A Smoking Cessation Study to Understand the Biological and Functional Changes After One Year of Smoking Cessation

Completed

Conditions studied: Cigarette Smoking

In brief

The purpose of this study was 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) and biomarkers of effect (BoE).

Key facts

Study ID

NCT02432729

Run by

Philip Morris Products S.A.

People needed

1184

Starts

2015-05-05

Expected to finish

2018-04-27

Last updated by the study team

2023-01-30

Who can join

Age: 30 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 Forced Expiratory Volume in 1 second/Forced Vital Capacity(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 biomarkers of effect.
• Female subject is pregnant or is a breast-feeding.

Where it is running

• Rose Research Center — Charlotte, North Carolina, United States
• Synexus Clinical Research GmbH — Frankfurt am Main, Hesse, Germany
• Clinical Research Tokyo Hospital — Tokyo, Japan
• BioVirtus Research Site Sp. z o.o. — Kajetany, Poland
• Synexus, Merseyside Clinical Research Centre — Liverpool, United Kingdom

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.