Clinical trial NCT02432729: A Smoking Cessation Study to Understand the Biological and Functional Changes After One Year of Smoking Cessation
Official title: A Multi-center, Multi-region Smoking Cessation Study to Understand the Biological and Functional Changes Related to Smoking Cessation in Healthy Smokers Who Are Continuously Abstinent From Smoking for One Year
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cigarette Smoking
Keywords: smoking cessation
smoking abstinence
clinical, biological and functional changes
one year
healthy smokers
quit smoking
Lead sponsor: Philip Morris Products S.A.
Sponsor class: INDUSTRY
First posted: 2015-05-04
Enrollment: 1184
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult, smoking subjects willing to quit smoking with no restriction on race and ethnicities will be enrolled in this study.

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.

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.

Primary outcomes:
measure: High Density Lipoprotein C (HDL-C).
timeFrame: Baseline; 6 month; 12 month
measure: Low-density Lipoprotein Cholesterol (LDL-C)
timeFrame: Baseline; 6 month; 12 month
measure: Apo A1
timeFrame: Baseline; 6 month; 12 month
measure: Apo B
timeFrame: Baseline; 6 month; 12 month
measure: White Blood Cells (WBC).
timeFrame: Baseline; 6 month; 12 month
measure: Hs-CRP
timeFrame: Baseline; 6 month; 12 month
measure: Homocysteine
timeFrame: Baseline; 6 month; 12 month
measure: Fibrinogen
timeFrame: Baseline; 6 month; 12 month
measure: Platelets
timeFrame: Baseline; 6 month; 12 month
measure: 11-dehydrothromboxane B2 (11-DTXB2).
timeFrame: Baseline; 6 month; 12 month
measure: 8-epi-prostaglandin F2α (8-epi-PGF2α).
timeFrame: Baseline; 6 month; 12 month
measure: MPO
timeFrame: Baseline; 6 month; 12 month
measure: Soluble Intercellular Adhesion Molecule 1 (sICAM-1).
timeFrame: Baseline; 6 month; 12 month
measure: Albumin
timeFrame: Baseline; 6 month; 12 month
measure: Carboxyhemoglobin (COHb).
timeFrame: Baseline; 6 month; 12 month
measure: HbA1c
timeFrame: Baseline; 6 month; 12 month
measure: Forced Expiratory Volume in 1 Second (FEV1), Pre-bronchodilator and Expressed as Percentage Predicted (FEV1 %Pred).
timeFrame: Baseline; 6 month; 12 month
measure: FEV1 Post-bronchodilator and Expressed as Percentage Predicted (FEV1 %Pred).
timeFrame: Baseline; 6 month; 12 month
measure: Forced Vital Capacity (FVC) Pre-bronchodilator, Expressed as Percentage Predicted (FVC %Pred).
timeFrame: Baseline; 6 month; 12 month
measure: FVC Post-bronchodilator, Expressed as Percentage Predicted (FVC %Pred).
timeFrame: Baseline; 6 month; 12 month
measure: FEV1/FVC Pre-bronchodilator Expressed as a Ratio
timeFrame: Baseline; 6 month; 12 month
measure: FEV1/FVC Post-bronchodilator Expressed as a Ratio
timeFrame: Baseline; 6 month; 12 month
measure: FEF 25-75 Forced Expiratory Flow, Pre-bronchodilator, Expressed as Percentage Predicted (FEF 25-75 %Pred)
timeFrame: Baseline; 6 month; 12 month
measure: FEF 25-75 Forced Expiratory Flow, Post-bronchodilator, Expressed as Percentage Predicted (FEF 25-75 %Pred)
timeFrame: Baseline; 6 month; 12 month
measure: Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL).
timeFrame: Baseline; 6 month; 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Rose Research Center
state: North Carolina
city: Frankfurt
country: Germany
facility: Synexus Clinical Research GmbH
state: Hessen
city: Tokyo
country: Japan
facility: Clinical Research Tokyo Hospital
city: Kajetany
country: Poland
facility: BioVirtus Research Site Sp. z o.o.
city: Liverpool
country: United Kingdom
facility: Synexus, Merseyside Clinical Research Centre
Study officials:
affiliation: Philip Morris Products S.A.
name: Christelle Haziza, PhD
role: STUDY_CHAIR
affiliation: Synexus Clinical Research GmbH
name: Christel Contzen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: BioVirtus Research Site Sp. z o.o.
name: Monika Tomaszewska-Kiecana, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Synexus, Merseyside Clinical Research Centre
name: Susannah Eyre, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rose Research Center
name: Jed Rose, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Research Tokyo Hospital
name: Koichi Nakamura, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.