NCT01970995

Reduced Exposure Study Using THS 2.2 Menthol With 5 Days in a Confinement Setting and 85 Days in an Ambulatory Setting

A Randomized, Controlled, Multi-center Study to Demonstrate Reductions in Exposure to Selected Smoke Constituents in Smokers Switching to THS 2.2 Menthol or Smoking Abstinence Compared to Smoking Menthol Conventional Cigarettes, for 90 Days

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Philip Morris Products S.A. · Industry
• Sex: All
• Age: 23 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The main goal of the study is to evaluate if the ad libitum use of the THS 2.2 Menthol (mTHS 2.2) for 5 days in confinement and after 85 days of product use in an ambulatory setting, by Japanese adult healthy smokers results in a reduction in the levels of biomarkers of exposure for selected harmful and potentially harmful smoke constituents (HPHCs) compared to smokers continuing smoking their own preferred brand of menthol conventional cigarette (mCC) and smoking abstinence (SA). Smokers who remained abstinent from SA were used as a benchmark to provide context to the exposure reduction.

Conditions

• Smoking

Interventions

Type	Name	Description
OTHER	THS 2.2 Menthol (mTHS 2.2)	THS 2.2 Menthol ad libitum for 5 days in confinement prolonged by 85 days in an ambulatory setting
OTHER	Smoking Abstinence (SA)	SA for 5 days in confinement prolonged by 85 days in an ambulatory setting
OTHER	Menthol Conventional Cigarette (mCC)	Subject's own preferred brand of mCC ad libitum for 5 days in confinement prolonged by 85 days in an ambulatory setting

Timeline

• Start date: 2013-08-01
• Primary completion: 2014-07-01
• Completion: 2014-11-01
• First posted: 2013-10-28
• Last updated: 2020-03-23
• Results posted: 2017-02-07

Locations

1 site across 1 country: Japan