Expired Study
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Charlotte, North Carolina 28262


Purpose:

The purpose of this study is to understand the biological and functional changes after one year of smoking cessation and to collect data on a broad range of biomarkers of exposure (BoExp).


Study summary:

The BoExp to be measured are selected based on: 1. HPHCs derived from the list of HPHCs recommended for lowering in cigarette smoke by the World Health Organization (WHO), 2. draft guidance on "Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke" by the Food and Drug Administration (FDA), 3. HPHC specific to the source of exposure, 4. BoExp to an HPHC easily detectable using reliable, reproducible, precise analytical methods, 5. HPHC reflecting a specific toxic exposure or being a reliable surrogate of exposure to HPHCs, 6. the list of HPHCs including HPHCs from both gas and particulate phase, 7. the list of HPHCs including a broad variety of chemical classes and organ toxicity classes, 8. representing HPHCs formed at different temperature levels.


Criteria:

Inclusion Criteria: - Current healthy smoker as judged by the Principal Investigator(s) or designee(s). - Subject is aged from 30 to 65 years old (inclusive). - Subject has smoked for at least the last 10 years. - Subject smoked more than 10 cigarettes/day on average over the last year. - Subject is willing to quit smoking within the next 30 days. Exclusion Criteria: - Subject has clinically relevant medical conditions that in the opinion of the Investigators would jeopardize the safety of the participant or affect the validity of the study results. - Subject has (FEV1/FVC) < 0.7 and FEV1 < 80% predicted value at post-bronchodilator spirometry. - Subject with FEV1/FVC < 0.75 (post-bronchodilator) and reversibility in FEV1 that is both > 12% and > 200 ml from pre- to post-bronchodilator values. - Subject who took or is taking concomitant medication which may have an impact on the "smoker's heath profile". - Female subject is pregnant or is a breast-feeding. - Female subject does not agree to use an acceptable method of effective contraception.


NCT ID:

NCT02432729


Primary Contact:

Study Chair
Christelle Haziza, PhD
Philip Morris Products S.A.


Backup Contact:

N/A


Location Contact:

Charlotte, North Carolina 28262
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 19, 2017

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