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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02103751
• Other study ID #: CS06-01
• Status: Completed
• Start date: July 2007
• Est. completion date: February 2008

Study information

• Verified date: November 2019
• Source: Philip Morris Products S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1069
• Est. completion date: February 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Smoking

Locations

Country	Name	City	State
Japan	Bio-Iatric Centre, Research Institute for Clinical Pharmacology, Kitasato University	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Philip Morris Products S.A.

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Lüdicke 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The level of biomarkers of Exposure (BoExp) to HPHCs - present in cigarette smoke - in Asian smokers compared to non smokers	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.	At Visit 2 (up to14 days after Visit 1)
Primary	The level of CVD-related biomarkers in Asian smokers compared to non smokers		At Visit 2 (up to14 days after Visit 1)