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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02432729
Acronym
RIBESC
Enrollment
1184
Registered
2015-05-04
Start date
2015-05-05
Completion date
2018-04-27
Last updated
2023-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cigarette Smoking

Keywords

smoking cessation, smoking abstinence, clinical, biological and functional changes, one year, healthy smokers, quit smoking

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.

Interventions

None listed

Sponsors

Philip Morris Products S.A.
Lead SponsorINDUSTRY

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
High Density Lipoprotein C (HDL-C).Baseline; 6 month; 12 monthConcentrations of HDL-C measured in serum. Mean values are provided as descriptive statistics.
Low-density Lipoprotein Cholesterol (LDL-C)Baseline; 6 month; 12 monthConcentrations of LDL-C measured in serum. Mean values are provided as descriptive statistics.
Apo A1Baseline; 6 month; 12 monthConcentrations of Apolipoprotein A1 measured in serum. Mean values are provided as descriptive statistics.
Apo BBaseline; 6 month; 12 monthConcentrations of Apolipoprotein B measured in serum. Mean values are provided as descriptive statistics.
White Blood Cells (WBC).Baseline; 6 month; 12 monthConcentrations of WBC measured in blood. Mean values are provided as descriptive statistics.
Hs-CRPBaseline; 6 month; 12 monthConcentrations of high sensitivity C-reactive protein (hs-CRP) measured in serum. Geometric mean values are provided as descriptive statistics.
HomocysteineBaseline; 6 month; 12 monthConcentrations of Homocysteine measured in plasma. Geometric mean values are provided as descriptive statistics.
FibrinogenBaseline; 6 month; 12 monthConcentrations of Fibrinogen measured in plasma. Geometric mean values are provided as descriptive statistics.
PlateletsBaseline; 6 month; 12 monthConcentrations of Platelets measured in plasma. Geometric mean values are provided as descriptive statistics.
11-dehydrothromboxane B2 (11-DTXB2).Baseline; 6 month; 12 monthConcentrations 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).Baseline; 6 month; 12 monthConcentrations of 8-epi-PGF2α measured in urine and expressed as concentration adjusted for creatinine. Geometric Means are provided as descriptive statistics.
MPOBaseline; 6 month; 12 monthConcentrations of Myeloperoxidase measured in serum. Geometric mean values are provided as descriptive statistics.
Soluble Intercellular Adhesion Molecule 1 (sICAM-1).Baseline; 6 month; 12 monthConcentrations of sICAM-1 measured in serum. Geometric mean values are provided as descriptive statistics.
AlbuminBaseline; 6 month; 12 monthConcentrations of Albumin measured in urine and expressed as concentration adjusted for creatinine. Geometric mean values are provided as descriptive statistics.
Carboxyhemoglobin (COHb).Baseline; 6 month; 12 monthCarboxyhemoglobin (COHb) is assayed from whole blood. Expressed as % of saturation of hemoglobin. Geometric means are provided as descriptive statistics.
HbA1cBaseline; 6 month; 12 monthGlycosylated 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).Baseline; 6 month; 12 monthFEV1 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).Baseline; 6 month; 12 monthFEV1 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).Baseline; 6 month; 12 monthPre-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).Baseline; 6 month; 12 monthPost-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 RatioBaseline; 6 month; 12 monthPre-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 RatioBaseline; 6 month; 12 monthPost-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)Baseline; 6 month; 12 monthPre-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)Baseline; 6 month; 12 monthPost-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).Baseline; 6 month; 12 monthConcentrations of Total NNAL measured in urine and expressed as concentration adjusted for creatinine. Geometric means are provided as descriptive statistics.

Countries

Germany, Japan, Poland, United Kingdom, United States

Participant flow

Participants by arm

ArmCount
Enrolled
The Enrolled population included all subjects in the Full Safety Population, except 22 subjects enrolled at a site that was closed due to findings during a monitoring visit.
1,184
Total1,184

