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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 : January 30, 2023
Sponsor:
Information provided by (Responsible Party):
Philip Morris Products S.A.

Study Type Observational
Study Design Observational Model: Other;   Time Perspective: Prospective
Condition Cigarette Smoking
Enrollment 1184
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Abstinence3m Set
Hide Arm/Group Description Enrolled subjects, who were abstinent from smoking from their actual quit date to at least Month 3, were included in the Abstinence3m set.
Period Title: Month 3 Visit
Started 720
Completed 718
Not Completed 2
Period Title: Month 6 Visit
Started 718
Completed 632
Not Completed 86
Period Title: Month 12 Visit
Started 632
Completed 436
Not Completed 196
Arm/Group Title Enrolled
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 1184
Hide Baseline Analysis Population Description
All Regions
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1184 participants
44.1  (8.87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1184 participants
Female
591
  49.9%
Male
593
  50.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1184 participants
American Indian or Alaska Native
3
   0.3%
Asian
344
  29.1%
Native Hawaiian or Other Pacific Islander
1
   0.1%
Black or African American
88
   7.4%
White
744
  62.8%
More than one race
3
   0.3%
Unknown or Not Reported
1
   0.1%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Ethnicity Number Analyzed 1184 participants
Hispanic or Latino
73
   6.2%
Not Hispanic or Latino
776
  65.5%
Japanese
335
  28.3%
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 1184 participants
73.4  (14.9)
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 1184 participants
170  (9.15)
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 1184 participants
25.4  (4.02)
1.Primary Outcome
Title High Density Lipoprotein C (HDL-C).
Hide Description Concentrations of HDL-C measured in serum. Mean values are provided as descriptive statistics.
Time Frame Baseline; 6 month; 12 month
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Abstinence3m
Hide Arm/Group Description:
The Abstinence3m Set refers to enrolled subjects who were abstinent from smoking from their actual quit date to Month 3 (V8) or later.
Overall Number of Participants Analyzed 720
Mean (95% Confidence Interval)
Unit of Measure: mg/dL
Baseline Number Analyzed 710 participants
57.1
(55.8 to 58.4)
Month 6 Number Analyzed 410 participants
58.9
(57.1 to 60.7)
Month 12 Number Analyzed 328 participants
58.6
(56.6 to 60.5)
2.Primary Outcome
Title Low-density Lipoprotein Cholesterol (LDL-C)
Hide Description Concentrations of LDL-C measured in serum. Mean values are provided as descriptive statistics.
Time Frame Baseline; 6 month; 12 month
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Abstinence3m Set
Hide Arm/Group Description:
Enrolled subjects, who were abstinent from smoking from their actual quit date to Month 3, were included in the Abstinence3m set.
Overall Number of Participants Analyzed 720
Mean (95% Confidence Interval)
Unit of Measure: mg/dL
Baseline Number Analyzed 649 participants
131
(128 to 134)
Month 6 Number Analyzed 440 participants
136
(132 to 140)
Month 12 Number Analyzed 355 participants
138
(134 to 142)
3.Primary Outcome
Title Apo A1
Hide Description Concentrations of Apolipoprotein A1 measured in serum. Mean values are provided as descriptive statistics.
Time Frame Baseline; 6 month; 12 month
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Abstinence3m Set
Hide Arm/Group Description:
Enrolled subjects, who were abstinent from smoking from their actual quit date to Month 3, were included in the Abstinence3m set.
Overall Number of Participants Analyzed 720
Mean (95% Confidence Interval)
Unit of Measure: mg/dL
Baseline Number Analyzed 710 participants
155
(153 to 158)
Month 6 Number Analyzed 441 participants
158
(155 to 161)
Month 12 Number Analyzed 356 participants
155
(152 to 158)
4.Primary Outcome
Title Apo B
Hide Description Concentrations of Apolipoprotein B measured in serum. Mean values are provided as descriptive statistics.
Time Frame Baseline; 6 month; 12 month
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Abstinence3m Set
Hide Arm/Group Description:
Enrolled subjects, who were abstinent from smoking from their actual quit date to Month 3, were included in the Abstinence3m set.
Overall Number of Participants Analyzed 720
Mean (95% Confidence Interval)
Unit of Measure: mg/dL
Baseline Number Analyzed 712 participants
94.3
(92.4 to 96.2)
Month 6 Number Analyzed 441 participants
96.3
(93.8 to 98.7)
Month 12 Number Analyzed 356 participants
97.5
(94.8 to 100)
5.Primary Outcome
Title White Blood Cells (WBC).
