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

Completed · Not applicable

Conditions studied: Smoking

In brief

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.

Key facts

Study ID

NCT02649556

Run by

Philip Morris Products S.A.

People needed

672

Starts

2015-09-30

Expected to finish

2017-12-20

Last updated by the study team

2020-12-04

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subject completed V10 of the original study (ZRHR-ERS-09-US).
• The subject is willing to comply to study procedures and to continue to use the product he/she was allocated to during the original study (THS 2.2 or CC) for an additional 26 weeks at V10.
• Subject has given written informed consent to enter the 26-week extension study at V10.

You may not qualify if…

• Clinically relevant medical conditions that in the opinion of the investigators would jeopardize the safety of the participant.
• As per judgment of the PI(s) or designee(s), the subject cannot participate in the study for any reason (e.g. medical, psychiatric and/or social reason).
• Subject has made an attempt to quit using tobacco-containing products (e.g. CC and THS 2.2) during the original study.
• Female subject is pregnant or breast feeding.
• Female subject who does not agree to use an acceptable method of effective contraception.

Where it is running

• Celerion Arizona — Tempe, Arizona, United States
• Clinical Research West Florida — Clearwater, Florida, United States
• Covance, Inc — Daytona Beach, Florida, United States
• Compass Research — Orlando, Florida, United States
• Clinical Research West Florida — Tampa, Florida, United States
• Compass Research — The Villages, Florida, United States
• Central Kentucky Research Associate — Lexington, Kentucky, United States
• Celerion Lincoln — Lincoln, Nebraska, United States
• PMG Research of Cary — Cary, North Carolina, United States
• PMG Research of Charlotte — Charlotte, North Carolina, United States
• PMG Research of Raleigh — Raleigh, North Carolina, United States
• PMG Research of Wilmington — Wilmington, North Carolina, United States
• Midwest Clinical Research — Dayton, Ohio, United States
• PMG Research of Bristol — Bristol, Tennessee, United States
• NOCCR — Knoxville, Tennessee, United States
• Benchmark — Austin, Texas, United States
• Benchmark — Fort Worth, Texas, United States
• Benchmark — San Angelo, Texas, United States
• National Clinical Research — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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