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

NCT ID: NCT02432729

Last Updated: 2023-01-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1184 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-05-05
• Study Completion Date: 2018-04-27

Brief Summary

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).

Detailed Description

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.

Conditions

Cigarette Smoking

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Study population

Adult smokers who are willing to quit smoking within the next 30 days at the Screening Visit will be asked to continuously quit smoking for 1 year.

Smokers who are not continuously abstinent from smoking or any nicotine/tobacco containing product from the actual quit date will be discontinued from the study.

No interventions assigned to this group

Eligibility 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 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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Philip Morris Products S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christelle Haziza, PhD

Role: STUDY_CHAIR

Philip Morris Products S.A.

Christel Contzen, MD

Role: PRINCIPAL_INVESTIGATOR

Synexus Clinical Research GmbH

Monika Tomaszewska-Kiecana, MD

Role: PRINCIPAL_INVESTIGATOR

BioVirtus Research Site Sp. z o.o.

Susannah Eyre, MD

Role: PRINCIPAL_INVESTIGATOR

Synexus, Merseyside Clinical Research Centre

Jed Rose, PhD

Role: PRINCIPAL_INVESTIGATOR

Rose Research Center

Koichi Nakamura, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Research Tokyo Hospital

Locations

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

Countries

United States; Germany; Japan; Poland; United Kingdom

References

Tran CT, Felber Medlin L, Lama N, Taranu B, Ng W, Haziza C, Picavet P, Baker G, Ludicke F. Biological and Functional Changes in Healthy Adult Smokers Who Are Continuously Abstinent From Smoking for One Year: Protocol for a Prospective, Observational, Multicenter Cohort Study. JMIR Res Protoc. 2019 Jun 7;8(6):e12138. doi: 10.2196/12138.

Reference Type: BACKGROUND

PMID: 31199335 (View on PubMed)

Pouly, S., Haziza, C., Peck, M. J., & Peitsch, M. C. (2021). Clinical Assessment of ENDPs. In Toxicological Evaluation of Electronic Nicotine Delivery Products (pp. 385-459). Academic Press.

Reference Type: RESULT

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

SA-SCR-01

Identifier Type: OTHER

Identifier Source: secondary_id

SA-SCR-01

Identifier Type: -

Identifier Source: org_study_id