Determination of Biomarkers of Exposure and Biomarkers of Potential Harm in Asian Adult Cigarette Smokers

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.

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Key information

Conditions

Smoking Behavior Healthy

Age range

30 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bio-Iatric Centre, Research Institute for Clinical Pharmacology, Kitasato University

Tokyo, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

The level of biomarkers of Exposure (BoExp) to HPHCs - present in cigarette smoke - in Asian smokers compared to non smokers

Time frame: At Visit 2 (up to14 days after Visit 1)

To measure the level of smoking, at baseline the Fagerstrom nicotine dependence test and urinary cotinine are measured. For measurement of biomarkers of exposure, blood and 24 hour urine sampling are performed at V2.
The level of CVD-related biomarkers in Asian smokers compared to non smokers

Time frame: At Visit 2 (up to14 days after Visit 1)

Sponsors and collaborators

Lead sponsor

Philip Morris Products S.A.

Industry

Registry information

Official study 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

Important dates

Study start: 2007
Primary completion: 2007
Study completion: 2008
First posted: Apr 4, 2014
Registry last updated: Nov 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed