Clinical Studies

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

First posted
Jan 7, 2016
Identifier
NCT02649556
Publication Site URL
Topic
Official Title

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

Brief 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.

Summary

Recruitment: Completed

Study Results: Available

Enrollment: 672

Study Type: Interventional

Other IDs: ZRHR-ERS-09-EXT-US

Related Publications

Evaluating Use Patterns of a Closed Electronic Nicotine Delivery System Among Adults in the United States Who Smoke Cigarettes Daily: 8-Week Actual Use Study

Perception and Behavior

Barriers to stop smoking (BASS): Results and insights from four years of empirical research in Germany

Perception and Behavior

Unlocking a decade of tobacco heating system post-market surveillance

Post-Market Studies and Surveillance Study

Reasons for oral nicotine product use among adults who smoke or use smoke-free products in Germany - Results from the Barrier to Stopping smoking (BASS) survey

Perception and Behavior

Misunderstanding nicotine delivery: Discussion on nicotine pouches

Nicotine

AeroSolved: Wall Boundary Conditions for Liquid Multispecies Aerosol Deposition at Transient and High-Humidity Flows

Aerosol Physics

PMIScience.com is operated by Philip Morris International for the purpose of publishing and disseminating scientific information about Philip Morris International’s efforts in support of its smoke-free product portfolio. This site is a global site for use by scientists, the public health and regulatory communities, and other stakeholders with an interest in tobacco policy. The purpose of this site is not advertising or marketing, nor is it directed at any specific market. It is not intended for use by consumers. New tobacco products sold in the United States are subject to FDA regulation; therefore the content of this site is not intended to make, and nor should it be construed as making, any product related claims in the United States without proper FDA authorization. ​
​
Reduced Risk Products ("RRPs”) is the term we use to refer to products that present, are likely to present, or have the potential to present less risk of harm to smokers who switch to these products versus continuing smoking. PMI has a range of RRPs in various stages of development, scientific assessment and commercialization. All of our RRPs are smoke-free products that deliver nicotine with far lower quantities of harmful and potentially harmful constituents than found in cigarette smoke.