Baseline characteristics

CharacteristicEnrolled
Age, Continuous44.1 years
STANDARD_DEVIATION 8.87
BMI25.4 kg/m^2
STANDARD_DEVIATION 4.02
Height170 cm
STANDARD_DEVIATION 9.15
Race/Ethnicity, Customized
Ethnicity
Hispanic or Latino
73 Participants
Race/Ethnicity, Customized
Ethnicity
Japanese
335 Participants
Race/Ethnicity, Customized
Ethnicity
Not Hispanic or Latino
776 Participants
Race (NIH/OMB)
American Indian or Alaska Native
3 Participants
Race (NIH/OMB)
Asian
344 Participants
Race (NIH/OMB)
Black or African American
88 Participants
Race (NIH/OMB)
More than one race
3 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
Race (NIH/OMB)
White
744 Participants
Sex: Female, Male
Female
591 Participants
Sex: Female, Male
Male
593 Participants
Weight73.4 kg
STANDARD_DEVIATION 14.9

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
1 / 1,184
other
Total, other adverse events
313 / 1,184
serious
Total, serious adverse events
17 / 1,184

Outcome results

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.

Time frame: Baseline; 6 month; 12 month

Population: Some subjects were prematurely discontinued from the study. Non-compliance with smoking abstinence was the most frequently reported reason for premature discontinuation from the study.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Abstinence3m11-dehydrothromboxane B2 (11-DTXB2).Baseline (pg/mg creat)572 pg/mg creat
Abstinence3m11-dehydrothromboxane B2 (11-DTXB2).Month 6 (pg/mg creat)433 pg/mg creat
Abstinence3m11-dehydrothromboxane B2 (11-DTXB2).Month 12 (pg/mg creat)436 pg/mg creat
Primary

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.

Time frame: Baseline; 6 month; 12 month

Population: Some subjects were prematurely discontinued from the study. Non-compliance with smoking abstinence was the most frequently reported reason for premature discontinuation from the study.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Abstinence3m8-epi-prostaglandin F2α (8-epi-PGF2α).Baseline (pg/mg creat)242 pg/mg creat
Abstinence3m8-epi-prostaglandin F2α (8-epi-PGF2α).Month 6 (pg/mg creat)199 pg/mg creat
Abstinence3m8-epi-prostaglandin F2α (8-epi-PGF2α).Month 12 (pg/mg creat)189 pg/mg creat
Primary

Albumin

Concentrations of Albumin measured in urine and expressed as concentration adjusted for creatinine. Geometric mean values are provided as descriptive statistics.

Time frame: Baseline; 6 month; 12 month

Population: Some subjects were prematurely discontinued from the study. Non-compliance with smoking abstinence was the most frequently reported reason for premature discontinuation from the study.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Abstinence3mAlbuminBaseline (mg/g creat)5.68 mg/g creat
Abstinence3mAlbuminMonth 6 (mg/g creat)5.69 mg/g creat
Abstinence3mAlbuminMonth 12 (mg/g creat)5.51 mg/g creat
Primary

Apo A1

Concentrations of Apolipoprotein A1 measured in serum. Mean values are provided as descriptive statistics.

Time frame: Baseline; 6 month; 12 month

Population: Some subjects were prematurely discontinued from the study. Non-compliance with smoking abstinence was the most frequently reported reason for premature discontinuation from the study.

ArmMeasureGroupValue (MEAN)
Abstinence3mApo A1Baseline155 mg/dL
Abstinence3mApo A1Month 6158 mg/dL
Abstinence3mApo A1Month 12155 mg/dL
Primary

Apo B

Concentrations of Apolipoprotein B measured in serum. Mean values are provided as descriptive statistics.

Time frame: Baseline; 6 month; 12 month

Population: Some subjects were prematurely discontinued from the study. Non-compliance with smoking abstinence was the most frequently reported reason for premature discontinuation from the study.

ArmMeasureGroupValue (MEAN)
Abstinence3mApo BBaseline94.3 mg/dL
Abstinence3mApo BMonth 696.3 mg/dL
Abstinence3mApo BMonth 1297.5 mg/dL
Primary

Carboxyhemoglobin (COHb).

Carboxyhemoglobin (COHb) is assayed from whole blood. Expressed as % of saturation of hemoglobin. Geometric means are provided as descriptive statistics.

Time frame: Baseline; 6 month; 12 month

Population: Some subjects were prematurely discontinued from the study. Non-compliance with smoking abstinence was the most frequently reported reason for premature discontinuation from the study.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Abstinence3mCarboxyhemoglobin (COHb).Baseline2.78 percentage
Abstinence3mCarboxyhemoglobin (COHb).Month 60.724 percentage
Abstinence3mCarboxyhemoglobin (COHb).Month 120.758 percentage
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.

