heating system (version THS2.2) with a total of almost 900 adult smokers to date. PMI is also conducting clinical trials on its other candidate reduced risk products. The information about the eight IQOS clinical studies as well as other relevant ongoing studies is summarized below.

Four pharmacokinetic and pharmacodynamic clinical studies investigating nicotine uptake, suppression of the urge to smoke, and subjective effects compared to cigarettes:

The results showed that IQOS was comparable to cigarettes in terms of nicotine uptake and ability to suppress the urge to smoke.

Two 5-day clinical studies in confinement investigating exposure reduction to harmful and potentially harmful constituents (HPHCs):

The results showed that the reduction in exposure to HPHCs measured in smokers who switched to IQOS approached the effect observed in smokers who quit smoking for the duration of the study.

Two 3-month clinical studies investigating exposure reduction to HPHCs over a longer period of time in a more real-life setting:

The results showed that the reduction in exposure to HPHCs measured in smokers who switched to IQOS approached the effect observed in smokers who quit smoking for the duration of the study. In both of these 3-month studies, PMI also measured six clinical risk markers. These clinical risk markers are reflective of disease mechanisms known to be affected by smoking and to reverse upon cessation.

In addition to the eight completed studies, PMI is conducting longer term clinical studies to measure clinical risk markers known to be affected by smoking, and reverse upon cessation (so called “Exposure Response Study”). The study is designed to measure the reversal of clinical risk markers when smokers switch to IQOS over a 12-month period. The study is divided into two consecutive 6-month phases, focusing first on markers known to reverse more quickly and then on respiratory function, which takes more time. These results will be benchmarked against those of the Smoking Cessation Response study (below).

Close to 1,000 adult participants have enrolled in the study, and all participants have completed the first 6-month phase. More than 80% of the adult participants enrolled have agreed to continue for the full year. Results will be available in 2018.

For more details about the studies, visit:

To establish a one-year “gold standard” of cessation for assessing candidate reduced risk products, PMI is conducting the Smoking Cessation Response study across a number of countries, which measures the reversal of clinical risk markers when adult smokers quit smoking for one year.

Over 1,100 adult participants have enrolled. Results will be available in 2018.

For more details, visit:

To learn more about PMI’s clinical studies, read the following peer-reviewed publications:

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