Hide Description Concentrations of WBC measured in blood. Mean values are provided as descriptive statistics.
Time Frame Baseline; 6 month; 12 month
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Abstinence3m Set
Hide Arm/Group Description:
Enrolled subjects, who were abstinent from smoking from their actual quit date to Month 3, were included in the Abstinence3m set.
Overall Number of Participants Analyzed 720
Mean (95% Confidence Interval)
Unit of Measure: GI/L
Baseline Number Analyzed 717 participants
6.72
(6.58 to 6.86)
Month 6 Number Analyzed 440 participants
5.94
(5.79 to 6.09)
Month 12 Number Analyzed 355 participants
5.93
(5.75 to 6.11)
6.Primary Outcome
Title Hs-CRP
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Abstinence3m Set
Hide Arm/Group Description:
Enrolled subjects, who were abstinent from smoking from their actual quit date to Month 3, were included in the Abstinence3m set.
Overall Number of Participants Analyzed 720
Geometric Mean (95% Confidence Interval)
Unit of Measure: mg/L
Baseline (mg/L) Number Analyzed 659 participants
0.856
(0.776 to 0.944)
Month 6 (mg/L) Number Analyzed 441 participants
0.841
(0.752 to 0.941)
Month 12 (mg/L) Number Analyzed 356 participants
0.963
(0.846 to 1.1)
7.Primary Outcome
Title Homocysteine
Hide Description Concentrations of Homocysteine measured in plasma. Geometric mean values are provided as descriptive statistics.
Time Frame Baseline; 6 month; 12 month
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Abstinence3m Set
Hide Arm/Group Description:
Enrolled subjects, who were abstinent from smoking from their actual quit date to Month 3, were included in the Abstinence3m set.
Overall Number of Participants Analyzed 720
Geometric Mean (95% Confidence Interval)
Unit of Measure: μmol/L
Baseline (μmol/L) Number Analyzed 711 participants
12.6
(12.3 to 12.9)
Month 6 (μmol/L) Number Analyzed 442 participants
11.4
(11.1 to 11.8)
Month 12 (μmol/L) Number Analyzed 356 participants
11.7
(11.3 to 12)
8.Primary Outcome
Title Fibrinogen
Hide Description Concentrations of Fibrinogen measured in plasma. Geometric mean values are provided as descriptive statistics.
Time Frame Baseline; 6 month; 12 month
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Abstinence3m Set
Hide Arm/Group Description:
Enrolled subjects, who were abstinent from smoking from their actual quit date to Month 3, were included in the Abstinence3m set.
Overall Number of Participants Analyzed 720
Geometric Mean (95% Confidence Interval)
Unit of Measure: mg/dL
Baseline (mg/dL) Number Analyzed 645 participants
326
(321 to 331)
Month 6 (mg/dL) Number Analyzed 424 participants
310
(304 to 316)
Month 12 (mg/dL) Number Analyzed 348 participants
312
(305 to 319)
9.Primary Outcome
Title Platelets
Hide Description Concentrations of Platelets measured in plasma. Geometric mean values are provided as descriptive statistics.
Time Frame Baseline; 6 month; 12 month
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Abstinence3m Set
Hide Arm/Group Description:
Enrolled subjects, who were abstinent from smoking from their actual quit date to Month 3, were included in the Abstinence3m set.
Overall Number of Participants Analyzed 720
Geometric Mean (95% Confidence Interval)
Unit of Measure: GI/L
Baseline (GI/L) Number Analyzed 717 participants
239
(235 to 243)
Month 6 (GI/L) Number Analyzed 439 participants
240
(235 to 245)
Month 12 (GI/L) Number Analyzed 352 participants
241
(236 to 246)
10.Primary Outcome
Title 11-dehydrothromboxane B2 (11-DTXB2).
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Abstinence3m Set
Hide Arm/Group Description:
Enrolled subjects, who were abstinent from smoking from their actual quit date to Month 3, were included in the Abstinence3m set.
Overall Number of Participants Analyzed 720
Geometric Mean (95% Confidence Interval)
Unit of Measure: pg/mg creat
Baseline (pg/mg creat) Number Analyzed 543 participants
572
(546 to 601)
Month 6 (pg/mg creat) Number Analyzed 437 participants
433
(409 to 458)
Month 12 (pg/mg creat) Number Analyzed 352 participants
436
(411 to 463)
11.Primary Outcome
Title 8-epi-prostaglandin F2α (8-epi-PGF2α).
