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Reduced Exposure Study Using THS 2.2 Menthol With 5 Days in a Confinement Setting and 85 Days in an Ambulatory Setting

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ClinicalTrials.gov Identifier: NCT01970995
Recruitment Status : Completed
First Posted : October 28, 2013
Results First Posted : February 7, 2017
Last Update Posted : March 23, 2020
Sponsor:
Information provided by (Responsible Party):
Philip Morris Products S.A.

Study Description
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Brief Summary:
The main goal of the study is to evaluate if the ad libitum use of the THS 2.2 Menthol (mTHS 2.2) for 5 days in confinement and after 85 days of product use in an ambulatory setting, by Japanese adult healthy smokers results in a reduction in the levels of biomarkers of exposure for selected harmful and potentially harmful smoke constituents (HPHCs) compared to smokers continuing smoking their own preferred brand of menthol conventional cigarette (mCC) and smoking abstinence (SA). Smokers who remained abstinent from SA were used as a benchmark to provide context to the exposure reduction.

Condition or disease Intervention/treatment Phase
Smoking Other: THS 2.2 Menthol (mTHS 2.2) Other: Smoking Abstinence (SA) Other: Menthol Conventional Cigarette (mCC) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Randomized, Controlled, Multi-center Study to Demonstrate Reductions in Exposure to Selected Smoke Constituents in Smokers Switching to THS 2.2 Menthol or Smoking Abstinence Compared to Smoking Menthol Conventional Cigarettes, for 90 Days
Study Start Date : August 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking
Drug Information available for: Menthol

Arms and Interventions
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Arm Intervention/treatment
Experimental: THS 2.2 Menthol (mTHS 2.2)
Ad libitum use of THS 2.2 Menthol for 5 Days in a Confinement Setting and 85 Days in an Ambulatory Setting
 Other: THS 2.2 Menthol (mTHS 2.2)
THS 2.2 Menthol ad libitum for 5 days in confinement prolonged by 85 days in an ambulatory setting
Active Comparator: Smoking abstinence (SA)
Abstinence from smoking for 5 Days in a Confinement Setting and 85 Days in an Ambulatory Setting
 Other: Smoking Abstinence (SA)
SA for 5 days in confinement prolonged by 85 days in an ambulatory setting
Active Comparator: Menthol Conventional Cigarette (mCC)
Ad libitum use of subject's own preferred brand of mCC for 5 Days in a Confinement Setting and 85 Days in an Ambulatory Setting
 Other: Menthol Conventional Cigarette (mCC)
Subject's own preferred brand of mCC ad libitum for 5 days in confinement prolonged by 85 days in an ambulatory setting


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 (LS) 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 (LS) 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.


  5. Concentration 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 are provided as descriptive statistics.



Eligibility Criteria
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Ages Eligible for Study:   23 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject is Japanese.
  • Smoking, healthy subject as judged by the Investigator.
  • Subject smokes at least 10 commercially available mCCs per day (no brand restrictions) for the last 4 weeks, based on self-reporting.
  • 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).
  • The 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 1 A2 (CYP1A2) or cytochrome P450 2 A6 (CYP2A6) activity.
  • For women: Subject is pregnant or is breast feeding.
  • For women: 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): NCT01970995


Locations
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Japan
Osaki Hospital Tokyo Heart Center, 5-4-12, Kitashinagawa, Shinagawa-ku
Tokyo, Japan
Sponsors and Collaborators
Philip Morris Products S.A.
Investigators
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Principal Investigator: Masahiro Endo, MD Osaki Hospital Tokyo Heart Center
Study Chair: Christelle Haziza, PhD Philip Morris Products S.A.
  Study Documents (Full-Text)

Documents provided by Philip Morris Products S.A.:
Study Protocol  [PDF] April 7, 2014
Statistical Analysis Plan  [PDF] November 7, 2014

More Information
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Responsible Party: Philip Morris Products S.A.
ClinicalTrials.gov Identifier: NCT01970995    
Other Study ID Numbers: ZRHM-REXA-07-JP
ZRHM-REXA-07-JP ( Other Identifier: Philip Morris Products S.A. )
First Posted: October 28, 2013    Key Record Dates
Results First Posted: February 7, 2017
Last Update Posted: March 23, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Philip Morris Products S.A.:
Candidate modified risk tobacco product
Conventional cigarettes
Reduced exposure
HPHCs
Ambulatory
Additional relevant MeSH terms:
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Menthol
Antipruritics
Dermatologic Agents