ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02649556
Recruitment Status : Completed
First Posted : January 7, 2016
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Smoking Other: THS 2.2 Other: CC Not Applicable

Detailed Description:

The ZRHR-ERS-09-EXT-US study is a 26-week extension of the original study ZRHR-ERS-09-US.

This study will be 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 will be using the same sites.

Subjects will continue 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  (Clinical Trial)
Actual Enrollment : 672 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: 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
Actual Study Start Date : September 30, 2015
Actual Primary Completion Date : March 13, 2017
Actual Study Completion Date : December 20, 2017

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.





Primary Outcome Measures :
  1. Levels of high density lipoprotein C (HDL-C). [ Time Frame: 52 weeks ]

    Concentrations measured in serum.

    Geometric Least Squares means are provided as descriptive statistics.


  2. Levels of white blood cells (WBC). [ Time Frame: 52 weeks ]

    Concentrations measured in blood.

    Geometric Least Squares means are provided as descriptive statistics.


  3. Post-bronchodilator forced expiratory volume in 1 second (FEV1). [ Time Frame: 52 weeks ]

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

    Geometric Least Squares means are provided as descriptive statistics.


  4. Concentrations of soluble intercellular adhesion molecule 1 (sICAM-1). [ Time Frame: 52 weeks ]

    Concentrations measured in serum.

    Geometric Least Squares means are provided as descriptive statistics.


  5. Concentrations of 11-dehydrothromboxane B2 (11-DTXB2). [ Time Frame: 52 weeks ]

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

    Geometric Least Squares means are provided as descriptive statistics.


  6. Concentrations of 8-epi-prostaglandin F2α (8-epi-PGF2α). [ Time Frame: 52 weeks ]

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

    Geometric Least Squares means are provided as descriptive statistics.


  7. Concentrations of total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (total NNAL). [ Time Frame: 52 weeks ]

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

    Geometric Least Squares means are provided as descriptive statistics.


  8. Levels of carboxyhemoglobin (COHb). [ Time Frame: 52 weeks ]

    Carboxyhemoglobin (COHb) is assayed from whole blood. Expressed as % of saturation of hemoglobin.

    Geometric Least Squares means are provided as descriptive statistics.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02649556


Locations
United States, Arizona
Celerion Arizona
Tempe, Arizona, United States, 85283
United States, Florida
Clinical Research West Florida
Clearwater, Florida, United States, 33765
Covance, Inc
Daytona Beach, Florida, United States, 32117
Compass Research
Orlando, Florida, United States, 32806
Clinical Research West Florida
Tampa, Florida, United States, 33603
Compass Research
The Villages, Florida, United States, 32162
United States, Kentucky
Central Kentucky Research Associate
Lexington, Kentucky, United States, 40509
United States, Nebraska
Celerion Lincoln
Lincoln, Nebraska, United States, 68502
United States, North Carolina
PMG Research of Cary
Cary, North Carolina, United States, 27518
PMG Research of Charlotte
Charlotte, North Carolina, United States, 28209
PMG Research of Raleigh
Raleigh, North Carolina, United States, 27609
PMG Research of Wilmington
Wilmington, North Carolina, United States, 28401
United States, Ohio
Midwest Clinical Research
Dayton, Ohio, United States, 45417
United States, Tennessee
PMG Research of Bristol
Bristol, Tennessee, United States, 37620
NOCCR
Knoxville, Tennessee, United States, 37920
United States, Texas
Benchmark
Austin, Texas, United States, 78705
Benchmark
Fort Worth, Texas, United States, 76135
Benchmark
San Angelo, Texas, United States, 76904
United States, Virginia
National Clinical Research
Richmond, Virginia, United States, 23294
Sponsors and Collaborators
Philip Morris Products S.A.
Investigators
Study Chair: Christelle Haziza, PhD Philip Morris Products S.A.
Principal Investigator: Danielle Armas, MD Celerion Arizona
Principal Investigator: Leonard Dunn, MD Clinical Research West Florida
Principal Investigator: Hugh Coleman, MD Covance
Principal Investigator: George Stoica, MD Compass Research
Principal Investigator: Mark Adams, MD Central Kentucky Research Associate
Principal Investigator: Peter Davidson, MD Celerion Lincoln
Principal Investigator: John Rubino, MD PMG Research of Raleigh
Principal Investigator: George Raad, MD PMG Research of Charlotte
Principal Investigator: Kevin Cannon, MD PMG Research of Wilmington
Principal Investigator: Derek Schroder, MD PMG Research of Cary
Principal Investigator: Stephanie Powell, MD PMG Research of Bristol
Principal Investigator: William Smith, MD NOCCR
Principal Investigator: Darrell Herrington, MD Benchmark
Principal Investigator: Laurence Chu, MD Benchmark
Principal Investigator: William Seger, MD Benchmark
Principal Investigator: David Subich, MD Compass Research
Principal Investigator: Lon Lynn, MD Clinical Research West Florida
Principal Investigator: Isabel Kuhare-Arcure, MD Midwest Clinical Research
Principal Investigator: Keith Scott, MD National Clinical Research

Responsible Party: Philip Morris Products S.A.
ClinicalTrials.gov Identifier: NCT02649556     History of Changes
Other Study ID Numbers: ZRHR-ERS-09-EXT-US
ZRHR-ERS-09-EXT-US ( Other Identifier: Philip Morris Products S.A. )
First Posted: January 7, 2016    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Philip Morris Products S.A.:
Candidate modified risk tobacco product
Conventional cigarette
Exposure response
Smoking
Tobacco Heating System