Time frame: Baseline; 6 month; 12 month

Population: Some subjects were prematurely discontinued from the study. Non-compliance with smoking abstinence was the most frequently reported reason for premature discontinuation from the study.

ArmMeasureGroupValue (MEAN)
Abstinence3mFEF 25-75 Forced Expiratory Flow, Post-bronchodilator, Expressed as Percentage Predicted (FEF 25-75 %Pred)Baseline95.7 Percent of predicted FEF 25-75%
Abstinence3mFEF 25-75 Forced Expiratory Flow, Post-bronchodilator, Expressed as Percentage Predicted (FEF 25-75 %Pred)Month 695.8 Percent of predicted FEF 25-75%
Abstinence3mFEF 25-75 Forced Expiratory Flow, Post-bronchodilator, Expressed as Percentage Predicted (FEF 25-75 %Pred)Month 1298.1 Percent of predicted FEF 25-75%
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.

Time frame: Baseline; 6 month; 12 month

Population: Some subjects were prematurely discontinued from the study. Non-compliance with smoking abstinence was the most frequently reported reason for premature discontinuation from the study.

ArmMeasureGroupValue (MEAN)
Abstinence3mFEF 25-75 Forced Expiratory Flow, Pre-bronchodilator, Expressed as Percentage Predicted (FEF 25-75 %Pred)Baseline84.8 Percent of predicted FEF 25-75%
Abstinence3mFEF 25-75 Forced Expiratory Flow, Pre-bronchodilator, Expressed as Percentage Predicted (FEF 25-75 %Pred)Month 684.2 Percent of predicted FEF 25-75%
Abstinence3mFEF 25-75 Forced Expiratory Flow, Pre-bronchodilator, Expressed as Percentage Predicted (FEF 25-75 %Pred)Month 1286.6 Percent of predicted FEF 25-75%
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.

Time frame: Baseline; 6 month; 12 month

Population: Some subjects were prematurely discontinued from the study. Non-compliance with smoking abstinence was the most frequently reported reason for premature discontinuation from the study.

ArmMeasureGroupValue (MEAN)
Abstinence3mFEV1/FVC Post-bronchodilator Expressed as a RatioBaseline0.796 ratio
Abstinence3mFEV1/FVC Post-bronchodilator Expressed as a RatioMonth 60.797 ratio
Abstinence3mFEV1/FVC Post-bronchodilator Expressed as a RatioMonth 120.803 ratio
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.

Time frame: Baseline; 6 month; 12 month

Population: Some subjects were prematurely discontinued from the study. Non-compliance with smoking abstinence was the most frequently reported reason for premature discontinuation from the study.

ArmMeasureGroupValue (MEAN)
Abstinence3mFEV1/FVC Pre-bronchodilator Expressed as a RatioBaseline0.771 ratio
Abstinence3mFEV1/FVC Pre-bronchodilator Expressed as a RatioMonth 60.77 ratio
Abstinence3mFEV1/FVC Pre-bronchodilator Expressed as a RatioMonth 120.778 ratio
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.

Time frame: Baseline; 6 month; 12 month

Population: Some subjects were prematurely discontinued from the study. Non-compliance with smoking abstinence was the most frequently reported reason for premature discontinuation from the study.

ArmMeasureGroupValue (MEAN)
Abstinence3mFEV1 Post-bronchodilator and Expressed as Percentage Predicted (FEV1 %Pred).Baseline97.1 Percent of predicted FEV1
Abstinence3mFEV1 Post-bronchodilator and Expressed as Percentage Predicted (FEV1 %Pred).Month 696.7 Percent of predicted FEV1
Abstinence3mFEV1 Post-bronchodilator and Expressed as Percentage Predicted (FEV1 %Pred).Month 1296.5 Percent of predicted FEV1
Primary

Fibrinogen

Concentrations of Fibrinogen measured in plasma. Geometric mean values are provided as descriptive statistics.

Time frame: Baseline; 6 month; 12 month

Population: Some subjects were prematurely discontinued from the study. Non-compliance with smoking abstinence was the most frequently reported reason for premature discontinuation from the study.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Abstinence3mFibrinogenBaseline (mg/dL)326 mg/dL
Abstinence3mFibrinogenMonth 6 (mg/dL)310 mg/dL
Abstinence3mFibrinogenMonth 12 (mg/dL)312 mg/dL
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.

