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

Completed

• Conditions: Healthy; Smoking

• Registration Number: NCT02103751
• Lead Sponsor: Philip Morris Products S.A.

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.

Study Timeline

• Study Start: 2007-07
• Primary Completion: 2007-12
• Study Completion: 2008-02
• Study First Submitted: 2014-03-20
• Study First Submitted QC: 2014-04-02
• Study First Posted: 2014-04-04
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-05
• Last Update Posted: 2019-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1069

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The level of biomarkers of Exposure (BoExp) to HPHCs - present in cigarette smoke - in Asian smokers compared to non smokers	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	At Visit 2 (up to14 days after Visit 1)

Trial Locations

Locations (1)

Bio-Iatric Centre, Research Institute for Clinical Pharmacology, Kitasato University; 🇯🇵 Tokyo, Japan