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

Not Applicable

Completed

• Conditions: Smoking
• Interventions: Other: CC; Other: THS 2.2

• Registration Number: NCT02649556
• Lead Sponsor: Philip Morris Products S.A.

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.

Detailed 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).

Study Timeline

• Study Start: 2015-09-30
• Study First Submitted: 2016-01-05
• Study First Submitted QC: 2016-01-06
• Study First Posted: 2016-01-07
• Primary Completion: 2017-03-13
• Study Completion: 2017-12-20
• Results First Submitted: 2020-05-25
• Status Verified: 2020-11
• Results First Submitted QC: 2020-11-10
• Last Update Submitted: 2020-11-10
• Results First Posted: 2020-12-04
• Last Update Posted: 2020-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 672

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.

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CC	CC	Ad libitum use of CC
THS 2.2	THS 2.2	Ad libitum use of THS 2.2

Primary Outcome Measures

Name	Time	Method
Levels of Carboxyhemoglobin (COHb).	52 weeks	Carboxyhemoglobin (COHb) is assayed from whole blood. Expressed as % of saturation of hemoglobin. Geometric Mean values are provided as descriptive statistics.
Concentrations of 11-dehydrothromboxane B2 (11-DTXB2).	52 weeks	Concentrations measured in urine and expressed as concentration adjusted for creatinine (pg/mg creat). Geometric Mean values are provided as descriptive statistics.
Concentrations of Soluble Intercellular Adhesion Molecule 1 (sICAM-1).	52 weeks	Concentrations (ng/mL) measured in serum. Geometric Mean values are provided as descriptive statistics.
Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1).	52 weeks	FEV1 post-bronchodilator and expressed as percentage predicted (FEV1 %pred). Mean values are provided as descriptive statistics.
Levels of White Blood Cells (WBC).	52 weeks	Total count in blood (GI/L). Mean values are provided as descriptive statistics.
Concentrations of 8-epi-prostaglandin F2α (8-epi-PGF2α).	52 weeks	Concentrations measured in urine and expressed as concentration adjusted for creatinine (pg/mg creat). Geometric Mean values are provided as descriptive statistics.
Concentrations of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL).	52 weeks	Concentrations measured in urine and expressed as concentration adjusted for creatinine (pg/mg creat). Geometric Mean values are provided as descriptive statistics.
Levels of High Density Lipoprotein C (HDL-C).	52 weeks	Concentrations (mg/dL) measured in serum. Mean values are provided as descriptive statistics.

Trial Locations

Locations (15)

Celerion Arizona; 🇺🇸 Tempe, Arizona, United States

Celerion Lincoln; 🇺🇸 Lincoln, Nebraska, United States

Clinical Research West Florida; 🇺🇸 Tampa, Florida, United States

Covance, Inc; 🇺🇸 Daytona Beach, Florida, United States

Central Kentucky Research Associate; 🇺🇸 Lexington, Kentucky, United States

Compass Research; 🇺🇸 The Villages, Florida, United States

PMG Research of Cary; 🇺🇸 Cary, North Carolina, United States

PMG Research of Raleigh; 🇺🇸 Raleigh, North Carolina, United States

Midwest Clinical Research; 🇺🇸 Dayton, Ohio, United States

PMG Research of Charlotte; 🇺🇸 Charlotte, North Carolina, United States

PMG Research of Wilmington; 🇺🇸 Wilmington, North Carolina, United States

NOCCR; 🇺🇸 Knoxville, Tennessee, United States

Benchmark; 🇺🇸 San Angelo, Texas, United States

PMG Research of Bristol; 🇺🇸 Bristol, Tennessee, United States

National Clinical Research; 🇺🇸 Richmond, Virginia, United States