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

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ClinicalTrials.gov Identifier: NCT02432729
Recruitment Status : Completed
First Posted : May 4, 2015
Last Update Posted : May 8, 2018
Sponsor:
Information provided by (Responsible Party):
Philip Morris Products S.A.

Brief Summary:
The purpose of this study is 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).

Condition or disease
Cigarette Smoking

Detailed Description:

The BoExp to be measured are selected based on:

  1. HPHCs derived from the list of HPHCs recommended for lowering in cigarette smoke by the World Health Organization (WHO),
  2. draft guidance on "Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke" by the Food and Drug Administration (FDA),
  3. HPHC specific to the source of exposure,
  4. BoExp to an HPHC easily detectable using reliable, reproducible, precise analytical methods,
  5. HPHC reflecting a specific toxic exposure or being a reliable surrogate of exposure to HPHCs,
  6. the list of HPHCs including HPHCs from both gas and particulate phase,
  7. the list of HPHCs including a broad variety of chemical classes and organ toxicity classes,
  8. representing HPHCs formed at different temperature levels.

Study Type : Observational
Actual Enrollment : 1185 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 motivated 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. Levels of high density lipoprotein C (HDL-C). [ Time Frame: 52 Weeks ]
    Concentrations measured in serum. Geometric Least Squares means are provided as descriptive statistics.

  2. Levels of white blood cells (WBC). [ Time Frame: 52 Weeks ]
    Concentrations measured in blood. Geometric Least Squares means are provided as descriptive statistics.

  3. Post-bronchodilator forced expiratory volume in 1 second (FEV1). [ Time Frame: 52 Weeks ]
    FEV1 post-bronchodilator and expressed as percentage predicted (FEV1 %pred). Geometric Least Squares means are provided as descriptive statistics.

  4. Concentrations of soluble intercellular adhesion molecule 1 (sICAM-1). [ Time Frame: 52 Weeks ]
    Concentrations measured in serum. Geometric Least Squares means are provided as descriptive statistics.

  5. Concentrations of 11-dehydrothromboxane B2 (11-DTXB2). [ Time Frame: 52 Weeks ]
    Concentrations measured in urine and expressed as concentration adjusted for creatinine. Geometric Least Squares means are provided as descriptive statistics.

  6. Concentrations of 8-epi-prostaglandin F2α (8-epi-PGF2α). [ Time Frame: 52 Weeks ]
    Concentrations measured in urine and expressed as concentration adjusted for creatinine. Geometric Least Squares means are provided as descriptive statistics.

  7. Concentrations of total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (total NNAL). [ Time Frame: 52 Weeks ]
    Concentrations measured in urine and expressed as concentration adjusted for creatinine. Geometric Least Squares means are provided as descriptive statistics.

  8. Levels of carboxyhemoglobin (COHb). [ Time Frame: 52 Weeks ]
    Carboxyhemoglobin (COHb) is assayed from whole blood. Expressed as % of saturation of hemoglobin. Geometric Least Squares means are provided as descriptive statistics.


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


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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 (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 "smoker's heath profile".
  • Female subject is pregnant or is a breast-feeding.
  • Female subject does not agree to use an acceptable method of effective contraception.

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
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
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

Responsible Party: Philip Morris Products S.A.
ClinicalTrials.gov Identifier: NCT02432729     History of Changes
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
Last Update Posted: May 8, 2018
Last Verified: May 2018
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