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Abstinence3m Set
Hide Arm/Group Description:
Enrolled subjects, who were abstinent from smoking from their actual quit date to Month 3, were included in the Abstinence3m set.
Overall Number of Participants Analyzed 720
Geometric Mean (95% Confidence Interval)
Unit of Measure: pg/mg creat
Baseline (pg/mg creat) Number Analyzed 548 participants
242
(233 to 251)
Month 6 (pg/mg creat) Number Analyzed 443 participants
199
(190 to 207)
Month 12 (pg/mg creat) Number Analyzed 357 participants
189
(180 to 197)
12.Primary Outcome
Title MPO
Hide Description Concentrations of Myeloperoxidase measured in serum. Geometric mean values are provided as descriptive statistics.
Time Frame Baseline; 6 month; 12 month
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Abstinence3m Set
Hide Arm/Group Description:
Enrolled subjects, who were abstinent from smoking from their actual quit date to Month 3, were included in the Abstinence3m set.
Overall Number of Participants Analyzed 720
Geometric Mean (95% Confidence Interval)
Unit of Measure: μg/L
Baseline (μg/L) Number Analyzed 716 participants
133
(126 to 140)
Month 6 (μg/L) Number Analyzed 442 participants
144
(133 to 155)
Month 12 (μg/L) Number Analyzed 356 participants
202
(187 to 217)
13.Primary Outcome
Title Soluble Intercellular Adhesion Molecule 1 (sICAM-1).
Hide Description Concentrations of sICAM-1 measured in serum. Geometric mean values are provided as descriptive statistics.
Time Frame Baseline; 6 month; 12 month
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Abstinence3m Set
Hide Arm/Group Description:
Enrolled subjects, who were abstinent from smoking from their actual quit date to Month 3, were included in the Abstinence3m set.
Overall Number of Participants Analyzed 720
Geometric Mean (95% Confidence Interval)
Unit of Measure: ng/mL
Baseline (ng/mL) Number Analyzed 661 participants
229
(223 to 236)
Month 6 (ng/mL) Number Analyzed 442 participants
201
(195 to 207)
Month 12 (ng/mL) Number Analyzed 356 participants
194
(187 to 200)
14.Primary Outcome
Title Albumin
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Abstinence3m Set
Hide Arm/Group Description:
Enrolled subjects, who were abstinent from smoking from their actual quit date to Month 3, were included in the Abstinence3m set.
Overall Number of Participants Analyzed 720
Geometric Mean (95% Confidence Interval)
Unit of Measure: mg/g creat
Baseline (mg/g creat) Number Analyzed 579 participants
5.68
(5.36 to 6.03)
Month 6 (mg/g creat) Number Analyzed 443 participants
5.69
(5.28 to 6.13)
Month 12 (mg/g creat) Number Analyzed 356 participants
5.51
(5.12 to 5.94)
15.Primary Outcome
Title Carboxyhemoglobin (COHb).
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Abstinence3m Set
Hide Arm/Group Description:
Enrolled subjects, who were abstinent from smoking from their actual quit date to Month 3, were included in the Abstinence3m set.
Overall Number of Participants Analyzed 720
Geometric Mean (95% Confidence Interval)
Unit of Measure: percentage
Baseline Number Analyzed 424 participants
2.78
(2.61 to 2.96)
Month 6 Number Analyzed 417 participants
0.724
(0.664 to 0.789)
Month 12 Number Analyzed 352 participants
0.758
(0.691 to 0.831)
16.Primary Outcome
Title HbA1c
Hide Description Glycosylated hemoglobin (HbA1c) is assayed from whole blood. Geometric means are provided as descriptive statistics.
Time Frame Baseline; 6 month; 12 month
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Abstinence3m Set
Hide Arm/Group Description:
Enrolled subjects, who were abstinent from smoking from their actual quit date to Month 3, were included in the Abstinence3m set.
Overall Number of Participants Analyzed 720
Mean (95% Confidence Interval)
Unit of Measure: percentage of glycated hemoglobin
Baseline Number Analyzed 713 participants
5.42
(5.39 to 5.44)
Month 6 Number Analyzed 439 participants
5.39
(5.36 to 5.42)
Month 12 Number Analyzed 354 participants
5.45
(5.42 to 5.49)
17.Primary Outcome
Title Forced Expiratory Volume in 1 Second (FEV1), Pre-bronchodilator and Expressed as Percentage Predicted (FEV1 %Pred).
