Evaluation of the Tobacco Heating System 2.2. Part 8: 5-Day randomized reduced exposure clinical study in Poland.
The Tobacco Heating System (THS) 2.2, a candidate Modified Risk Tobacco Product (MRTP), is designed to heat tobacco without burning it. Tobacco is heated in order to reduce the formation of harmful and potentially harmful constituents (HPHC), and reduce the consequent exposure, compared with combustible cigarettes (CC). In this 5-day exposure, controlled, parallel-group, open-label clinical study, 160 smoking, healthy subjects were randomized to three groups and asked to: (1) switch from CCs to THS 2.2 (THS group; 80 participants); (2) continue to use their own non-menthol CC brand (CC group; 41 participants); or (3) to refrain from smoking (smoking abstinence (SA) group; 39 participants). Biomarkers of exposure, except those associated with nicotine exposure, were significantly reduced in the THS group compared with the CC group, and approached the levels observed in the SA group. Increased product consumption and total puff volume were reported in the THS group. However, exposure to nicotine was similar to CC at the end of the confinement period. Reduction in urge-to-smoke was comparable between the THS and CC groups and THS 2.2 product was well tolerated.
PMI R&D, Philip Morris Products S.A. (Part of Philip Morris International Group of Companies), Neuchâtel, Switzerland. Electronic address: Christelle.Haziza@pmi.com.
Christelle
C
Haziza
PMI R&D, Philip Morris Products S.A. (Part of Philip Morris International Group of Companies), Neuchâtel, Switzerland.
Guillaume
G
de La Bourdonnaye
PMI R&D, Philip Morris Products S.A. (Part of Philip Morris International Group of Companies), Neuchâtel, Switzerland.
Dimitra
D
Skiada
PMI R&D, Philip Morris Products S.A. (Part of Philip Morris International Group of Companies), Neuchâtel, Switzerland.
Jacek
J
Ancerewicz
PMI R&D, Philip Morris Products S.A. (Part of Philip Morris International Group of Companies), Neuchâtel, Switzerland.
Gizelle
G
Baker
PMI R&D, Philip Morris Products S.A. (Part of Philip Morris International Group of Companies), Neuchâtel, Switzerland.
Patrick
P
Picavet
PMI R&D, Philip Morris Products S.A. (Part of Philip Morris International Group of Companies), Neuchâtel, Switzerland.
Frank
F
Lüdicke
D000328:Adult; D000336:Aerosols; D015415:Biomarkers / Q000097:blood / Q000652:urine; D003257:Consumer Product Safety; D019388:Cytochrome P-450 CYP1A2 / Q000378:metabolism; D066300:Electronic Nicotine Delivery Systems / Q000009:adverse effects*; D004867:Equipment Design; D005260:Female; D040261:Harm Reduction; D006358:Hot Temperature; D006801:Humans; D019570:Inhalation Exposure / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D011044:Poland; D018570:Risk Assessment; D012906:Smoke / Q000009:adverse effects*; D012907:Smoking / Q000009:adverse effects* / Q000097:blood / Q000652:urine; D016540:Smoking Cessation / Q000379:methods; D000074606:Smoking Prevention; D013997:Time Factors; D019460:Tobacco Industry; D062789:Tobacco Products / Q000633:toxicity*; D018675:Toxicity Tests / Q000379:methods; D055815:Young Adult
D000336:Aerosols; D015415:Biomarkers; D012906:Smoke; C504573:CYP1A2 protein, human; D019388:Cytochrome P-450 CYP1A2
Biomarkers of exposure; Conventional cigarettes; Harmful and potentially harmful constituents; Randomized study; Smoking abstinence; Tobacco heating system