Clinical trial NCT01970995: Reduced Exposure Study Using THS 2.2 Menthol With 5 Days in a Confinement Setting and 85 Days in an Ambulatory Setting
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Keywords: Candidate modified risk tobacco product
Conventional cigarettes
Reduced exposure
HPHCs
Ambulatory
Lead sponsor: Philip Morris Products S.A.
Sponsor class: INDUSTRY
First posted: 2013-10-28
Enrollment: 160
Sex: ALL
Minimum age (years): 23
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility 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.

Primary outcomes:
measure: Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA)
timeFrame: 5 days
measure: Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)
timeFrame: 5 days
measure: Concentration of S-phenylmercapturic Acid (S-PMA)
timeFrame: 5 days
measure: Levels of Carboxyhemoglobin (COHb)
timeFrame: 5 days
measure: Concentration of Total 4-(Methylnitrosamino)-1-(3- Pyridyl)-1-butanol) (Total NNAL)
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Osaki Hospital Tokyo Heart Center, 5-4-12, Kitashinagawa, Shinagawa-ku
Study officials:
affiliation: Osaki Hospital Tokyo Heart Center
name: Masahiro Endo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Philip Morris Products S.A.
name: Christelle Haziza, PhD
role: STUDY_CHAIR
References: