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

Cigarette Smoking Clinical Trial

— RIBESC  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02432729
• Other study ID #: SA-SCR-01
• Secondary ID: SA-SCR-01
• Status: Completed
• Start date: May 5, 2015
• Est. completion date: April 27, 2018

Study information

• Verified date: January 2023
• Source: Philip Morris Products S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1184
• Est. completion date: April 27, 2018
• Est. primary completion date: May 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cigarette Smoking

Locations

Country	Name	City	State
Germany	Synexus Clinical Research GmbH	Frankfurt	Hessen
Japan	Clinical Research Tokyo Hospital	Tokyo
Poland	BioVirtus Research Site Sp. z o.o.	Kajetany
United Kingdom	Synexus, Merseyside Clinical Research Centre	Liverpool
United States	Rose Research Center	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Philip Morris Products S.A.

Countries where clinical trial is conducted

United States,  Germany,  Japan,  Poland,  United Kingdom, 

References & Publications (2)

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.

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	High Density Lipoprotein C (HDL-C).	Concentrations of HDL-C measured in serum. Mean values are provided as descriptive statistics.	Baseline; 6 month; 12 month
Primary	Low-density Lipoprotein Cholesterol (LDL-C)	Concentrations of LDL-C measured in serum. Mean values are provided as descriptive statistics.	Baseline; 6 month; 12 month
Primary	Apo A1	Concentrations of Apolipoprotein A1 measured in serum. Mean values are provided as descriptive statistics.	Baseline; 6 month; 12 month
Primary	Apo B	Concentrations of Apolipoprotein B measured in serum. Mean values are provided as descriptive statistics.	Baseline; 6 month; 12 month
Primary	White Blood Cells (WBC).	Concentrations of WBC measured in blood. Mean values are provided as descriptive statistics.	Baseline; 6 month; 12 month
Primary	Hs-CRP	Concentrations of high sensitivity C-reactive protein (hs-CRP) measured in serum. Geometric mean values are provided as descriptive statistics.	Baseline; 6 month; 12 month
Primary	Homocysteine	Concentrations of Homocysteine measured in plasma. Geometric mean values are provided as descriptive statistics.	Baseline; 6 month; 12 month
Primary	Fibrinogen	Concentrations of Fibrinogen measured in plasma. Geometric mean values are provided as descriptive statistics.	Baseline; 6 month; 12 month
Primary	Platelets	Concentrations of Platelets measured in plasma. Geometric mean values are provided as descriptive statistics.	Baseline; 6 month; 12 month
Primary	11-dehydrothromboxane B2 (11-DTXB2).	Concentrations measured in urine and expressed as concentration adjusted for creatinine. Geometric mean values are provided as descriptive statistics.	Baseline; 6 month; 12 month
Primary	8-epi-prostaglandin F2a (8-epi-PGF2a).	Concentrations of 8-epi-PGF2a measured in urine and expressed as concentration adjusted for creatinine. Geometric Means are provided as descriptive statistics.	Baseline; 6 month; 12 month
Primary	MPO	Concentrations of Myeloperoxidase measured in serum. Geometric mean values are provided as descriptive statistics.	Baseline; 6 month; 12 month
Primary	Soluble Intercellular Adhesion Molecule 1 (sICAM-1).	Concentrations of sICAM-1 measured in serum. Geometric mean values are provided as descriptive statistics.	Baseline; 6 month; 12 month
Primary	Albumin	Concentrations of Albumin measured in urine and expressed as concentration adjusted for creatinine. Geometric mean values are provided as descriptive statistics.	Baseline; 6 month; 12 month
Primary	Carboxyhemoglobin (COHb).	Carboxyhemoglobin (COHb) is assayed from whole blood. Expressed as % of saturation of hemoglobin. Geometric means are provided as descriptive statistics.	Baseline; 6 month; 12 month
Primary	HbA1c	Glycosylated hemoglobin (HbA1c) is assayed from whole blood. Geometric means are provided as descriptive statistics.	Baseline; 6 month; 12 month
Primary	Forced Expiratory Volume in 1 Second (FEV1), Pre-bronchodilator and Expressed as Percentage Predicted (FEV1 %Pred).	FEV1 pre-bronchodilator and expressed as percentage predicted (FEV1 %pred).; Mean values are provided as descriptive statistics.; Spirometry is a physiological test that measures how an individual inhales or exhales volumes of air as a function of time. The primary signal measured in spirometry may be volume or flow. The forced expiratory volume (FEV) in one second is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration.	Baseline; 6 month; 12 month
