Status:

COMPLETED

European Exposure Study

Lead Sponsor:

Philip Morris Products S.A.

Conditions:

Smoking

Eligibility:

All Genders

21-85 years

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 o...

Eligibility Criteria

Inclusion

  • 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

  • Female subjects with child-bearing potential were to be excluded if
  • Subject was pregnant (or did not have negative pregnancy tests) or breast-feeding
  • Subject did not agree to use an acceptable method of contraception

Key Trial Info

Start Date :

April 1 2005

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

December 1 2006

Estimated Enrollment :

1667 Patients enrolled

Trial Details

Trial ID

NCT01237912

Start Date

April 1 2005

End Date

December 1 2006

Last Update

November 7 2019

Active Locations (1)

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1

Stephen Smith

Belfast, Northern Ireland, United Kingdom, BT96AD