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

Philip Morris

Status: Completed

Conditions: Smoking

Treatments: Other: CC; Other: THS 2.2

Study type: Interventional

Funder types: Industry

Identifiers

NCT02649556

ZRHR-ERS-09-EXT-US (Other Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 672 patients

Sex: All

Ages: 30+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

672 participants in 2 patient groups

THS 2.2

Experimental group

Description:

Ad libitum use of THS 2.2

Treatment:

Other: THS 2.2

CC

Active Comparator group

Description:

Ad libitum use of CC

Treatment:

Other: CC