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Reduced Exposure Study in Smokers Using the Tobacco Heating System 2.2 (THS 2.2) for 5 Days in a Confinement Setting

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ClinicalTrials.gov Identifier: NCT01970982
Recruitment Status : Completed
First Posted : October 28, 2013
Results First Posted : October 17, 2016
Last Update Posted : March 12, 2020
Sponsor:
Information provided by (Responsible Party):
Philip Morris Products S.A.

Tracking Information
First Submitted Date  ICMJE October 18, 2013
First Posted Date  ICMJE October 28, 2013
Results First Submitted Date  ICMJE January 26, 2016
Results First Posted Date  ICMJE October 17, 2016
Last Update Posted Date March 12, 2020
Study Start Date  ICMJE July 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 19, 2016)
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 26, 2013)
To demonstrate reduced levels of monohydroxybutenyl mercapturic acid (MHBMA); 3-hydroxypropylmercapturic acid (3-HPMA); S-phenylmercapturic acid (S-PMA) expressed as concentration adjusted to creatinine in urine and carboxyhemoglobin (COHb) in blood. [ Time Frame: 5 days ]
To demonstrate the reduction of exposure to respectively 1,3-butadiene; acrolein; benzene and carbon monoxide (HPHCs) after 5 days of switching from conventional cigarettes to THS 2.2 as compared to conventional cigarettes.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Reduced Exposure Study in Smokers Using the Tobacco Heating System 2.2 (THS 2.2) for 5 Days in a Confinement Setting
Official Title  ICMJE A Controlled, 3-arm Parallel Group Study to Demonstrate Reduction in Exposure to Smoke Constituents in Healthy Smokers Switching to THS 2.2 or to Smoking Abstinence, Compared to Conventional Cigarettes for 5 Days in Confinement
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 consecutive days by adult Japanese healthy smokers affects the levels of biomarkers of exposure for selected harmful and potentially harmful constituents (HPHCs) compared to smoking conventional cigarettes (CC) and smoking abstinence (SA).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Smoking
Intervention  ICMJE
  • Other: Tobacco Heating System (THS 2.2)
    THS 2.2 ad libitum for 5 days in confinement
  • Other: Smoking abstinence (SA)
    SA for 5 days in confinement
  • Other: Conventional cigarette (CC)
    Subject's own preferred brand of CC ad libitum for 5 days in confinement
Study Arms  ICMJE
  • Experimental: Tobacco Heating System (THS 2.2)
    Ad libitum use of THS 2.2 for 5 days in confinement
    Intervention: Other: Tobacco Heating System (THS 2.2)
  • Sham Comparator: Smoking abstinence (SA)
    Abstinence from smoking for 5 days in confinement
    Intervention: Other: Smoking abstinence (SA)
  • Active Comparator: Conventional cigarette (CC)
    Ad libitum use of Subject's own preferred brand of CC for 5 days in confinement
    Intervention: Other: Conventional cigarette (CC)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 19, 2014)
166
Original Estimated Enrollment  ICMJE
 (submitted: October 26, 2013)
320
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject is Japanese.
  • Smoking, healthy subject as judged by the Investigator.
  • Subject smokes at least 10 commercially available non-menthol CCs 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 CYP1A2 or 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 23 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01970982
Other Study ID Numbers  ICMJE ZRHR-REXC-04-JP
ZRHR-REXC-04-JP ( Other Identifier: Philip Morris Products S.A. )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Philip Morris Products S.A.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Philip Morris Products S.A.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Takuya Kunito, MD Higashi Shinjuku Clinic
Study Chair: Christelle Haziza, PhD Philip Morris Products S.A.
PRS Account Philip Morris Products S.A.
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP