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

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.

Study Overview

• Status: Completed
• Conditions: Smoking
• Intervention / Treatment: Other: THS 2.2; Other: CC

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 Type: Interventional
• Enrollment (Actual): 672
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tempe, Arizona, United States, 85283
      • Celerion Arizona
  • Florida
    • Clearwater, Florida, United States, 33765
      • Clinical Research West Florida
    • Daytona Beach, Florida, United States, 32117
      • Covance, Inc
    • Orlando, Florida, United States, 32806
      • Compass Research
    • Tampa, Florida, United States, 33603
      • Clinical Research West Florida
    • The Villages, Florida, United States, 32162
      • Compass Research
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • Central Kentucky Research Associate
  • Nebraska
    • Lincoln, Nebraska, United States, 68502
      • Celerion Lincoln
  • North Carolina
    • Cary, North Carolina, United States, 27518
      • PMG Research of Cary
    • Charlotte, North Carolina, United States, 28209
      • PMG Research of Charlotte
    • Raleigh, North Carolina, United States, 27609
      • PMG Research of Raleigh
    • Wilmington, North Carolina, United States, 28401
      • PMG Research of Wilmington
  • Ohio
    • Dayton, Ohio, United States, 45417
      • Midwest Clinical Research
  • Tennessee
    • Bristol, Tennessee, United States, 37620
      • PMG Research of Bristol
    • Knoxville, Tennessee, United States, 37920
      • NOCCR
  • Texas
    • Austin, Texas, United States, 78705
      • BenchMark
    • Fort Worth, Texas, United States, 76135
      • BenchMark
    • San Angelo, Texas, United States, 76904
      • BenchMark
  • Virginia
    • Richmond, Virginia, United States, 23294
      • National Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: THS 2.2; Ad libitum use of THS 2.2	Other: THS 2.2; Ad libitum use of THS 2.2 in an ambulatory setting for 26 weeks.
ACTIVE_COMPARATOR: CC; Ad libitum use of CC	Other: CC; Ad libitum use of CC in an ambulatory setting for 26 weeks. The subject's own preferred brands of CC (no brand restriction) continue to be used as the reference product.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Levels of High Density Lipoprotein C (HDL-C).	Concentrations (mg/dL) measured in serum. Mean values are provided as descriptive statistics.	52 weeks
Levels of White Blood Cells (WBC).	Total count in blood (GI/L). Mean values are provided as descriptive statistics.	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.	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.	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.	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.	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.	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.	52 weeks

Collaborators and Investigators

• Sponsor: Philip Morris Products S.A.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 30, 2015
• Primary Completion (ACTUAL): March 13, 2017
• Study Completion (ACTUAL): December 20, 2017

Study Registration Dates

• First Submitted: January 5, 2016
• First Submitted That Met QC Criteria: January 6, 2016
• First Posted (ESTIMATE): January 7, 2016

Study Record Updates

• Last Update Posted (ACTUAL): December 4, 2020
• Last Update Submitted That Met QC Criteria: November 10, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Smoking; Modified risk tobacco product; Tobacco Heating System; Conventional cigarette; Exposure response
• Other Study ID Numbers: ZRHR-ERS-09-EXT-US (OTHER: Philip Morris Products S.A.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No