NCT02396381

Evaluation of Biological and Functional Changes in Healthy Smokers After Switching to THS 2.2 for 26 Weeks

A Randomized, Controlled, 2-arm Parallel Group, Multi-center Study, to Evaluate Biological and Functional Changes in Healthy Smokers Switching to Tobacco Heating System 2.2 (THS 2.2) Compared to Continuing Smoking Conventional Cigarettes for 26 Weeks in an Ambulatory Setting

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,039 (actual)
• Sponsor: Philip Morris Products S.A. · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Accepted

Summary

The aim of the study is to demonstrate clinical, biological and functional health changes in smokers switching to the candidate modified risk tobacco product: Tobacco Heating System 2.2 (THS 2.2) as compared to smokers continuing smoking their conventional cigarettes (CC) over a 26-week period. To characterize the study as successful, at least 5 clinical risk endpoints should move in the direction of smoking cessation and these results would be statistically significant. The main analysis will be defined a priori (using the Hailperin-Ruger approach) and will be made between THS 2.2 use and CC use as "per actual product used" and product use categories.

Detailed description

The clinical, biological and functional endpoints to be measured in this study ("smoker's health profile") may characterize the modification of risk of smoking-related diseases. Clinical risk endpoint to be assessed are selected based on a) their association to smoking-related diseases b) their association to smoking status, c) their reversibility upon smoking cessation, and d) their suitability to be measured with valid and robust methods in clinical studies. The biological markers, functional markers and biomarkers of exposure (BoExp) with the strongest scientific evidence will constitute the 'smoker's health profile' and will be measured as the primary objective of the study. Additional endpoints involved in the mechanistic of smoking-related diseases will be studied to provide additional scientific evidence to strengthen the primary objective. The study will provide a perspective of product usage in a "real world setting" where smoking CC in addition to THS 2.2 may be expected.

Conditions

• Smoking

Interventions

Type	Name	Description
OTHER	THS 2.2	Ad libitum use of THS 2.2 in an ambulatory setting for 26 weeks
OTHER	CC	Ad libitum use of CC in an ambulatory setting for 26 weeks

Timeline

• Start date: 2015-03-12
• Primary completion: 2016-09-13
• Completion: 2017-08-01
• First posted: 2015-03-24
• Last updated: 2023-01-26
• Results posted: 2019-08-21

Locations

19 sites across 1 country: United States