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

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ClinicalTrials.gov Identifier: NCT02103751
Recruitment Status : Completed
First Posted : April 4, 2014
Last Update Posted : November 7, 2019
Sponsor:
Information provided by (Responsible Party):
Philip Morris Products S.A.

Study Description
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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.

Condition or disease
Smoking Healthy

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 Design
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Study Type : Observational
Actual Enrollment : 1069 participants
Observational Model: Case-Control
Time Perspective: Prospective
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 Start Date : July 2007
Actual Primary Completion Date : December 2007
Actual Study Completion Date : February 2008
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. The level of CVD-related biomarkers in Asian smokers compared to non smokers [ Time Frame: At Visit 2 (up to14 days after Visit 1) ]

Eligibility Criteria
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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Healthy male and female Japanese smokers and non smokers, 30 years of age or older.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02103751


Locations
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Japan
Bio-Iatric Centre, Research Institute for Clinical Pharmacology, Kitasato University
Tokyo, Japan
Sponsors and Collaborators
Philip Morris Products S.A.
Investigators
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Principal Investigator: Prof. Tomoko Hasunuma, MD Kitasato University, Tokyo, Japan
More Information
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Publications of Results:

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Responsible Party: Philip Morris Products S.A.
ClinicalTrials.gov Identifier: NCT02103751    
Other Study ID Numbers: CS06-01
First Posted: April 4, 2014    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: November 2019
Keywords provided by Philip Morris Products S.A.:
biomarkers
HPHCs
CVD
 smoking
Smokers
non-smokers