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Abstinence3m Set
Hide Arm/Group Description:
Enrolled subjects, who were abstinent from smoking from their actual quit date to Month 3, were included in the Abstinence3m set.
Overall Number of Participants Analyzed 720
Mean (95% Confidence Interval)
Unit of Measure: Percent of predicted FEV1
Baseline Number Analyzed 674 participants
94.5
(93.7 to 95.4)
Month 6 Number Analyzed 437 participants
94.2
(93.1 to 95.4)
Month 12 Number Analyzed 334 participants
93.9
(92.6 to 95.3)
18.Primary Outcome
Title FEV1 Post-bronchodilator and Expressed as Percentage Predicted (FEV1 %Pred).
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Abstinence3m Set
Hide Arm/Group Description:
Enrolled subjects, who were abstinent from smoking from their actual quit date to Month 3, were included in the Abstinence3m set.
Overall Number of Participants Analyzed 720
Mean (95% Confidence Interval)
Unit of Measure: Percent of predicted FEV1
Baseline Number Analyzed 673 participants
97.1
(96.2 to 98)
Month 6 Number Analyzed 437 participants
96.7
(95.6 to 97.9)
Month 12 Number Analyzed 334 participants
96.5
(95.2 to 97.8)
19.Primary Outcome
Title Forced Vital Capacity (FVC) Pre-bronchodilator, Expressed as Percentage Predicted (FVC %Pred).
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Abstinence3m Set
Hide Arm/Group Description:
Enrolled subjects, who were abstinent from smoking from their actual quit date to Month 3, were included in the Abstinence3m set.
Overall Number of Participants Analyzed 720
Mean (95% Confidence Interval)
Unit of Measure: Percent of predicted FVC
Baseline Number Analyzed 674 participants
101
(99.7 to 101)
Month 6 Number Analyzed 437 participants
100
(99 to 101)
Month 12 Number Analyzed 334 participants
99.1
(97.8 to 100)
20.Primary Outcome
Title FVC Post-bronchodilator, Expressed as Percentage Predicted (FVC %Pred).
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Abstinence3m Set
Hide Arm/Group Description:
Enrolled subjects, who were abstinent from smoking from their actual quit date to Month 3, were included in the Abstinence3m set.
Overall Number of Participants Analyzed 720
Mean (95% Confidence Interval)
Unit of Measure: Percent of predicted FVC
Baseline Number Analyzed 673 participants
100
(99.1 to 101)
Month 6 Number Analyzed 437 participants
99.5
(98.3 to 101)
Month 12 Number Analyzed 334 participants
98.6
(97.3 to 99.9)
21.Primary Outcome
Title FEV1/FVC Pre-bronchodilator Expressed as a Ratio
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Abstinence3m Set
Hide Arm/Group Description:
Enrolled subjects, who were abstinent from smoking from their actual quit date to Month 3, were included in the Abstinence3m set.
Overall Number of Participants Analyzed 720
Mean (95% Confidence Interval)
Unit of Measure: ratio
Baseline Number Analyzed 674 participants
0.771
(0.766 to 0.776)
Month 6 Number Analyzed 437 participants
0.77
(0.764 to 0.776)
Month 12 Number Analyzed 334 participants
0.778
(0.772 to 0.785)
22.Primary Outcome
Title FEV1/FVC Post-bronchodilator Expressed as a Ratio
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Abstinence3m Set
Hide Arm/Group Description:
Enrolled subjects, who were abstinent from smoking from their actual quit date to Month 3, were included in the Abstinence3m set.
Overall Number of Participants Analyzed 720
Mean (95% Confidence Interval)
Unit of Measure: ratio
Baseline Number Analyzed 673 participants
0.796
(0.791 to 0.8)
Month 6 Number Analyzed 437 participants
0.797
(0.791 to 0.802)
Month 12 Number Analyzed 334 participants
0.803
(0.797 to 0.809)
23.Primary Outcome
Title FEF 25-75 Forced Expiratory Flow, Pre-bronchodilator, Expressed as Percentage Predicted (FEF 25-75 %Pred)
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Abstinence3m Set
Hide Arm/Group Description:
Enrolled subjects, who were abstinent from smoking from their actual quit date to Month 3, were included in the Abstinence3m set.
