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Reduced Exposure Study in Smokers Using THS 2.2 With 5 Days in a Confinement 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: NCT01959932
Recruitment Status : Completed
First Posted : October 10, 2013
Results First Posted : October 13, 2016
Last Update Posted : March 12, 2020
Sponsor:
Information provided by (Responsible Party):
Philip Morris Products S.A.

Study Description
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Brief Summary:
The overall goal of the study is to evaluate if the ad libitum use of the Tobacco Heating System 2.2 (THS 2.2) for 5 days by adult healthy smokers results in a reduction in the levels of biomarkers of exposure (BoExp) for selected harmful and potentially harmful constituents (HPHCs) compared to smoking conventional cigarettes (CC) and smoking abstinence (SA).

Condition or disease Intervention/treatment Phase
Smoking Other: Tobacco Heating System (THS 2.2) Other: Smoking abstinence (SA) Other: Conventional cigarette (CC) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 169 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Randomized, Controlled, Open-label, 3-arm Parallel Group, Single-center Study to Demonstrate Reductions in Exposure to Selected Smoke Constituents in Smoking, Healthy Subjects Switching to the Tobacco Heating System 2.2 (THS 2.2) or Smoking Abstinence, Compared to Continuing to Use Conventional Cigarettes, for 5 Days in Confinement.
Study Start Date : June 2013
Actual Primary Completion Date : September 2013
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arms and Interventions
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Arm Intervention/treatment
Experimental: Tobacco Heating System (THS 2.2)
Ad libitum use of THS 2.2 for 5 days in confinement
 Other: Tobacco Heating System (THS 2.2)
THS 2.2 ad libitum for 5 days in confinement
Sham Comparator: Smoking abstinence (SA)
Abstinence from smoking for 5 days in confinement
 Other: Smoking abstinence (SA)
SA for 5 days in confinement
Active Comparator: Conventional cigarette (CC)
Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
 Other: Conventional cigarette (CC)
Subject's own preferred brand of CC ad libitum for 5 days in confinement


Outcome Measures
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Primary Outcome Measures :
  1. Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA) [ Time Frame: 5 days ]

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

    Geometric Least Squares (LS) means are provided as descriptive statistics.


  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 means are provided as descriptive statistics.


  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 means are provided as descriptive statistics.


  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 means are provided as descriptive statistics.



Eligibility Criteria
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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject is Caucasian.
  • Current healthy smoker as judged by the Principal Investigator.
  • Subject has smoked at least 10 commercially available non-menthol CCs per day (no brand restrictions) for the last 4 weeks.
  • Subject has smoked for at least the last 3 consecutive years.
  • Subject does not plan to quit smoking in the next 3 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.
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): NCT01959932


Locations
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Poland
BioVirtus Research Site Sp. z o.o.
Kajetany, 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: Katarzyna Jarus-Dziedzic, MD PhD BioVirtus Research Site
  Study Documents (Full-Text)

Documents provided by Philip Morris Products S.A.:
Study Protocol  [PDF] April 25, 2013
Statistical Analysis Plan  [PDF] May 27, 2014

More Information
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Responsible Party: Philip Morris Products S.A.
ClinicalTrials.gov Identifier: NCT01959932    
Other Study ID Numbers: ZRHR-REXC-03-EU
ZRHR-REXC-03-EU ( Other Identifier: Philip Morris Products S.A. )
First Posted: October 10, 2013    Key Record Dates
Results First Posted: October 13, 2016
Last Update Posted: March 12, 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
Candidate Modified Risk Tobacco Product
Conventional cigarettes
Reduced exposure
Confinement