NCT02649556

A 26-week Extension of the ZRHR-ERS-09-US Study Evaluating Biological and Functional Changes in Healthy Smokers After Switching to THS 2.2

A 26-week Extension Study to Determine the Biological and Functional Changes in Healthy Smokers Who Switched From Conventional Cigarettes (CC) to Tobacco Heating System 2.2 (THS 2.2) Compared to Those Who Continued to Smoke CC in the ZRHR-ERS-09-US Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 672 (actual)
• Sponsor: Philip Morris Products S.A. · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Accepted

Summary

The objective of the ZRHR-ERS-09-EXT-US study is to further assess the effect of the Tobacco Heating System 2.2 (THS 2.2), a candidate Modified Risk Tobacco Product, compared to conventional cigarettes (CC) on the components of the "smokers' health profile" for a prolonged period of 26 weeks, providing additional information to the results of the original study ZRHR-ERS-09-US of 26-week exposure (NCT02396381). In total, the ZRHR-ERS-09-EXT-US study will extend the exposure period to 52 weeks.

Detailed description

The ZRHR-ERS-09-EXT-US study is a 26-week extension of the original study ZRHR-ERS-09-US. The subjects in the Full Analysis Set - As Exposed (FAS-EX) included subjects for combined analyses from the original six month study (ZRHR-ERS-09-US ) who did not enter the extension study (ZRHR-ERS-09-EXT-US). This study was conducted as a separate investigation, as a follow-up of the randomized exposure period of the original study, extending the exposure from Week 26 (Visit 10 \[V10\]) to Week 52 (Visit 16 \[V16\]), and using the same sites. Subjects continued to use the product they were randomized to in the original study ZRHR-ERS-09-US (THS 2.2 arm or CC arm).

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. The subject's own preferred brands of CC (no brand restriction) continue to be used as the reference product.

Timeline

• Start date: 2015-09-30
• Primary completion: 2017-03-13
• Completion: 2017-12-20
• First posted: 2016-01-07
• Last updated: 2020-12-04
• Results posted: 2020-12-04

Locations

19 sites across 1 country: United States