A Smoking Cessation Study to Understand the Biological and Functional Changes After One Year of Smoking Cessation
A Smoking Cessation Study to Understand the Biological and Functional Changes After One Year of Smoking Cessation
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).
This was a 12 month, multi-region, multi-center, ambulatory study conducted in the US, Japan
 and Europe. Smokers who were willing to quit smoking within the next 30 days at the Screening
 Visit were enrolled to reach approximately 950 subjects continuously abstinent from smoking
 from Actual Quit Date (AQD) onwards at week 2, in order to achieve at least 190 successful
 quitters expected to complete the study. Once approximately 950 subjects reached week 2,
 screening and enrollment were stopped.

 Compliance with smoking abstinence was verified by self-reporting, CO breath tests, and urine
 cotinine tests. Smokers who were not continuously abstinent from smoking [i.e., free from
 tobacco product use (e.g., CC, pipes, cigars, snus) or any nicotine-containing product
 (including electronic cigarettes) other than nicotine replacement therapy (NRT)] from their
 AQD onwards were discontinued from the study. At the end of the study, 358 subjects were
 verified as continuously abstinent from their AQD.
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 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.