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

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: NCT02396381
Recruitment Status : Completed
First Posted : March 24, 2015
Results First Posted : August 21, 2019
Last Update Posted : January 26, 2023
Sponsor:
Information provided by (Responsible Party):
Philip Morris Products S.A.

Study Description
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Brief Summary:

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.


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

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1039 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: 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
Actual Study Start Date : March 12, 2015
Actual Primary Completion Date : September 13, 2016
Actual Study Completion Date : August 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


  2. Levels of White Blood Cells (WBC). [ Time Frame: 26 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: 26 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: 26 Weeks ]

    Concentrations measured in serum.

    Geometric Least Squares means are provided as descriptive statistics.


  5. 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.


  6. 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.


  7. 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.


  8. 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.



Eligibility Criteria
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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.


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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:

  • 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.
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): NCT02396381


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: Lon Lynn, MD Clinical Research West Florida
Principal Investigator: David Subich, MD Compass Research
Principal Investigator: Isabel Kuhare-Arcure, MD Midwest Clinical Research
Principal Investigator: Keith Scott, MD National Clinical Research
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Philip Morris Products S.A.
ClinicalTrials.gov Identifier: NCT02396381    
Other Study ID Numbers: ZRHR-ERS-09-US
ZRHR-ERS-09-US ( Other Identifier: Philip Morris Products S.A. )
First Posted: March 24, 2015    Key Record Dates
Results First Posted: August 21, 2019
Last Update Posted: January 26, 2023
Last Verified: January 2023
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.:
Candidate modified risk tobacco product
Conventional cigarette
Exposure response
Smoking
Tobacco Heating System