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Reduced Exposure Study Using the CHTP 1.2 With 5 Days in a Confinement Setting Followed by 85 Days in an Ambulatory Setting.

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: NCT02641587
Recruitment Status : Completed
First Posted : December 29, 2015
Results First Posted : March 6, 2019
Last Update Posted : March 27, 2020
Sponsor:
Information provided by (Responsible Party):
Philip Morris Products S.A.

Brief Summary:
The overall goal of the study is to demonstrate reduction in the levels of biomarkers of exposure (BoExp) to selected harmful and potentially harmful constituents (HPHCs) identified in cigarettes and to obtain safety information in healthy adult smokers switching to the Carbon Heated Tobacco Product 1.2 (CHTP 1.2) as compared to subjects continuing smoking cigarettes (CC) in a confinement setting for 5 days (exclusive use) followed by an ambulatory setting of 85 days.

Condition or disease Intervention/treatment Phase
Smoking Other: CHTP 1.2 Other: CC Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Randomized, Controlled, Open-label, 2-arm Parallel Group, Single Center Study to Demonstrate Reductions in Exposure to Selected Smoke Constituents in Healthy Smokers Switching to the Carbon Heated Tobacco Product 1.2 (CHTP 1.2), Compared to Continuing to Use Combustible Cigarettes, for 5 Days in Confinement Followed by 85 Days in an Ambulatory Setting.
Actual Study Start Date : January 2016
Actual Primary Completion Date : August 2016
Actual Study Completion Date : July 2017

Arm Intervention/treatment
Experimental: CHTP 1.2
Ad libitum use of the CHTP 1.2
Other: CHTP 1.2
Ad libitum use of the CHTP 1.2 for 5 days in confinement followed by 85 days in an ambulatory setting.

Active Comparator: CC
Ad libitum use of subject's own preferred non-menthol brand of CC
Other: CC
Ad libitum use of subject's own preferred non-menthol brand of CC for 5 days in confinement followed by 85 days in an ambulatory setting.




Primary Outcome Measures :
  1. Concentrations of Monohydroxybutenylmercapturic Acid (MHBMA) [ Time Frame: 5 days ]

    Concentrations measured at Day 5 in urine, adjusted for creatinine.

    Geometric least squares (LS) means and confidence intervals (Cls) from a generalized linear model conducted on log-transformed Day 5 values with log-transformed baseline value, study arm, sex and CC consumption reported at admission as fixed effect factors.


  2. Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA) [ Time Frame: 5 days ]

    Concentrations measured at Day 5 in urine, adjusted for creatinine.

    Geometric least squares (LS) means and confidence intervals (Cls) from a generalized linear model conducted on log-transformed Day 5 values with log-transformed baseline value, study arm, sex and CC consumption reported at admission as fixed effect factors.


  3. Concentration of S-phenylmercapturic Acid (S-PMA) [ Time Frame: 5 days ]

    Concentrations measured at Day 5 in urine, adjusted for creatinine.

    Geometric least squares (LS) means and confidence intervals (Cls) from a generalized linear model conducted on log-transformed Day 5 values with log-transformed baseline value, study arm, sex and CC consumption reported at admission as fixed effect factors.


  4. Levels of Carboxyhemoglobin (COHb) [ Time Frame: 5 days ]

    % COHb blood measurements performed in the evening of Day 5, expressed as % of saturation of hemoglobin.

    Geometric least squares (LS) means and confidence intervals (Cls) from a generalized linear model conducted on log-transformed Day 5 values with log-transformed baseline value, study arm, sex and CC consumption reported at admission as fixed effect factors.


  5. Concentrations of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL) [ Time Frame: 90 days ]

    Concentrations measured at Day 90 in urine, adjusted for creatinine.

    Geometric least squares (LS) means and confidence intervals (Cls) from a generalized linear model conducted on log-transformed Day 90 values with log-transformed baseline value, study arm, sex and CC consumption reported at admission as fixed effect factors.




Information from the National Library of Medicine

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Ages Eligible for Study:   28 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject is aged ≥ 28 years.
  • Subject is Caucasian.
  • Subject is healthy, as judged by the Investigator.
  • Subject has smoked at least 10 commercially available non-menthol CCs per day (no brand restrictions) at least for the last 6 weeks prior to the screening visit and admission.
  • Subject has smoked at least for the last 10 years.
  • Subject does not plan to quit smoking in the next 6 months.

Exclusion Criteria:

  • As per Investigator judgment, the subject cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason).
  • Subject has received medication within 14 days or within 5 half-lives of the medication (whichever is longer), which has an impact on cytochrome P450 1A2 (CYP1A2) or cytochrome P450 2A6 (CYP2A6) activity.
  • Female subject is pregnant or breast feeding.
  • Female subject 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): NCT02641587


Locations
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Poland
BioVirtus Research Site Sp. z o.o.
Nadarzyn, Poland, 05-830
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: Monika Tomaszewska-Kiecana, MD BioVirtus Research Site
  Study Documents (Full-Text)

Documents provided by Philip Morris Products S.A.:
Study Protocol  [PDF] December 5, 2016
Statistical Analysis Plan  [PDF] January 27, 2017

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Responsible Party: Philip Morris Products S.A.
ClinicalTrials.gov Identifier: NCT02641587    
Other Study ID Numbers: P2R-REXA-07-EU
First Posted: December 29, 2015    Key Record Dates
Results First Posted: March 6, 2019
Last Update Posted: March 27, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Philip Morris Products S.A.:
Smoking
Cigarettes
Reduced exposure
Confinement
Ambulatory
Carbon Heated Tobacco Product