Reduced Exposure Study in Smokers Using THS 2.2 With 5 Days in a Confinement Setting.

• 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: Philip Morris Products S.A.
• Information provided by (Responsible Party): Philip Morris Products S.A.

Tracking Information

• First Submitted Date: October 8, 2013
• First Posted Date: October 10, 2013
• Results First Submitted Date: January 26, 2016
• Results First Posted Date: October 13, 2016
• Last Update Posted Date: March 12, 2020
• Study Start Date: June 2013
• Actual Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: October 9, 2013)

Measurement of BOExp to HPHCs: monohydroxybutenyl mercapturic acid (MHBMA); 3-hydroxypropylmercapturic acid (3-HPMA); S-phenylmercapturic acid (S-PMA) as concentration adjusted to creatinine in urine and carboxyhemoglobin (COHb) in blood as % [ Time Frame: Day 5 ]

Measurement of the reduction of exposure to HPHCs: respectively 1,3-butadiene; acrolein; benzene and carbon monoxide (HPHCs) after 5 days of switching from conventional cigarettes to THS 2.2 compared to values measured in subjects who continue smoking conventional cigarettes.

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Reduced Exposure Study in Smokers Using THS 2.2 With 5 Days in a Confinement Setting.
• 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.
• 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).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Other
• Condition: Smoking

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 19, 2014): 169
• Original Estimated Enrollment (submitted: October 9, 2013): 168
• Actual Study Completion Date: June 2014
• Actual Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Poland

Administrative Information

• NCT Number: NCT01959932
• Other Study ID Numbers: ZRHR-REXC-03-EU; ZRHR-REXC-03-EU ( Other Identifier: Philip Morris Products S.A. )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Philip Morris Products S.A.
• Original Responsible Party: Same as current
• Current Study Sponsor: Philip Morris Products S.A.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: Christelle Haziza, PhD; Philip Morris Products S.A.
• Principal Investigator: Katarzyna Jarus-Dziedzic, MD PhD; BioVirtus Research Site

• PRS Account: Philip Morris Products S.A.
• Verification Date: March 2020