Evaluation of Biological and Functional Changes in Healthy Smokers After Switching to THS 2.2 for 26 Weeks

January 25, 2023 updated by: Philip Morris Products S.A.

A Randomized, Controlled, 2-arm Parallel Group, Multi-center Study, to Evaluate Biological and Functional Changes in Healthy Smokers Switching to Tobacco Heating System 2.2 (THS 2.2) Compared to Continuing Smoking Conventional Cigarettes for 26 Weeks in an Ambulatory Setting

The aim of the study is to demonstrate clinical, biological and functional health changes in smokers switching to the candidate modified risk tobacco product: Tobacco Heating System 2.2 (THS 2.2) as compared to smokers continuing smoking their conventional cigarettes (CC) over a 26-week period.

To characterize the study as successful, at least 5 clinical risk endpoints should move in the direction of smoking cessation and these results would be statistically significant. The main analysis will be defined a priori (using the Hailperin-Ruger approach) and will be made between THS 2.2 use and CC use as "per actual product used" and product use categories.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The clinical, biological and functional endpoints to be measured in this study ("smoker's health profile") may characterize the modification of risk of smoking-related diseases.

Clinical risk endpoint to be assessed are selected based on a) their association to smoking-related diseases b) their association to smoking status, c) their reversibility upon smoking cessation, and d) their suitability to be measured with valid and robust methods in clinical studies.

The biological markers, functional markers and biomarkers of exposure (BoExp) with the strongest scientific evidence will constitute the 'smoker's health profile' and will be measured as the primary objective of the study.

Additional endpoints involved in the mechanistic of smoking-related diseases will be studied to provide additional scientific evidence to strengthen the primary objective.

The study will provide a perspective of product usage in a "real world setting" where smoking CC in addition to THS 2.2 may be expected.

Study Type

Interventional

Enrollment (Actual)

1039

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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 Center
    • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Current healthy smoker as judged by the Principal Investigator(s) or designee(s)
  • Minimum age: 30 years old
  • Have smoked for the last 10 years
  • Have smoked more than 10 non menthol CC/day on average (no brand restriction) over the past year

Exclusion Criteria:

  • Clinically relevant medical conditions that in the opinion of the investigators would jeopardize the safety of the participant.
  • Subject who has (FEV1/FVC) < 0.7 and FEV1 < 80% predicted value at post-bronchodilator spirometry
  • Subject with asthma condition (post-bronchodilator FEV1/FVC < 0.75 and reversibility in FEV1 ≥ 12% and > 200 mL from pre- to post-bronchodilator values)
  • Subject who took or is taking concomitant medication which may have an impact on the "smoker's heath profile"
  • Female subject is pregnant or breast feeding.
  • Female subject who does not agree to use an acceptable method of effective contraception.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Levels of High Density Lipoprotein C (HDL-C).
Time Frame: 26 Weeks

Concentrations measured in serum.

Geometric Least Squares means are provided as descriptive statistics.
26 Weeks
Levels of White Blood Cells (WBC).
Time Frame: 26 Weeks

Concentrations measured in blood.

Geometric Least Squares means are provided as descriptive statistics.
26 Weeks
Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1).
Time Frame: 26 Weeks

FEV1 post-bronchodilator and expressed as percentage predicted (FEV1 %pred).

Geometric Least Squares means are provided as descriptive statistics.
26 Weeks
Concentrations of Soluble Intercellular Adhesion Molecule 1 (sICAM-1).
Time Frame: 26 Weeks

Concentrations measured in serum.

Geometric Least Squares means are provided as descriptive statistics.
26 Weeks
Concentrations of 11-dehydrothromboxane B2 (11-DTXB2).
Time Frame: 26 Weeks

Concentrations measured in urine and expressed as concentration adjusted for creatinine.

Geometric Least Squares means are provided as descriptive statistics.
26 Weeks
Concentrations of 8-epi-prostaglandin F2α (8-epi-PGF2α).
Time Frame: 26 Weeks

Concentrations measured in urine and expressed as concentration adjusted for creatinine.

Geometric Least Squares means are provided as descriptive statistics.
26 Weeks
Concentrations of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL).
Time Frame: 26 Weeks

Concentrations measured in urine and expressed as concentration adjusted for creatinine.

Geometric Least Squares means are provided as descriptive statistics.
26 Weeks
Percent Change From Baseline of Carboxyhemoglobin (COHb)
Time Frame: 26 Weeks

Carboxyhemoglobin (COHb) is assayed from whole blood.

Geometric Least Squares means are provided as descriptive statistics. Expressed as % of saturation of hemoglobin.
26 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Philip Morris Products S.A.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2015

Primary Completion (Actual)

September 13, 2016

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

March 18, 2015

First Submitted That Met QC Criteria

March 18, 2015

First Posted (Estimate)

March 24, 2015

Study Record Updates

Last Update Posted (Actual)

January 26, 2023

Last Update Submitted That Met QC Criteria

January 25, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ZRHR-ERS-09-US (Other Identifier: 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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