Overall Number of Participants Analyzed 720
Mean (95% Confidence Interval)
Unit of Measure: Percent of predicted FEF 25-75%
Baseline Number Analyzed 674 participants
84.8
(82.9 to 86.7)
Month 6 Number Analyzed 437 participants
84.2
(81.8 to 86.6)
Month 12 Number Analyzed 334 participants
86.6
(84 to 89.3)
24.Primary Outcome
Title FEF 25-75 Forced Expiratory Flow, Post-bronchodilator, Expressed as Percentage Predicted (FEF 25-75 %Pred)
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Abstinence3m Set
Hide Arm/Group Description:
Enrolled subjects, who were abstinent from smoking from their actual quit date to Month 3, were included in the Abstinence3m set.
Overall Number of Participants Analyzed 720
Mean (95% Confidence Interval)
Unit of Measure: Percent of predicted FEF 25-75%
Baseline Number Analyzed 673 participants
95.7
(93.7 to 97.7)
Month 6 Number Analyzed 437 participants
95.8
(93.9 to 98.3)
Month 12 Number Analyzed 334 participants
98.1
(95.4 to 101)
25.Primary Outcome
Title Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL).
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Abstinence3m Set
Hide Arm/Group Description:
Enrolled subjects, who were abstinent from smoking from their actual quit date to Month 3, were included in the Abstinence3m set.
Overall Number of Participants Analyzed 720
Geometric Mean (95% Confidence Interval)
Unit of Measure: pg/mg creat
Baseline (pg/mg creat) Number Analyzed 585 participants
125
(114 to 136)
Month 6 (pg/mg creat) Number Analyzed 443 participants
5.11
(4.68 to 5.58)
Month 12 (pg/mg creat) Number Analyzed 357 participants
4.37
(3.99 to 4.78)
Time Frame Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, for a duration of up to 66 weeks for each subject.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Enrolled Population
Hide Arm/Group Description The Enrolled Population included 1184 subjects enrolled from the screened population.
All-Cause Mortality
Enrolled Population
Affected / at Risk (%)
Total   1/1184 (0.08%)    
Hide Serious Adverse Events
Enrolled Population
Affected / at Risk (%) # Events
Total   17/1184 (1.44%)    
Cardiac disorders   
Atrial fibrilation * 1  1/1184 (0.08%)  1
Endocrine disorders   
Goitre * 1  1/1184 (0.08%)  1
Infections and infestations   
Pyelonephritis * 1  2/1184 (0.17%)  5
Pneumonia * 1  2/1184 (0.17%)  2
Urosepsis * 1  1/1184 (0.08%)  4
Clostridium difficile colitis * 1  1/1184 (0.08%)  1
Helicobacter gastritis * 1  1/1184 (0.08%)  1
Injury, poisoning and procedural complications   
Ankle fracture * 1  1/1184 (0.08%)  1
Cartilage injury * 1  1/1184 (0.08%)  1
Head injury * 1  1/1184 (0.08%)  1
Radius fracture * 1  1/1184 (0.08%)  1
Tendon rupture * 1  1/1184 (0.08%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Breast cancer * 1  1/1184 (0.08%)  1
Lung neoplasm malignant * 1  1/1184 (0.08%)  1
Osteoma * 1  1/1184 (0.08%)  1
Nervous system disorders   
Presyncope * 1  1/1184 (0.08%)  1
Ruptured cerebral aneurysm * 1  1/1184 (0.08%)  1
Renal and urinary disorders   
Nephrolithiasis * 1  1/1184 (0.08%)  1
1
Term from vocabulary, MedDRA (18.0)
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Enrolled Population
Affected / at Risk (%) # Events
Total   313/1184 (26.44%)    
Infections and infestations   
Nasopharyngitis * 1  158/1184 (13.34%)  213
Upper respiratory tract infection * 1  83/1184 (7.01%)  94
Investigations   
Weight increased * 1  72/1184 (6.08%)  74
1
Term from vocabulary, MedDRA (18.0)
*
Indicates events were collected by non-systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

We confirm we have the contractual provisions in place which specify that in no event will the study site be allowed to disclose to any third party (or publicly release) any information obtained through the study without the CRO's prior written consent which in turn cannot provide such consent without Sponsor's approval unless such publication is made to satisfy regulatory requirements.

The Intellectual Property rights and research results from the present study belong to the Sponsor.

Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Christelle Haziza, Director Health Science and Biostatistics
Organization: Philip Morris Products S.A.
Phone: +41 58 242 11 11
EMail: christelle.haziza@pmi.com
Publications of Results:
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.
Other Publications:
Layout table for additonal information
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 Submitted: April 14, 2015
First Posted: May 4, 2015
Results First Submitted: April 25, 2019
Results First Posted: August 26, 2019
Last Update Posted: January 30, 2023