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



Status:Completed
Conditions:Smoking Cessation
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:30 - Any
Updated:1/14/2018
Start Date:September 30, 2015
End Date:December 20, 2017

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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

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.

The ZRHR-ERS-09-EXT-US study is a 26-week extension of the original study ZRHR-ERS-09-US.

This study will be 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 will be using the same sites.

Subjects will continue to use the product they were randomized to in the original study
ZRHR-ERS-09-US (THS 2.2 arm or CC arm).

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.
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2147 Northeast Coachman Road
Clearwater, Florida 33765
Phone: 727-466-0078
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100 West Gore St # 202
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Austin, Texas 78705
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Bristol, Tennessee 37620
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Cary, North Carolina 27518
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Charlotte, North Carolina 28209
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1 Elizabeth Place
Dayton, Ohio 45417
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San Angelo, Texas 76904
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5115 North Armenia Avenue
Tampa, Florida 33603
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Tempe, Arizona 85283
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The Villages, Florida 32162
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1907 Tradd Ct
Wilmington, North Carolina 28401
(910) 799-5500
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PMG Research of Wilmington PMG Research of Wilmington has two offices situated in a 1...
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