Time frame: Baseline; 6 month; 12 month

Population: Some subjects were prematurely discontinued from the study. Non-compliance with smoking abstinence was the most frequently reported reason for premature discontinuation from the study.

ArmMeasureGroupValue (MEAN)
Abstinence3mForced Expiratory Volume in 1 Second (FEV1), Pre-bronchodilator and Expressed as Percentage Predicted (FEV1 %Pred).Baseline94.5 Percent of predicted FEV1
Abstinence3mForced Expiratory Volume in 1 Second (FEV1), Pre-bronchodilator and Expressed as Percentage Predicted (FEV1 %Pred).Month 694.2 Percent of predicted FEV1
Abstinence3mForced Expiratory Volume in 1 Second (FEV1), Pre-bronchodilator and Expressed as Percentage Predicted (FEV1 %Pred).Month 1293.9 Percent of predicted FEV1
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.

Time frame: Baseline; 6 month; 12 month

Population: Some subjects were prematurely discontinued from the study. Non-compliance with smoking abstinence was the most frequently reported reason for premature discontinuation from the study.

ArmMeasureGroupValue (MEAN)
Abstinence3mForced Vital Capacity (FVC) Pre-bronchodilator, Expressed as Percentage Predicted (FVC %Pred).Baseline101 Percent of predicted FVC
Abstinence3mForced Vital Capacity (FVC) Pre-bronchodilator, Expressed as Percentage Predicted (FVC %Pred).Month 6100 Percent of predicted FVC
Abstinence3mForced Vital Capacity (FVC) Pre-bronchodilator, Expressed as Percentage Predicted (FVC %Pred).Month 1299.1 Percent of predicted FVC
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.

Time frame: Baseline; 6 month; 12 month

Population: Some subjects were prematurely discontinued from the study. Non-compliance with smoking abstinence was the most frequently reported reason for premature discontinuation from the study.

ArmMeasureGroupValue (MEAN)
Abstinence3mFVC Post-bronchodilator, Expressed as Percentage Predicted (FVC %Pred).Baseline100 Percent of predicted FVC
Abstinence3mFVC Post-bronchodilator, Expressed as Percentage Predicted (FVC %Pred).Month 699.5 Percent of predicted FVC
Abstinence3mFVC Post-bronchodilator, Expressed as Percentage Predicted (FVC %Pred).Month 1298.6 Percent of predicted FVC
Primary

HbA1c

Glycosylated hemoglobin (HbA1c) is assayed from whole blood. Geometric means are provided as descriptive statistics.

Time frame: Baseline; 6 month; 12 month

Population: Some subjects were prematurely discontinued from the study. Non-compliance with smoking abstinence was the most frequently reported reason for premature discontinuation from the study.

ArmMeasureGroupValue (MEAN)
Abstinence3mHbA1cBaseline5.42 percentage of glycated hemoglobin
Abstinence3mHbA1cMonth 65.39 percentage of glycated hemoglobin
Abstinence3mHbA1cMonth 125.45 percentage of glycated hemoglobin
Primary

High Density Lipoprotein C (HDL-C).

Concentrations of HDL-C measured in serum. Mean values are provided as descriptive statistics.

Time frame: Baseline; 6 month; 12 month

Population: Some subjects were prematurely discontinued from the study. Non-compliance with smoking abstinence was the most frequently reported reason for premature discontinuation from the study.

ArmMeasureGroupValue (MEAN)
Abstinence3mHigh Density Lipoprotein C (HDL-C).Baseline57.1 mg/dL
Abstinence3mHigh Density Lipoprotein C (HDL-C).Month 658.9 mg/dL
Abstinence3mHigh Density Lipoprotein C (HDL-C).Month 1258.6 mg/dL
Primary

Homocysteine

Concentrations of Homocysteine measured in plasma. Geometric mean values are provided as descriptive statistics.

Time frame: Baseline; 6 month; 12 month

Population: Some subjects were prematurely discontinued from the study. Non-compliance with smoking abstinence was the most frequently reported reason for premature discontinuation from the study.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Abstinence3mHomocysteineBaseline (μmol/L)12.6 μmol/L
Abstinence3mHomocysteineMonth 6 (μmol/L)11.4 μmol/L
Abstinence3mHomocysteineMonth 12 (μmol/L)11.7 μmol/L
Primary

Hs-CRP

Concentrations of high sensitivity C-reactive protein (hs-CRP) measured in serum. Geometric mean values are provided as descriptive statistics.

