NCT00812279

Investigate the Exposure to Selected Smoke Constituents in Smokers Switching to Distillation Based Smoking Article

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Philip Morris Products S.A. · Industry
• Sex: All
• Age: 23 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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).

Conditions

• Smoking

Interventions

Type	Name	Description
OTHER	Distillation based smoking article (SMAR cigarette)	Subjects randomised to the SMAR arm will be trained by the site staff on the usage of SMAR and the corresponding lighter prior to smoking the first SMAR. Subjects will be allowed to smoke SMAR without any limit on consumption during the designated smoking times but have to request each SMAR from the site staff when they wish to smoke.
OTHER	conventional cigarette	Subjects randomised to the CC arm will continue to smoke their preferred CC brand during the exposure period. Subjects will be allowed to smoke without any limit on consumption during the designated smoking times but will have to request each CC from the site staff when they wish to smoke.
OTHER	smoking cessation	Subjects will not be allowed to smoke any cigarettes or to use any other nicotine/tobacco-containing products during the 5 days following randomisation.

Timeline

• Start date: 2008-11-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2008-12-22
• Last updated: 2019-11-07

Locations

1 site across 1 country: Poland