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 Products S.A.672 enrolled

Overview

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. 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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

672

Conditions

Smoking

Interventions

Eligibility

Sex: ALLMin age: 30 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (19)

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

...and 9 more locations

Outcomes

Primary Outcomes

Levels of High Density Lipoprotein C (HDL-C).

Concentrations (mg/dL) measured in serum. Mean values are provided as descriptive statistics.

Time frame: 52 weeks

Levels of White Blood Cells (WBC).

Total count in blood (GI/L). Mean values are provided as descriptive statistics.

Time frame: 52 weeks

Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1).

FEV1 post-bronchodilator and expressed as percentage predicted (FEV1 %pred). Mean values are provided as descriptive statistics.

Time frame: 52 weeks

Concentrations of Soluble Intercellular Adhesion Molecule 1 (sICAM-1).

Concentrations (ng/mL) measured in serum. Geometric Mean values are provided as descriptive statistics.

Time frame: 52 weeks

Concentrations of 11-dehydrothromboxane B2 (11-DTXB2).

Concentrations measured in urine and expressed as concentration adjusted for creatinine (pg/mg creat). Geometric Mean values are provided as descriptive statistics.

Time frame: 52 weeks

Concentrations of 8-epi-prostaglandin F2α (8-epi-PGF2α).

Concentrations measured in urine and expressed as concentration adjusted for creatinine (pg/mg creat). Geometric Mean values are provided as descriptive statistics.

Time frame: 52 weeks

Concentrations of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL).

Concentrations measured in urine and expressed as concentration adjusted for creatinine (pg/mg creat). Geometric Mean values are provided as descriptive statistics.

Time frame: 52 weeks

Levels of Carboxyhemoglobin (COHb).

Carboxyhemoglobin (COHb) is assayed from whole blood. Expressed as % of saturation of hemoglobin. Geometric Mean values are provided as descriptive statistics.

Time frame: 52 weeks