Time frame: Baseline; 6 month; 12 month

Population: Some subjects were prematurely discontinued from the study. Non-compliance with smoking abstinence was the most frequently reported reason for premature discontinuation from the study.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Abstinence3mHs-CRPBaseline (mg/L)0.856 mg/L
Abstinence3mHs-CRPMonth 6 (mg/L)0.841 mg/L
Abstinence3mHs-CRPMonth 12 (mg/L)0.963 mg/L
Primary

Low-density Lipoprotein Cholesterol (LDL-C)

Concentrations of LDL-C measured in serum. Mean values are provided as descriptive statistics.

Time frame: Baseline; 6 month; 12 month

Population: Some subjects were prematurely discontinued from the study. Non-compliance with smoking abstinence was the most frequently reported reason for premature discontinuation from the study.

ArmMeasureGroupValue (MEAN)
Abstinence3mLow-density Lipoprotein Cholesterol (LDL-C)Baseline131 mg/dL
Abstinence3mLow-density Lipoprotein Cholesterol (LDL-C)Month 6136 mg/dL
Abstinence3mLow-density Lipoprotein Cholesterol (LDL-C)Month 12138 mg/dL
Primary

MPO

Concentrations of Myeloperoxidase measured in serum. Geometric mean values are provided as descriptive statistics.

Time frame: Baseline; 6 month; 12 month

Population: Some subjects were prematurely discontinued from the study. Non-compliance with smoking abstinence was the most frequently reported reason for premature discontinuation from the study.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Abstinence3mMPOBaseline (μg/L)133 μg/L
Abstinence3mMPOMonth 6 (μg/L)144 μg/L
Abstinence3mMPOMonth 12 (μg/L)202 μg/L
Primary

Platelets

Concentrations of Platelets measured in plasma. Geometric mean values are provided as descriptive statistics.

Time frame: Baseline; 6 month; 12 month

Population: Some subjects were prematurely discontinued from the study. Non-compliance with smoking abstinence was the most frequently reported reason for premature discontinuation from the study.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Abstinence3mPlateletsBaseline (GI/L)239 GI/L
Abstinence3mPlateletsMonth 6 (GI/L)240 GI/L
Abstinence3mPlateletsMonth 12 (GI/L)241 GI/L
Primary

Soluble Intercellular Adhesion Molecule 1 (sICAM-1).

Concentrations of sICAM-1 measured in serum. Geometric mean values are provided as descriptive statistics.

Time frame: Baseline; 6 month; 12 month

Population: Some subjects were prematurely discontinued from the study. Non-compliance with smoking abstinence was the most frequently reported reason for premature discontinuation from the study.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Abstinence3mSoluble Intercellular Adhesion Molecule 1 (sICAM-1).Baseline (ng/mL)229 ng/mL
Abstinence3mSoluble Intercellular Adhesion Molecule 1 (sICAM-1).Month 6 (ng/mL)201 ng/mL
Abstinence3mSoluble Intercellular Adhesion Molecule 1 (sICAM-1).Month 12 (ng/mL)194 ng/mL
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.

Time frame: Baseline; 6 month; 12 month

Population: Some subjects were prematurely discontinued from the study. Non-compliance with smoking abstinence was the most frequently reported reason for premature discontinuation from the study.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Abstinence3mTotal 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL).Baseline (pg/mg creat)125 pg/mg creat
Abstinence3mTotal 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL).Month 6 (pg/mg creat)5.11 pg/mg creat
Abstinence3mTotal 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL).Month 12 (pg/mg creat)4.37 pg/mg creat
Primary

White Blood Cells (WBC).

Concentrations of WBC measured in blood. Mean values are provided as descriptive statistics.

Time frame: Baseline; 6 month; 12 month

Population: Some subjects were prematurely discontinued from the study. Non-compliance with smoking abstinence was the most frequently reported reason for premature discontinuation from the study.

ArmMeasureGroupValue (MEAN)
Abstinence3mWhite Blood Cells (WBC).Baseline6.72 GI/L
Abstinence3mWhite Blood Cells (WBC).Month 65.94 GI/L
Abstinence3mWhite Blood Cells (WBC).Month 125.93 GI/L

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026