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European Exposure Study

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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.

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.

Condition or disease
Smoking

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.

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Study Type : Observational
Actual Enrollment : 1667 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: A European, Multi-centre Study to Determine the Exposure of Adult Smokers and Non-smokers to Cigarette Smoke Constituents
Study Start Date : April 2005
Actual Primary Completion Date : May 2006
Actual Study Completion Date : December 2006



Primary Outcome Measures :
  1. 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).


Biospecimen Retention:   Samples Without DNA
Urine


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

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): NCT01237912


Locations
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United Kingdom
Stephen Smith
Belfast, Northern Ireland, United Kingdom, BT96AD
Sponsors and Collaborators
Philip Morris Products S.A.
Investigators
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Principal Investigator: Stephen Smith Celerion, 22-24 Lisburn Road, Belfast, BT9 6AD, Northern Ireland
Publications of Results:
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Responsible Party: Philip Morris Products S.A.
ClinicalTrials.gov Identifier: NCT01237912    
Other Study ID Numbers: SPA0403
First Posted: November 10, 2010    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: November 2019