Smoking Clinical Trial
Official title:
A Controlled, Randomised, Open-label, 3-arm Parallel Single-centre Confinement Study to Investigate Exposure to Selected Smoke Constituents in Smokers Switching From Conventional Cigarettes to SMAR Cigarettes for 5 Days
The overall purpose of this clinical study conducted in confinement under well-defined
conditions is to obtain initial data on the levels of human body exposure to selected smoked
constituents of the SMAR cigarette.
The main objective of this study is to compare the biomarkers of exposure to cigarette smoke
constituents in smokers switching to SMAR and to biomarkers in smokers of conventional
cigarettes (CC). The biomarkers of exposure will be measured in blood and urine samples
collected from the subjects. Moreover, the biomarkers in subjects smoking conventional or
SMAR cigarettes will be compared with those biomarkers in smokers who stop smoking for 5
days. The short term safety of this new product will also be evaluated.
This is a controlled, randomised, open-label, 3-arm parallel single centre confinement study
to investigate exposure to selected smoke constituents in smokers switching from CC to SMAR
for 5 days.
112 eligible subjects will be randomised to the 3 study arms: SMAR, conventional cigarettes
(CC) and smoking cessation (SC) in a 2:1:1 ratio.
Following the screening visit (within 4 weeks prior to the day of admission), the study will
be run over an 8-day period in a confined environment, consisting of the admission day (D-2),
a 2-day baseline period (D-1 and D0), and a 5-day exposure period (D1 to D5). Subjects will
be discharged in the morning of D6. From the discharge of the subject, a 7-day safety
follow-up period will be carried out (until D13).
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