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Chronic obstructive pulmonary disease (COPD) is a common inflammatory disease of the airway affecting approximately 10% of individuals aged 40 years or more with a smoking history. The disease is characterized by an increase in numbers of airway white blood cells (neutrophils, lymphocytes and monocytes). Stimulation of white blood cells results in the release of different agents of inflammation. Some of these agents give an indication of the presence or severity of a disease when measured.
This case control study will be conducted at The Heart Lung Centre, London, UK. The study aims to determine biomarkers for the differentiation of subjects with COPD (GOLD Stage 1-2 and who are current smokers with a ≥ 10 pack year smoking history) and three matched control groups: one of non-smoking subjects (never smoked), one of ex-smokers and one of current smokers. COPD subjects will be matched to the non-COPD subjects by gender, age and ethnicity.
The study will include a range of physiological measurements including lung function, computerized tomography scans (CT scans), cardio pulmonary exercise test and computerized multichannel lung sounds analysis (Stethographics). In addition, lung inflammation will be assessed by cellular and molecular biomarkers using e.g. transcriptomics and proteomics technologies.
At the screening visit, subject consent will be obtained prior to conducting any study related procedures. Informed consent may be obtained on registration/review visit at the Centre where it is conducted and thus prior to visit 1.
The screening visit will involve obtaining demographic data and medical history information as well as performing safety assessments such as vital sign measurements, electrocardiogram (ECG), and clinical laboratory tests. An induced sputum sample will be obtained to ensure that subjects can produce an adequate sputum sample. Smokers will receive information on smoking cessation at the screening visit and follow-up telephone call.
Subjects will come back to the center on up to four further occasions if they meet the inclusion/exclusion criteria at screening:
A follow-up telephone call will be conducted 3-10 days post visit 4.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: COPD GOLD Stage 1-2 | Subjects with a clinical diagnosis of COPD, according to the GOLD guidelines (Stages 1-2), who are current smokers with at least a 10 pack-year smoking history. | ||
| Group 2: Current Cigarette Smokers | Subjects who are current smokers with at least a 10 pack-year smoking history, and matched to the COPD cases by ethnicity, gender and age (within 5 years). | ||
| Group 3: Ex-Smokers | Subjects who are ex-smokers with at least a 10 pack-year smoking history who have not smoked for at least one year, and matched to the COPD cases by ethnicity, gender and age (within 5 years). | ||
| Group 4: Never Smokers | Subjects who have never smoked (non-smokers), and matched to the COPD cases by ethnicity, gender and age (within 5 years). |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Spirometry Measurement: Percentage of Predicted Forced Expiratory Volume in 1 Second (FEV1 %Pred) | Up to 59 days | |
| Gas Transfer: Percentage of Predicted Total Diffusing Capacity of the Lungs for Carbon Monoxide (TLCO %Pred) | Up to 59 days | |
| Impulse Oscillometry (IOS) Measurements: Percentage of Predicted Central Airway Resistance at 5Hz (R5 %Pred) | Up to 59 days | |
| Impulse Oscillometry (IOS) Measurements: Percentage of Predicted Reactance at 5 Hz (X5 % Pred) | Up to 59 days | |
| Impulse Oscillometry (IOS) Measurements: Resonant Frequency (Fres) | Up to 59 days | |
| Stethographics Measurements: Non-Weighted Acoustic Chronic Obstructive Pulmonary Disease Scores (ACOPDS) | Stethographics analysis was performed using the 16-channel lung sound analyzer system STG1602 (Stethographics, Boston, MA, USA) following the supplier's recommendations. Lung sound data are obtained from an intermediate deeper-than-normal breath (pattern 2; P2). Each breath pattern is recorded for a minimum of 30 seconds allowing 3 to 6 breaths to be taken, with measurements completed over 3 to 4 minutes. Each of the 16 parameters derived from one measurement are evaluated and a score from 0 to 10 is assigned based on the value of the individual parameter. The total standard Acoustic COPD Score (ACOPDS) is calculated as the sum of the individual score for each parameter, which permits a maximum score of 160. Although this stethographics analysis system was considered experimental, a higher score was associated with poor health outcomes and a lower score with a better health state. | Up to 59 days |
