Investigate the Exposure to Selected Smoke Constituents in Smokers Switching to Distillation Based Smoking Article

Tracking Information
First Submitted Date ICMJE	December 19, 2008
First Posted Date ICMJE	December 22, 2008
Last Update Posted Date	March 6, 2009
Study Start Date ICMJE	November 2008
Actual Primary Completion Date	February 2009 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: December 19, 2008)	To demonstrate a reduction in the three primary biomarkers of exposure: Carboxyhaemoglobin concentration in blood, Urinary excretion of S-phenylmercapturic acid and urinary excretion of NNAL and NNAL-glucuronides (total NNAL) [ Time Frame: 5 days ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00812279 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: December 19, 2008)	To explore changes from baseline COHb, S-PMA, and total NNAL in the three study arms in the course of the study [ Time Frame: 5 days ]; To explore changes from baseline in the three study arms with regard to urinary excretion of biomarkers of exposure to several other smoke constituents. [ Time Frame: 5 days ]; To assess urinary excretion of nicotine and its five major nicotine metabolites in the three study arms [ Time Frame: 5 days ]; To assess nicotine and cotinine concentrations in plasma in the three study arms To compare levels of all biomarkers of exposure in the SMAR arm to those in the smoking cessation (SC) arm [ Time Frame: 5 days ]; To assess the mutagenicity potential in urine at the end of the study in the three study arms [ Time Frame: 5 days ]; To monitor blood pressure, pulse rate, electrocardiogram, clinical laboratory parameters (standard clinical biochemistry, standard haematology and urine analysis), and adverse events [ Time Frame: 5 days ]; To investigate craving and withdrawal symptoms as well as pulmonary symptoms in all three study arms by means of questionnaires [ Time Frame: 5 days ]; To investigate change in cytochrome P450 1A2 (CYP1A2) activity from D0 to D5 in the three study arms [ Time Frame: 5 days ]; To assess and compare human smoking topography (HST) in smokers before and after switching to SMAR [ Time Frame: 5 days ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Investigate the Exposure to Selected Smoke Constituents in Smokers Switching to Distillation Based Smoking Article
Official Title ICMJE	A Controlled, Randomised, Open-Label, 3-Arm Parallel Single-Centre Confinement Study to Investigate Exposure to Selected Smoke Constituents in Smokers Switching From Conventional Cigarettes to SMAR Cigarettes for 5 Days
Brief Summary	The overall purpose of this clinical study conducted in confinement under well-defined conditions is to obtain initial data on the levels of human body exposure to selected smoked constituents of the SMAR cigarette. The main objective of this study is to compare the biomarkers of exposure to cigarette smoke constituents in smokers switching to SMAR and to biomarkers in smokers of conventional cigarettes (CC). The biomarkers of exposure will be measured in blood and urine samples collected from the subjects. Moreover, the biomarkers in subjects smoking conventional or SMAR cigarettes will be compared with those biomarkers in smokers who stop smoking for 5 days. The short term safety of this new product will also be evaluated.
Detailed Description	This is a controlled, randomised, open-label, 3-arm parallel single centre confinement study to investigate exposure to selected smoke constituents in smokers switching from CC to SMAR for 5 days. 112 eligible subjects will be randomised to the 3 study arms: SMAR, conventional cigarettes (CC) and smoking cessation (SC) in a 2:1:1 ratio. Following the screening visit (within 4 weeks prior to the day of admission), the study will be run over an 8-day period in a confined environment, consisting of the admission day (D-2), a 2-day baseline period (D-1 and D0), and a 5-day exposure period (D1 to D5). Subjects will be discharged in the morning of D6. From the discharge of the subject, a 7-day safety follow-up period will be carried out (until D13).
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Basic Science
Condition ICMJE	Smoking
Intervention ICMJE	Other: Distillation based smoking article (SMAR cigarette) Subjects randomised to the SMAR arm will be trained by the site staff on the usage of SMAR and the corresponding lighter prior to smoking the first SMAR. Subjects will be allowed to smoke SMAR without any limit on consumption during the designated smoking times but have to request each SMAR from the site staff when they wish to smoke.; Other: conventional cigarette Subjects randomised to the CC arm will continue to smoke their preferred CC brand during the exposure period. Subjects will be allowed to smoke without any limit on consumption during the designated smoking times but will have to request each CC from the site staff when they wish to smoke.; Other: smoking cessation Subjects will not be allowed to smoke any cigarettes or to use any other nicotine/tobacco-containing products during the 5 days following randomisation.
Study Arms	Experimental: 1. SMAR Subjects will be allowed to smoke SMAR without any limit on consumption during the designated smoking times. Intervention: Other: Distillation based smoking article (SMAR cigarette); Active Comparator: 2 Conventional cigarette (CC) Subjects will be allowed to smoke without any limit on consumption during the designated smoking times. Intervention: Other: conventional cigarette; Active Comparator: 3. smoking cessation (SC) Subjects will not be allowed to smoke any cigarettes or to use any other nicotine/tobacco-containing products during the 5 days following randomisation. Intervention: Other: smoking cessation
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: December 19, 2008)	112
Original Estimated Enrollment ICMJE	Same as current
Actual Study Completion Date	February 2009
Actual Primary Completion Date	February 2009 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Caucasian adult smokers (male and female), with acceptable health conditions, aged from 23 to 55 years who usually smoke 10 to 30 non-mentholated conventional cigarettes (with a maximum ISO tar yield of 10 mg) per day, for at least the last 5 consecutive years, will be enrolled in this study. Exclusion Criteria: women of childbearing potential must be excluded if:Subject is pregnant (does not have negative pregnancy tests at screening and at D-2) or breastfeeding/ subject does not agree to use an acceptable method of effective contraception: intrauterine device, intrauterine system, established use of oral/injectable/implantable/ transdermal hormonal methods, barrier methods of contraception (condoms, occlusive caps) with spermicidal foam/gel/film/suppository, vasectomised partner or true abstinence (periodic abstinence and withdrawal are not effective methods) until the end of the safety follow-up period.
Sex/Gender	Sexes Eligible for Study: All
Ages	23 Years to 55 Years (Adult)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Poland
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00812279
Other Study ID Numbers ICMJE	YVD-CS01-EU
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	John L. Magnette - Head Clinical Assessment, Philip Morris Products SA
Study Sponsor ICMJE	Philip Morris Products S.A.
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Katarzyna Jarus-Dziedzic, MD MTZ Clinical Research Inc (Warsaw, Poland)
PRS Account	Philip Morris Products S.A.
Verification Date	March 2009
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP