Cigarette SmokingRIBESCNCT02432729
A Smoking Cessation Study to Understand the Biological and Functional Changes After One Year of Smoking Cessation
An observational study of Cigarette Smoking, run by Philip Morris Products S.A. at 5 sites in 5 countries.
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). Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking
- How many people
- 1,184 participants
- Where
- 5 sitesin 5 countries
- Study dates
- 5 May 2015to 27 Apr 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult, smoking subjects willing to quit smoking with no restriction on race and ethnicities will be enrolled in this study.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
United States1 site
Rose Research Center
Charlotte, North Carolina, 28262
United Kingdom1 site
Synexus, Merseyside Clinical Research Centre
Liverpool, L22 0LG
About this study
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
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).
Read the 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
- Keywords
- smoking cessation, smoking abstinence, clinical, biological and functional changes, one year, healthy smokers, quit smoking
- Medical subject headings
- Cigarette Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
High Density Lipoprotein C (HDL-C).
Concentrations of HDL-C measured in serum. Mean values are provided as descriptive statistics.
Measured: Baseline; 6 month; 12 month
Low-density Lipoprotein Cholesterol (LDL-C)
Concentrations of LDL-C measured in serum. Mean values are provided as descriptive statistics.
Measured: Baseline; 6 month; 12 month
Apo A1
Concentrations of Apolipoprotein A1 measured in serum. Mean values are provided as descriptive statistics.
Measured: Baseline; 6 month; 12 month
Apo B
Concentrations of Apolipoprotein B measured in serum. Mean values are provided as descriptive statistics.
Measured: Baseline; 6 month; 12 month
White Blood Cells (WBC).
Concentrations of WBC measured in blood. Mean values are provided as descriptive statistics.
Measured: Baseline; 6 month; 12 month
Hs-CRP
Concentrations of high sensitivity C-reactive protein (hs-CRP) measured in serum. Geometric mean values are provided as descriptive statistics.
Measured: Baseline; 6 month; 12 month
Homocysteine
Concentrations of Homocysteine measured in plasma. Geometric mean values are provided as descriptive statistics.
Measured: Baseline; 6 month; 12 month
Fibrinogen
Concentrations of Fibrinogen measured in plasma. Geometric mean values are provided as descriptive statistics.
Measured: Baseline; 6 month; 12 month
Platelets
Concentrations of Platelets measured in plasma. Geometric mean values are provided as descriptive statistics.
Measured: Baseline; 6 month; 12 month
11-dehydrothromboxane B2 (11-DTXB2).
Concentrations measured in urine and expressed as concentration adjusted for creatinine. Geometric mean values are provided as descriptive statistics.
Measured: Baseline; 6 month; 12 month
8-epi-prostaglandin F2α (8-epi-PGF2α).
Concentrations of 8-epi-PGF2α measured in urine and expressed as concentration adjusted for creatinine. Geometric Means are provided as descriptive statistics.
Measured: Baseline; 6 month; 12 month
MPO
Concentrations of Myeloperoxidase measured in serum. Geometric mean values are provided as descriptive statistics.
Measured: Baseline; 6 month; 12 month
Soluble Intercellular Adhesion Molecule 1 (sICAM-1).
Concentrations of sICAM-1 measured in serum. Geometric mean values are provided as descriptive statistics.
Measured: Baseline; 6 month; 12 month
Albumin
Concentrations of Albumin measured in urine and expressed as concentration adjusted for creatinine. Geometric mean values are provided as descriptive statistics.
Measured: Baseline; 6 month; 12 month
Carboxyhemoglobin (COHb).
Carboxyhemoglobin (COHb) is assayed from whole blood. Expressed as % of saturation of hemoglobin. Geometric means are provided as descriptive statistics.
Measured: Baseline; 6 month; 12 month
HbA1c
Glycosylated hemoglobin (HbA1c) is assayed from whole blood. Geometric means are provided as descriptive statistics.
Measured: Baseline; 6 month; 12 month
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.
Measured: Baseline; 6 month; 12 month
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.
Measured: Baseline; 6 month; 12 month
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.
Measured: Baseline; 6 month; 12 month
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.
Measured: Baseline; 6 month; 12 month
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.
Measured: Baseline; 6 month; 12 month
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.
Measured: Baseline; 6 month; 12 month
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.
Measured: Baseline; 6 month; 12 month
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.
Measured: Baseline; 6 month; 12 month
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.
