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| ID | Type | Description | Link |
|---|---|---|---|
| SA-SCR-01 | Other Identifier | Philip Morris Products S.A. |
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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).
This was a 12 month, multi-region, multi-center, ambulatory study conducted in the US, Japan and Europe. Smokers who were willing to quit smoking within the next 30 days at the Screening Visit were enrolled to reach approximately 950 subjects continuously abstinent from smoking from Actual Quit Date (AQD) onwards at week 2, in order to achieve at least 190 successful quitters expected to complete the study. Once approximately 950 subjects reached week 2, screening and enrollment were stopped.
Compliance with smoking abstinence was verified by self-reporting, CO breath tests, and urine cotinine tests. Smokers who were not continuously abstinent from smoking [i.e., free from tobacco product use (e.g., CC, pipes, cigars, snus) or any nicotine-containing product (including electronic cigarettes) other than nicotine replacement therapy (NRT)] from their AQD onwards were discontinued from the study. At the end of the study, 358 subjects were verified as continuously abstinent from their AQD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| High Density Lipoprotein C (HDL-C). | Concentrations of HDL-C measured in serum. Mean values are provided as descriptive statistics. | 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. | Baseline; 6 month; 12 month |
| Apo A1 | Concentrations of Apolipoprotein A1 measured in serum. Mean values are provided as descriptive statistics. | Baseline; 6 month; 12 month |
| Apo B | Concentrations of Apolipoprotein B measured in serum. Mean values are provided as descriptive statistics. | Baseline; 6 month; 12 month |
| White Blood Cells (WBC). | Concentrations of WBC measured in blood. Mean values are provided as descriptive statistics. | 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. | Baseline; 6 month; 12 month |
| Homocysteine | Concentrations of Homocysteine measured in plasma. Geometric mean values are provided as descriptive statistics. | Baseline; 6 month; 12 month |
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Inclusion Criteria:
Exclusion Criteria:
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Adult, smoking subjects willing to quit smoking with no restriction on race and ethnicities will be enrolled in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Christelle Haziza, PhD | Philip Morris Products S.A. | Study Chair |
| Christel Contzen, MD | Synexus Clinical Research GmbH | Principal Investigator |
| Monika Tomaszewska-Kiecana, MD | BioVirtus Research Site Sp. z o.o. | Principal Investigator |
| Susannah Eyre, MD | Synexus, Merseyside Clinical Research Centre | Principal Investigator |
| Jed Rose, PhD | Rose Research Center | Principal Investigator |
| Koichi Nakamura, MD | Clinical Research Tokyo Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rose Research Center | Charlotte | North Carolina | 28262 | United States | ||
| Synexus Clinical Research GmbH |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31199335 | Background | 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. | |
| Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Abstinence3m Set | Enrolled subjects, who were abstinent from smoking from their actual quit date to at least Month 3, were included in the Abstinence3m set. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Month 3 Visit |
| |||||||||||||
| Month 6 Visit |
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| Month 12 Visit |
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All Regions
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | High Density Lipoprotein C (HDL-C). | Concentrations of HDL-C measured in serum. Mean values are provided as descriptive statistics. | 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. | Posted | Mean | 95% Confidence Interval | mg/dL | Baseline; 6 month; 12 month |
|
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Enrolled Population | The Enrolled Population included 1184 subjects enrolled from the screened population. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyelonephritis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christelle Haziza, Director Health Science and Biostatistics | Philip Morris Products S.A. | +41 58 242 11 11 | christelle.haziza@pmi.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 18, 2017 | Apr 25, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 27, 2018 | Apr 25, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000073865 | Cigarette Smoking |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
| D015438 |
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Blood and urine bio-banking samples
| Fibrinogen | Concentrations of Fibrinogen measured in plasma. Geometric mean values are provided as descriptive statistics. | Baseline; 6 month; 12 month |
| Platelets | Concentrations of Platelets measured in plasma. Geometric mean values are provided as descriptive statistics. | 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. | 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. | Baseline; 6 month; 12 month |
| MPO | Concentrations of Myeloperoxidase measured in serum. Geometric mean values are provided as descriptive statistics. | 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. | 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. | 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. | Baseline; 6 month; 12 month |
| HbA1c | Glycosylated hemoglobin (HbA1c) is assayed from whole blood. Geometric means are provided as descriptive statistics. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline; 6 month; 12 month |
| Frankfurt am Main |
| Hesse |
| 60596 |
| Germany |
| Clinical Research Tokyo Hospital | Tokyo | 162-0053 | Japan |
| BioVirtus Research Site Sp. z o.o. | Kajetany | 05-830 | Poland |
| Synexus, Merseyside Clinical Research Centre | Liverpool | L22 0LG | United Kingdom |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| Height | Mean | Standard Deviation | cm |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Participants |
|
|
| Primary | Low-density Lipoprotein Cholesterol (LDL-C) | Concentrations of LDL-C measured in serum. Mean values are provided as descriptive statistics. | 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. | Posted | Mean | 95% Confidence Interval | mg/dL | Baseline; 6 month; 12 month |
|
|
|
| Primary | Apo A1 | Concentrations of Apolipoprotein A1 measured in serum. Mean values are provided as descriptive statistics. | 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. | Posted | Mean | 95% Confidence Interval | mg/dL | Baseline; 6 month; 12 month |
|
|
|
