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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02432729
Recruitment Status : Completed
First Posted : May 4, 2015
Results First Posted : August 26, 2019
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
Philip Morris Products S.A.

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).

Condition or disease
Cigarette Smoking

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.

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Study Type : Observational
Actual Enrollment : 1184 participants
Observational Model: Other
Time Perspective: Prospective
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
Actual Study Start Date : May 5, 2015
Actual Primary Completion Date : May 31, 2017
Actual Study Completion Date : April 27, 2018

Resource links provided by the National Library of Medicine


Group/Cohort
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.




Primary Outcome Measures :
  1. High Density Lipoprotein C (HDL-C). [ Time Frame: Baseline; 6 month; 12 month ]
    Concentrations of HDL-C measured in serum. Mean values are provided as descriptive statistics.

  2. Low-density Lipoprotein Cholesterol (LDL-C) [ Time Frame: Baseline; 6 month; 12 month ]
    Concentrations of LDL-C measured in serum. Mean values are provided as descriptive statistics.

  3. Apo A1 [ Time Frame: Baseline; 6 month; 12 month ]
    Concentrations of Apolipoprotein A1 measured in serum. Mean values are provided as descriptive statistics.

  4. Apo B [ Time Frame: Baseline; 6 month; 12 month ]
    Concentrations of Apolipoprotein B measured in serum. Mean values are provided as descriptive statistics.

  5. White Blood Cells (WBC). [ Time Frame: Baseline; 6 month; 12 month ]
    Concentrations of WBC measured in blood. Mean values are provided as descriptive statistics.

  6. Hs-CRP [ Time Frame: Baseline; 6 month; 12 month ]
    Concentrations of high sensitivity C-reactive protein (hs-CRP) measured in serum. Geometric mean values are provided as descriptive statistics.

  7. Homocysteine [ Time Frame: Baseline; 6 month; 12 month ]
    Concentrations of Homocysteine measured in plasma. Geometric mean values are provided as descriptive statistics.

  8. Fibrinogen [ Time Frame: Baseline; 6 month; 12 month ]
    Concentrations of Fibrinogen measured in plasma. Geometric mean values are provided as descriptive statistics.

  9. Platelets [ Time Frame: Baseline; 6 month; 12 month ]
    Concentrations of Platelets measured in plasma. Geometric mean values are provided as descriptive statistics.

  10. 11-dehydrothromboxane B2 (11-DTXB2). [ Time Frame: Baseline; 6 month; 12 month ]
    Concentrations measured in urine and expressed as concentration adjusted for creatinine. Geometric mean values are provided as descriptive statistics.

  11. 8-epi-prostaglandin F2α (8-epi-PGF2α). [ Time Frame: Baseline; 6 month; 12 month ]
    Concentrations of 8-epi-PGF2α measured in urine and expressed as concentration adjusted for creatinine. Geometric Means are provided as descriptive statistics.

  12. MPO [ Time Frame: Baseline; 6 month; 12 month ]
    Concentrations of Myeloperoxidase measured in serum. Geometric mean values are provided as descriptive statistics.

  13. Soluble Intercellular Adhesion Molecule 1 (sICAM-1). [ Time Frame: Baseline; 6 month; 12 month ]
    Concentrations of sICAM-1 measured in serum. Geometric mean values are provided as descriptive statistics.

  14. Albumin [ Time Frame: Baseline; 6 month; 12 month ]
    Concentrations of Albumin measured in urine and expressed as concentration adjusted for creatinine. Geometric mean values are provided as descriptive statistics.

  15. Carboxyhemoglobin (COHb). [ Time Frame: Baseline; 6 month; 12 month ]
    Carboxyhemoglobin (COHb) is assayed from whole blood. Expressed as % of saturation of hemoglobin. Geometric means are provided as descriptive statistics.

  16. HbA1c [ Time Frame: Baseline; 6 month; 12 month ]
    Glycosylated hemoglobin (HbA1c) is assayed from whole blood. Geometric means are provided as descriptive statistics.

  17. Forced Expiratory Volume in 1 Second (FEV1), Pre-bronchodilator and Expressed as Percentage Predicted (FEV1 %Pred). [ Time Frame: Baseline; 6 month; 12 month ]

    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.


  18. FEV1 Post-bronchodilator and Expressed as Percentage Predicted (FEV1 %Pred). [ Time Frame: Baseline; 6 month; 12 month ]

    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.


  19. Forced Vital Capacity (FVC) Pre-bronchodilator, Expressed as Percentage Predicted (FVC %Pred). [ Time Frame: Baseline; 6 month; 12 month ]

    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.


  20. FVC Post-bronchodilator, Expressed as Percentage Predicted (FVC %Pred). [ Time Frame: Baseline; 6 month; 12 month ]

    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.


  21. FEV1/FVC Pre-bronchodilator Expressed as a Ratio [ Time Frame: Baseline; 6 month; 12 month ]

    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.


  22. FEV1/FVC Post-bronchodilator Expressed as a Ratio [ Time Frame: Baseline; 6 month; 12 month ]

    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.


  23. FEF 25-75 Forced Expiratory Flow, Pre-bronchodilator, Expressed as Percentage Predicted (FEF 25-75 %Pred) [ Time Frame: Baseline; 6 month; 12 month ]

    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.


  24. FEF 25-75 Forced Expiratory Flow, Post-bronchodilator, Expressed as Percentage Predicted (FEF 25-75 %Pred) [ Time Frame: Baseline; 6 month; 12 month ]

    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.


  25. Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL). [ Time Frame: Baseline; 6 month; 12 month ]
    Concentrations of Total NNAL measured in urine and expressed as concentration adjusted for creatinine. Geometric means are provided as descriptive statistics.


Biospecimen Retention:   Samples Without DNA
Blood and urine bio-banking samples


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02432729


Locations
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United States, North Carolina
Rose Research Center
Charlotte, North Carolina, United States, 28262
Germany
Synexus Clinical Research GmbH
Frankfurt, Hessen, Germany, 60596
Japan
Clinical Research Tokyo Hospital
Tokyo, Japan, 162-0053
Poland
BioVirtus Research Site Sp. z o.o.
Kajetany, Poland, 05-830
United Kingdom
Synexus, Merseyside Clinical Research Centre
Liverpool, United Kingdom, L22 0LG
Sponsors and Collaborators
Philip Morris Products S.A.
Investigators
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Study Chair: Christelle Haziza, PhD Philip Morris Products S.A.
Principal Investigator: Christel Contzen, MD Synexus Clinical Research GmbH
Principal Investigator: Monika Tomaszewska-Kiecana, MD BioVirtus Research Site Sp. z o.o.
Principal Investigator: Susannah Eyre, MD Synexus, Merseyside Clinical Research Centre
Principal Investigator: Jed Rose, PhD Rose Research Center
Principal Investigator: Koichi Nakamura, MD Clinical Research Tokyo Hospital
  Study Documents (Full-Text)

Documents provided by Philip Morris Products S.A.:
Study Protocol  [PDF] May 18, 2017
Statistical Analysis Plan  [PDF] February 27, 2018

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Philip Morris Products S.A.
ClinicalTrials.gov Identifier: NCT02432729    
Other Study ID Numbers: SA-SCR-01
SA-SCR-01 ( Other Identifier: Philip Morris Products S.A. )
First Posted: May 4, 2015    Key Record Dates
Results First Posted: August 26, 2019
Last Update Posted: August 26, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Philip Morris Products S.A.:
smoking cessation
smoking abstinence
clinical, biological and functional changes
one year
healthy smokers
quit smoking