Measured: Baseline; 6 month; 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2015 (estimated)
- Study start5 May 2015
- Primary completion31 May 2017
- Study completion27 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cigarette SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philip Morris Products S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christelle Haziza, PhD, Study chair, Philip Morris Products S.A.Christel Contzen, MD, Principal investigator, Synexus Clinical Research GmbHMonika Tomaszewska-Kiecana, MD, Principal investigator, BioVirtus Research Site Sp. z o.o.Susannah Eyre, MD, Principal investigator, Synexus, Merseyside Clinical Research CentreJed Rose, PhD, Principal investigator, Rose Research CenterKoichi Nakamura, MD, Principal investigator, Clinical Research Tokyo Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02432729
- Sponsor's protocol ID
- SA-SCR-01
- Other IDs
- SA-SCR-01
- Acronym
- RIBESC
- Status last verified
- Jan 2023
- First submitted
- 14 Apr 2015
- Last updated
- 30 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 31199335Pouly, 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02432729
- Acronym / sponsor ID
- RIBESC / SA-SCR-01
- Conditions
- Cigarette Smoking
- Keywords
- smoking cessation, smoking abstinence, clinical, biological and functional changes, one year, healthy smokers, quit smoking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,184 participants (actual)
- Lead sponsor
- Philip Morris Products S.A.Industry (pharma, biotech, devices)
- Study start
- 5 May 2015 (actual)
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 27 Apr 2018 (actual)
- First posted
- 4 May 2015 (estimated)
- Results
- Posted 26 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult, smoking subjects willing to quit smoking with no restriction on race and ethnicities will be enrolled in this study.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Apo A1
Time frame: Baseline; 6 month; 12 month
Concentrations of Apolipoprotein A1 measured in serum. Mean values are provided as descriptive statistics.
Apo B
Time frame: Baseline; 6 month; 12 month
Concentrations of Apolipoprotein B measured in serum. Mean values are provided as descriptive statistics.
White Blood Cells (WBC).
Time frame: Baseline; 6 month; 12 month
Concentrations of WBC measured in blood. Mean values are provided as descriptive statistics.
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.
Homocysteine
Time frame: Baseline; 6 month; 12 month
Concentrations of Homocysteine measured in plasma. Geometric mean values are provided as descriptive statistics.
Fibrinogen
Time frame: Baseline; 6 month; 12 month
Concentrations of Fibrinogen measured in plasma. Geometric mean values are provided as descriptive statistics.
Platelets
Time frame: Baseline; 6 month; 12 month
Concentrations of Platelets measured in plasma. Geometric mean values are provided as descriptive statistics.
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.
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.
MPO
Time frame: Baseline; 6 month; 12 month
Concentrations of Myeloperoxidase measured in serum. Geometric mean values are provided as descriptive statistics.
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.
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.
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.
HbA1c
Time frame: Baseline; 6 month; 12 month
Glycosylated hemoglobin (HbA1c) is assayed from whole blood. Geometric means are provided as descriptive statistics.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 31199335Tran 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.
- Results publicationPouly, 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.
- Individual participant dataSharing planned: No
Related trials for Cigarette Smoking
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingPhase 3
iCanQuit Smoking Cessation Among Hispanic Adults
Cigarette Smoking-Related Carcinoma
RecruitingEarly Phase 1
Role of Inflammation in Vascular Phenotype Associated With E-cigarette Use
Electronic Cigarette Use, Endothelial Dysfunction
Not yet recruiting
Studying Different Ways of Using Oral Nicotine Pouches to Understand the Effect on Nicotine Delivery, Appeal, and Side Effects Among Adult Cigarette Smokers
Cigarette Smoking-Related Carcinoma
Not yet recruiting
Flavored Electronic Nicotine Delivery Systems to Lower Smoking and Exposure to Tobacco Toxicants Among Cigarette Smokers Interested in Quitting, REFLECT Trial
Tobacco Cessation, Electronic Nicotine Delivery Systems
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christelle Haziza, PhD study chair
Philip Morris Products S.A.
Christel Contzen, MD principal investigator
Synexus Clinical Research GmbH
Monika Tomaszewska-Kiecana, MD principal investigator
BioVirtus Research Site Sp. z o.o.
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cigarette Smoking, run by Philip Morris Products S.A. at 5 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Germany, Japan, Poland, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High Density Lipoprotein C (HDL-C). (time frame: Baseline; 6 month; 12 month). The study lists 25 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02432729, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2023.