Clinical trial NCT02103751: Determination of Biomarkers of Exposure and Biomarkers of Potential Harm in Asian Adult Cigarette Smokers
Official title: A Multi-center Study to Determine the Levels of Biomarkers of Potential Harm and Biomarkers of Exposure to Cigarette Smoke in Asian Adult Smokers and Non-smokers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Smoking
Healthy
Keywords: biomarkers
HPHCs
CVD
smoking
Smokers
non-smokers
Lead sponsor: Philip Morris Products S.A.
Sponsor class: INDUSTRY
First posted: 2014-04-04
Enrollment: 1069
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy male and female Japanese smokers and non smokers, 30 years of age or older.

Brief summary: The purpose of this study is to determine biomarkers of exposure to Harmful and Potentially Harmful Constituents (HPHCs) in Cigarette Smoke and cardiovascular-related biomarkers in smokers and non smokers.

Detailed description: Since Japanese mortality associated with cardiovascular disease (CVD) is lower than that in the USA although Japan is one of the top four tobacco consuming countries, this study aims to determine biomarkers of both level of exposure and CVD-related biological effects in Japanese smokers compared to non-smokers.

Biomarkers of Exposure (BoExp) include 2-naphthylamine (2-NA), 4-aminobiphenyl (4-ABP), 4-(methylnitrosaminoi)-1-(3-pyridil)-1-butanone (NNK), carbon monoxide (CO), nicotine, pyrene and 0-toluidine (o-TOL). CVD-related biomarkers include white blood cell (WBC) count, high sensitivity C-reactive protein (hs-CRP) and homocysteine in plasma; complemented with urinary 8-epi-prostaglandin F2α (8-epi-PGF2α), plasma malondialdehyde (MDA), urinary 11-DTXB2, plasma fibrinogen, high-density lipoprotein-cholesterol, triglycerides, sICAM-1, sVCAM-1 and von Willebrand Factor.

Eligibility criteria: Inclusion Criteria:

* Smokers have smoked commercially available conventional cigarettes (CC)
* With a minimum consumption of 10 CC per day for the last 5 years

Exclusion Criteria:

* Any prior medical condition or chronic disease
* Recent infection
* History of cancer
* Use of concomitant medication
* History of alcohol abuse
* Pregnant women

Primary outcomes:
measure: The level of biomarkers of Exposure (BoExp) to HPHCs - present in cigarette smoke - in Asian smokers compared to non smokers
timeFrame: At Visit 2 (up to14 days after Visit 1)
measure: The level of CVD-related biomarkers in Asian smokers compared to non smokers
timeFrame: At Visit 2 (up to14 days after Visit 1)
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Bio-Iatric Centre, Research Institute for Clinical Pharmacology, Kitasato University
Study officials:
affiliation: Kitasato University, Tokyo, Japan
name: Prof. Tomoko Hasunuma, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ludicke F, Magnette J, Baker G, Weitkunat R. A Japanese cross-sectional multicentre study of biomarkers associated with cardiovascular disease in smokers and non-smokers. Biomarkers. 2015;20(6-7):411-21. doi: 10.3109/1354750X.2015.1096303.