Reduced Exposure Study in Smokers Using THS 2.2 With 5 Days in a Confinement Setting.
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ClinicalTrials.gov Identifier: NCT01959932 |
Recruitment Status :
Completed
First Posted : October 10, 2013
Results First Posted : October 13, 2016
Last Update Posted : March 12, 2020
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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 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 |
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 |
- 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.

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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 |
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.

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
Poland | |
BioVirtus Research Site Sp. z o.o. | |
Kajetany, Poland, 05-830 |
Study Chair: | Christelle Haziza, PhD | Philip Morris Products S.A. | |
Principal Investigator: | Katarzyna Jarus-Dziedzic, MD PhD | BioVirtus Research Site |
Documents provided by Philip Morris Products S.A.:
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 |
Smoking Candidate Modified Risk Tobacco Product Conventional cigarettes Reduced exposure Confinement |