Primary	FEV1 Post-bronchodilator and Expressed as Percentage Predicted (FEV1 %Pred).	FEV1 post-bronchodilator and expressed as percentage predicted (FEV1 %pred). Mean values are provided as descriptive statistics.; Spirometry is a physiological test that measures how an individual inhales or exhales volumes of air as a function of time. The primary signal measured in spirometry may be volume or flow. The forced expiratory volume (FEV) in one second is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration.	Baseline; 6 month; 12 month
Primary	Forced Vital Capacity (FVC) Pre-bronchodilator, Expressed as Percentage Predicted (FVC %Pred).	Pre-bronchodilator Forced Vital Capacity, expressed as percentage predicted (FVC %pred). Mean values are provided as descriptive statistics.; Spirometry is a physiological test that measures how an individual inhales or exhales volumes of air as a function of time. The primary signal measured in spirometry may be volume or flow. The forced vital capacity (FVC) is the maximal volume of air exhaled with maximally forced effort from a maximal inspiration.	Baseline; 6 month; 12 month
Primary	FVC Post-bronchodilator, Expressed as Percentage Predicted (FVC %Pred).	Post-bronchodilator Forced Vital Capacity, expressed as percentage predicted (FVC %pred). Mean values are provided as descriptive statistics.; Spirometry is a physiological test that measures how an individual inhales or exhales volumes of air as a function of time. The primary signal measured in spirometry may be volume or flow. The forced vital capacity (FVC) is the maximal volume of air exhaled with maximally forced effort from a maximal inspiration.	Baseline; 6 month; 12 month
Primary	FEV1/FVC Pre-bronchodilator Expressed as a Ratio	Pre-bronchodilator FEV1/FVC expressed as a ratio. Mean values are provided as descriptive statistics.; Spirometry is a physiological test that measures how an individual inhales or exhales volumes of air as a function of time. The primary signal measured in spirometry may be volume or flow. The forced vital capacity (FVC) is the maximal volume of air exhaled with maximally forced effort from a maximal inspiration, and the forced expiratory volume (FEV) in one second is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration.	Baseline; 6 month; 12 month
Primary	FEV1/FVC Post-bronchodilator Expressed as a Ratio	Post-bronchodilator FEV1/FVC expressed as a ratio. Mean values are provided as descriptive statistics.; Spirometry is a physiological test that measures how an individual inhales or exhales volumes of air as a function of time. The primary signal measured in spirometry may be volume or flow. The forced vital capacity (FVC) is the maximal volume of air exhaled with maximally forced effort from a maximal inspiration, and the forced expiratory volume (FEV) in one second is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration.	Baseline; 6 month; 12 month
Primary	FEF 25-75 Forced Expiratory Flow, Pre-bronchodilator, Expressed as Percentage Predicted (FEF 25-75 %Pred)	Pre-bronchodilator FEF 25-75, expressed as percentage predicted (FEF 25-75 %pred). Mean values are provided as descriptive statistics.; Spirometry is a physiological test that measures how an individual inhales or exhales volumes of air as a function of time. The forced expiratory flow between 25% and 75% of the FVC (FEF25-75%) is defined as the forced expiratory flow during the middle half of the FVC; the average flow from the point at which 25% of the FVC has been exhaled to the point at which 75% of the FVC has been exhaled.	Baseline; 6 month; 12 month
Primary	FEF 25-75 Forced Expiratory Flow, Post-bronchodilator, Expressed as Percentage Predicted (FEF 25-75 %Pred)	Post-bronchodilator FEF 25-75, expressed as percentage predicted (FEF 25-75 %pred). Mean values are provided as descriptive statistics.; Spirometry is a physiological test that measures how an individual inhales or exhales volumes of air as a function of time. The forced expiratory flow between 25% and 75% of the FVC (FEF25-75%) is defined as the forced expiratory flow during the middle half of the FVC; the average flow from the point at which 25% of the FVC has been exhaled to the point at which 75% of the FVC has been exhaled.	Baseline; 6 month; 12 month
Primary	Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL).	Concentrations of Total NNAL measured in urine and expressed as concentration adjusted for creatinine. Geometric means are provided as descriptive statistics.	Baseline; 6 month; 12 month