At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A clinical study evaluating THS 2.2 and CC for Smoking. Completed, enrolled 672 participants across 19 sites.
Detailed 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.
Study Details
Timeline
Interventions
Ad libitum use of THS 2.2 in an ambulatory setting for 26 weeks.
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.