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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.

Tracking Information
First Submitted Date  ICMJE January 5, 2016
First Posted Date  ICMJE January 7, 2016
Last Update Posted Date January 12, 2018
Actual Study Start Date  ICMJE September 30, 2015
Actual Primary Completion Date March 13, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2017)
  • 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.
  • Levels of white blood cells (WBC). [ Time Frame: 52 weeks ]
    Concentrations measured in blood. Geometric Least Squares means are provided as descriptive statistics.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 6, 2016)
  • Changes in the levels of high density lipoprotein C (HDL-C) in smokers switching from CC to THS 2.2 as compared to smokers continuing to smoke CC. [ Time Frame: 52 weeks ]
    Concentrations measured in serum.
  • Changes in the levels of white blood cells (WBC) in smokers switching from CC to THS 2.2 as compared to smokers continuing to smoke CC. [ Time Frame: 52 weeks ]
    Concentrations measured in blood.
  • Changes in post-bronchodilator forced expiratory volume in 1 second (FEV1) in smokers switching from CC to THS 2.2 as compared to smokers continuing to smoke CC. [ Time Frame: 52 weeks ]
    FEV1 post-bronchodilator and expressed as percentage predicted (FEV1 %pred).
  • Changes in the concentrations of soluble intercellular adhesion molecule 1 (sICAM-1) in smokers switching from CC to THS 2.2 as compared to smokers continuing to smoke CC. [ Time Frame: 52 weeks ]
    Concentrations measured in serum.
  • Changes in the concentrations of 11-dehydrothromboxane B2 (11-DTXB2) in smokers switching from CC to THS 2.2 as compared to smokers continuing to smoke CC. [ Time Frame: 52 weeks ]
    Concentrations measured in urine and expressed as concentration adjusted for creatinine.
  • Changes in the concentrations of 8-epi-prostaglandin F2α (8-epi-PGF2α) in smokers switching from CC to THS 2.2 as compared to smokers continuing to smoke CC. [ Time Frame: 52 weeks ]
    Concentrations measured in urine and expressed as concentration adjusted for creatinine.
  • Changes in the concentrations of total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (total NNAL) in smokers switching from CC to THS 2.2 as compared to smokers continuing to smoke CC. [ Time Frame: 52 weeks ]
    Concentrations measured in urine and expressed as concentration adjusted for creatinine.
  • Changes in the levels of carboxyhemoglobin (COHb) in smokers switching from CC to THS 2.2 as compared to smokers continuing to smoke CC. [ Time Frame: 52 weeks ]
    Carboxyhemoglobin (COHb) is assayed from whole blood. Expressed as % of saturation of hemoglobin
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Smoking
Intervention  ICMJE
  • Other: THS 2.2
    Ad libitum use of THS 2.2 in an ambulatory setting for 26 weeks.
  • 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.

Study Arms  ICMJE
  • Experimental: THS 2.2
    Ad libitum use of THS 2.2
    Intervention: Other: THS 2.2
  • Active Comparator: CC
    Ad libitum use of CC
    Intervention: Other: CC
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 20, 2016)
672
Original Estimated Enrollment  ICMJE
 (submitted: January 6, 2016)
700
Actual Study Completion Date  ICMJE December 20, 2017
Actual Primary Completion Date March 13, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02649556
Other Study ID Numbers  ICMJE ZRHR-ERS-09-EXT-US
ZRHR-ERS-09-EXT-US ( Other Identifier: Philip Morris Products S.A. )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Philip Morris Products S.A.
Study Sponsor  ICMJE Philip Morris Products S.A.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Philip Morris Products S.A.
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP