NCT01959932

Reduced Exposure Study in Smokers Using THS 2.2 With 5 Days in a Confinement Setting.

A Randomized, Controlled, Open-label, 3-arm Parallel Group, Single-center Study to Demonstrate Reductions in Exposure to Selected Smoke Constituents in Smoking, Healthy Subjects Switching to the Tobacco Heating System 2.2 (THS 2.2) or Smoking Abstinence, Compared to Continuing to Use Conventional Cigarettes, for 5 Days in Confinement.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 169 (actual)
• Sponsor: Philip Morris Products S.A. · Industry
• Sex: All
• Age: 21 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 days by adult healthy smokers results in a reduction in the levels of biomarkers of exposure (BoExp) 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: 2013-06-01
• Primary completion: 2013-09-01
• Completion: 2014-06-01
• First posted: 2013-10-10
• Last updated: 2020-03-12
• Results posted: 2016-10-13

Locations

1 site across 1 country: Poland