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

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ClinicalTrials.gov Identifier: NCT02396381
Recruitment Status : Completed
First Posted : March 24, 2015
Last Update Posted : November 21, 2017
Sponsor:
Information provided by (Responsible Party):
Philip Morris Products S.A.

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.

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 984 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 12, 2016
Actual Study Completion Date : August 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

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




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. Levels 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.




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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.

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
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 Center
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: 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Philip Morris Products S.A.
ClinicalTrials.gov Identifier: NCT02396381     History of Changes
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
Last Update Posted: November 21, 2017
Last Verified: November 2017
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