NCT02641587

Reduced Exposure Study Using the CHTP 1.2 With 5 Days in a Confinement Setting Followed by 85 Days in an Ambulatory Setting.

A Randomized, Controlled, Open-label, 2-arm Parallel Group, Single Center Study to Demonstrate Reductions in Exposure to Selected Smoke Constituents in Healthy Smokers Switching to the Carbon Heated Tobacco Product 1.2 (CHTP 1.2), Compared to Continuing to Use Combustible Cigarettes, for 5 Days in Confinement Followed by 85 Days in an Ambulatory Setting.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: Philip Morris Products S.A. · Industry
• Sex: All
• Age: 28 Years
• Healthy volunteers: Accepted

Summary

The overall goal of the study is to demonstrate reduction in the levels of biomarkers of exposure (BoExp) to selected harmful and potentially harmful constituents (HPHCs) identified in cigarettes and to obtain safety information in healthy adult smokers switching to the Carbon Heated Tobacco Product 1.2 (CHTP 1.2) as compared to subjects continuing smoking cigarettes (CC) in a confinement setting for 5 days (exclusive use) followed by an ambulatory setting of 85 days.

Conditions

• Smoking

Interventions

Type	Name	Description
OTHER	CHTP 1.2	Ad libitum use of the CHTP 1.2 for 5 days in confinement followed by 85 days in an ambulatory setting.
OTHER	CC	Ad libitum use of subject's own preferred non-menthol brand of CC for 5 days in confinement followed by 85 days in an ambulatory setting.

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-08-01
• Completion: 2017-07-01
• First posted: 2015-12-29
• Last updated: 2023-02-21
• Results posted: 2019-03-06

Locations

1 site across 1 country: Poland