| Primary | Apo B | Concentrations of Apolipoprotein B measured in serum. Mean values are provided as descriptive statistics. | 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. | Posted | Mean | 95% Confidence Interval | mg/dL | Baseline; 6 month; 12 month |
|
|
|
| Primary | White Blood Cells (WBC). | Concentrations of WBC measured in blood. Mean values are provided as descriptive statistics. | 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. | Posted | Mean | 95% Confidence Interval | GI/L | Baseline; 6 month; 12 month |
|
|
|
| Primary | Hs-CRP | Concentrations of high sensitivity C-reactive protein (hs-CRP) measured in serum. Geometric mean values are provided as descriptive statistics. | 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. | Posted | Geometric Mean | 95% Confidence Interval | mg/L | Baseline; 6 month; 12 month |
|
|
|
| Primary | Homocysteine | Concentrations of Homocysteine measured in plasma. Geometric mean values are provided as descriptive statistics. | 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. | Posted | Geometric Mean | 95% Confidence Interval | μmol/L | Baseline; 6 month; 12 month |
|
|
|
| Primary | Fibrinogen | Concentrations of Fibrinogen measured in plasma. Geometric mean values are provided as descriptive statistics. | 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. | Posted | Geometric Mean | 95% Confidence Interval | mg/dL | Baseline; 6 month; 12 month |
|
|
|
| Primary | Platelets | Concentrations of Platelets measured in plasma. Geometric mean values are provided as descriptive statistics. | 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. | Posted | Geometric Mean | 95% Confidence Interval | GI/L | Baseline; 6 month; 12 month |
|
|
|
| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | pg/mg creat | Baseline; 6 month; 12 month |
|
|
|
| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | pg/mg creat | Baseline; 6 month; 12 month |
|
|
|
| Primary | MPO | Concentrations of Myeloperoxidase measured in serum. Geometric mean values are provided as descriptive statistics. | 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. | Posted | Geometric Mean | 95% Confidence Interval | μg/L | Baseline; 6 month; 12 month |
|
|
|
| Primary | Soluble Intercellular Adhesion Molecule 1 (sICAM-1). | Concentrations of sICAM-1 measured in serum. Geometric mean values are provided as descriptive statistics. | 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. | Posted | Geometric Mean | 95% Confidence Interval | ng/mL | Baseline; 6 month; 12 month |
|
|
|
| Primary | Albumin | Concentrations of Albumin measured in urine and expressed as concentration adjusted for creatinine. Geometric mean values are provided as descriptive statistics. | 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. | Posted | Geometric Mean | 95% Confidence Interval | mg/g creat | Baseline; 6 month; 12 month |
|
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|
| Primary | Carboxyhemoglobin (COHb). | Carboxyhemoglobin (COHb) is assayed from whole blood. Expressed as % of saturation of hemoglobin. Geometric means are provided as descriptive statistics. | 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. | Posted | Geometric Mean | 95% Confidence Interval | percentage | Baseline; 6 month; 12 month |
|
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|
| Primary | HbA1c | Glycosylated hemoglobin (HbA1c) is assayed from whole blood. Geometric means are provided as descriptive statistics. | 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. | Posted | Mean | 95% Confidence Interval | percentage of glycated hemoglobin | Baseline; 6 month; 12 month |
|
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|
| 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. | 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. | Posted | Mean | 95% Confidence Interval | Percent of predicted FEV1 | Baseline; 6 month; 12 month |
|
|
|
| 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. | 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. | Posted | Mean | 95% Confidence Interval | Percent of predicted FEV1 | Baseline; 6 month; 12 month |
|
|
|
| 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. | 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. | Posted | Mean | 95% Confidence Interval | Percent of predicted FVC | Baseline; 6 month; 12 month |
|
|
|
| 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. | 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. | Posted | Mean | 95% Confidence Interval | Percent of predicted FVC | Baseline; 6 month; 12 month |
|
|
|
| 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. | 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. | Posted | Mean | 95% Confidence Interval | ratio | Baseline; 6 month; 12 month |
|
|
|
| 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. | 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. | Posted | Mean | 95% Confidence Interval | ratio | Baseline; 6 month; 12 month |
|
|
|
| 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. | 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. | Posted | Mean | 95% Confidence Interval | Percent of predicted FEF 25-75% | Baseline; 6 month; 12 month |
|
|
|
| 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. | 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. | Posted | Mean | 95% Confidence Interval | Percent of predicted FEF 25-75% | Baseline; 6 month; 12 month |
|
|
|
| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | pg/mg creat | Baseline; 6 month; 12 month |
|
|
|
| 1 |
| 1,184 |
| 17 |
| 1,184 |
| 313 |
| 1,184 |
| Pneumonia | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Clostridium difficile colitis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Helicobacter gastritis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
|
| Cartilage injury | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
|
| Radius fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
|
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
|
| Osteoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Ruptured cerebral aneurysm | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
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| Atrial fibrilation | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
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| Goitre | Endocrine disorders | MedDRA (18.0) | Non-systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA (18.0) | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
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| Weight increased | Investigations | MedDRA (18.0) | Non-systematic Assessment |
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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.
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