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European Exposure Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01237912
Recruitment Status : Completed
First Posted : November 10, 2010
Last Update Posted : November 7, 2019
Sponsor:
Information provided by (Responsible Party):
Philip Morris Products S.A.

Tracking Information
First Submitted Date November 9, 2010
First Posted Date November 10, 2010
Last Update Posted Date November 7, 2019
Study Start Date April 2005
Actual Primary Completion Date May 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 5, 2019)
To determine the exposure of adult smokers and non-smokers to cigarette smoke constituents [ Time Frame: 2 consecutive visits within 14 days ]
To determine the exposure of adult smokers and non-smokers to the following cigarette smoke constituents: carbon monoxide, nicotine, acrolein, benzene, 1,3-butadiene, 4-aminobiphenyl (4-ABP), 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK), o-toluidine, pyrene (1-OHP), 2-aminonaphthalene (2-NA).
Original Primary Outcome Measures
 (submitted: November 9, 2010)
Differen To determine the exposure of adult smokers and non-smokers to cigarette smoke constituents [ Time Frame: 2 consecutive visits within 14 days ]
To determine the exposure of adult smokers and non-smokers to the following cigarette smoke constituents: carbon monoxide, nicotine, acrolein, benzene, 1,3-butadiene, 4-aminobiphenyl (4-ABP), 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK), o-toluidine, pyrene (1-OHP), 2-aminonaphthalene (2-NA).
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title European Exposure Study
Official Title A European, Multi-centre Study to Determine the Exposure of Adult Smokers and Non-smokers to Cigarette Smoke Constituents
Brief Summary The current study was designed to determine the exposure of adult smokers and non-smokers to cigarette smoke constituents through evaluation of selected biomarkers of exposure.
Detailed Description The purpose of the study was to provide a greater knowledge about human exposure to cigarette smoke constituents by evaluating selected biomarkers of exposure in smokers and non-smokers. This was an observational, parallel-group study to be conducted at multiple centres in the UK, Germany, and Switzerland. It was planned to enrol sufficient subjects such that at least 1440 subjects complete the study.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Urine
Sampling Method Non-Probability Sample
Study Population Male or female 21 years of age or older with a stable health status as determined by the Investigator and who were able to understand the subject information and to comply with the study procedures and study schedule.
Condition Smoking
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Lindner D, Smith S, Leroy CM, Tricker AR. Comparison of exposure to selected cigarette smoke constituents in adult smokers and nonsmokers in a European, multicenter, observational study. Cancer Epidemiol Biomarkers Prev. 2011 Jul;20(7):1524-36. doi: 10.1158/1055-9965.EPI-10-1186. Epub 2011 May 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 9, 2010)
1667
Original Actual Enrollment Same as current
Actual Study Completion Date December 2006
Actual Primary Completion Date May 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

Smokers: Subjects who smoked commercial cigarettes exclusively (less than or equal to 10 mg ISO tar yield in Germany and the UK; less than or equal to 12 mg ISO tar yield in Switzerland) with a regular consumption of at least 1 cigarette per day over the last 12 months without change in brand over the previous 3 months.

or

Non-smokers: Subjects who did not smoke commercial cigarettes, hand-rolled cigarettes, cigars, pipes, bidis, and did not use other nicotine-containing products (patch, gum, lozenges etc.) within 1 year prior to Visit 1 and throughout the study duration.

Exclusion Criteria:

  • Female subjects with child-bearing potential were to be excluded if

    1. Subject was pregnant (or did not have negative pregnancy tests) or breast-feeding
    2. Subject did not agree to use an acceptable method of contraception
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT01237912
Other Study ID Numbers SPA0403
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Philip Morris Products S.A.
Original Responsible Party John L. Magnette, PHILIP MORRIS PRODUCTS S.A., Quai Jeanrenaud 5, 2000 Neuchatel, Switzerland
Current Study Sponsor Philip Morris Products S.A.
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Stephen Smith Celerion, 22-24 Lisburn Road, Belfast, BT9 6AD, Northern Ireland
PRS Account Philip Morris Products S.A.
Verification Date November 2019