NCT01970982

Reduced Exposure Study in Smokers Using the Tobacco Heating System 2.2 (THS 2.2) for 5 Days in a Confinement Setting

A Controlled, 3-arm Parallel Group Study to Demonstrate Reduction in Exposure to Smoke Constituents in Healthy Smokers Switching to THS 2.2 or to Smoking Abstinence, Compared to Conventional Cigarettes for 5 Days in Confinement

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 166 (actual)
• Sponsor: Philip Morris Products S.A. · Industry
• Sex: All
• Age: 23 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The overall goal of the study is to evaluate if the ad libitum use of the Tobacco Heating System 2.2 (THS 2.2) for 5 consecutive days by adult Japanese healthy smokers affects the levels of biomarkers of exposure for selected harmful and potentially harmful constituents (HPHCs) compared to smoking conventional cigarettes (CC) and smoking abstinence (SA).

Conditions

• Smoking

Interventions

Type	Name	Description
OTHER	Tobacco Heating System (THS 2.2)	THS 2.2 ad libitum for 5 days in confinement
OTHER	Smoking abstinence (SA)	SA for 5 days in confinement
OTHER	Conventional cigarette (CC)	Subject's own preferred brand of CC ad libitum for 5 days in confinement

Timeline

• Start date: 2013-07-01
• Primary completion: 2013-12-01
• Completion: 2014-07-01
• First posted: 2013-10-28
• Last updated: 2020-03-12
• Results posted: 2016-10-17

Locations

1 site across 1 country: Japan