European Exposure Study

Smoking Clinical Trial

Official title:

A European, Multi-centre Study to Determine the Exposure of Adult Smokers and Non-smokers to Cigarette Smoke Constituents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01237912
• Other study ID #: SPA0403
• Status: Completed
• Start date: April 2005
• Est. completion date: December 2006

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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1667
• Est. completion date: December 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Smoking

Locations

Country	Name	City	State
United Kingdom	Stephen Smith	Belfast	Northern Ireland

Sponsors (1)

Lead Sponsor	Collaborator
Philip Morris Products S.A.

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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: 10.11 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the exposure of adult smokers and non-smokers to cigarette smoke constituents	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).	2 consecutive visits within 14 days