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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
Results First Posted : December 4, 2020
Last Update Posted : December 4, 2020
Sponsor:
Information provided by (Responsible Party):
Philip Morris Products S.A.

Study Description
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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.

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 Design
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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
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Levels of High Density Lipoprotein C (HDL-C). [ Time Frame: 52 weeks ]
    Concentrations (mg/dL) measured in serum. Mean values are provided as descriptive statistics.

  2. Levels of White Blood Cells (WBC). [ Time Frame: 52 weeks ]
    Total count in blood (GI/L). Mean values 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). Mean values are provided as descriptive statistics.

  4. Concentrations of Soluble Intercellular Adhesion Molecule 1 (sICAM-1). [ Time Frame: 52 weeks ]
    Concentrations (ng/mL) measured in serum. Geometric Mean values 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 (pg/mg creat). Geometric Mean values 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 (pg/mg creat). Geometric Mean values 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 (pg/mg creat). Geometric Mean values 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 Mean values are provided as descriptive statistics.


Eligibility Criteria
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Information from the National Library of Medicine

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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.
Contacts and Locations
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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
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Sponsors and Collaborators
Philip Morris Products S.A.
Investigators
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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
  Study Documents (Full-Text)

Documents provided by Philip Morris Products S.A.:
Study Protocol  [PDF] August 23, 2016
Statistical Analysis Plan  [PDF] December 8, 2017

More Information
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Responsible Party: Philip Morris Products S.A.
ClinicalTrials.gov Identifier: NCT02649556    
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
Results First Posted: December 4, 2020
Last Update Posted: December 4, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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.:
Modified risk tobacco product
Conventional cigarette
Exposure response
Smoking
Tobacco Heating System