| Dyspnoea Assessment: Modified Medical Research Council (MMRC) Dyspnoea Scale |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Total Leukocytes and Differential Leukocytes Count in Sputum | Results are available at: Titz B, Sewer A, Schneider T, Elamin A, Martin F, Dijon S, Luettich K, Guedj E, Vuillaume G, Ivanov NV, Peck MJ, Chaudhary NI, Hoeng J, Peitsch MC. Alterations in the sputum proteome and transcriptome in smokers and early-stage COPD subjects. J Proteomics. 2015 Oct 14;128:306-20. doi: 10.1016/j.jprot.2015.08.009. Epub 2015 Aug 22. PMID: 26306861 |
Inclusion Criteria
Additional Inclusion Criteria COPD Group
Additional Inclusion Criteria Non-Smokers Group
Additional Inclusion Criteria Smokers Group
Additional Inclusion Criteria Ex-Smokers Group
Exclusion Criteria:
Additional Exclusion Criteria - subjects with COPD
Not provided
Not provided
In this study, male and female subjects aged between 40-70 years will be included. All subjects must be matched by ethnicity, gender and age (within 5 years) of the subjects with COPD recruited in the study.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Brian Leaker, MD | Heart Lung Centre, Queen Anne Street Medical Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart Lung Centre, Queen Anne Street Medical Centre | London | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26306861 | Result | Titz B, Sewer A, Schneider T, Elamin A, Martin F, Dijon S, Luettich K, Guedj E, Vuillaume G, Ivanov NV, Peck MJ, Chaudhary NI, Hoeng J, Peitsch MC. Alterations in the sputum proteome and transcriptome in smokers and early-stage COPD subjects. J Proteomics. 2015 Oct 14;128:306-20. doi: 10.1016/j.jprot.2015.08.009. Epub 2015 Aug 22. | |
| 26614807 |
| Label | URL |
|---|---|
| Sputum transcriptomics | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| Individual Participant Data Set | View IPD |
Data for transcriptomics (sputum and nasal scrapes) and proteomics (sputum) are published and available via the following links:
http://www.ebi.ac.uk/arrayexpress/experiments/E-MTAB-3604/
http://www.ebi.ac.uk/pride/archive/projects/PXD001977
http://www.ebi.ac.uk/arrayexpress/experiments/E-MTAB-4015/
The link to the Array Express database will be provided upon online publication
Not provided
Immediately following publication. No end date.
Anyone who wishes to access the data.
Not provided
Study initiated (first subject enrolled): 01 July 2011
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: COPD GOLD Stage 1-2 | Subjects with a clinical diagnosis of COPD, according to the GOLD guidelines (Stages 1-2), who are current smokers with at least a 10 pack-year smoking history. |
| FG001 | Group 2: Current Cigarette Smokers | Subjects who are current smokers with at least a 10 pack-year smoking history, and matched to the COPD cases by ethnicity, gender and age (within 5 years). |
| FG002 | Group 3: Ex-Smokers | Subjects who are ex-smokers with at least a 10 pack-year smoking history who have not smoked for at least one year, and matched to the COPD cases by ethnicity, gender and age (within 5 years). |
| FG003 | Group 4: Never Smokers | Subjects who have never smoked (non-smokers), and matched to the COPD cases by ethnicity, gender and age (within 5 years). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: COPD GOLD Stage 1-2 | Subjects with a clinical diagnosis of COPD, according to the GOLD guidelines (Stages 1-2), who are current smokers with at least a 10 pack-year smoking history. |
| BG001 | Group 2: Current Cigarette Smokers |
| 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 | Spirometry Measurement: Percentage of Predicted Forced Expiratory Volume in 1 Second (FEV1 %Pred) | Of the 252 enrolled subjects, 240 (60 per group) completed the study, and were included in the analysis population. | Posted | Mean | 95% Confidence Interval | percent of predicted FEV1 | Up to 59 days |
|
From the informed consent form until the end of the study.
The safety analysis was performed on the Study Population. As there was no investigational product, this was defined as all subjects who were enrolled into the study
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1: COPD GOLD Stage 1-2 | Subjects with a clinical diagnosis of COPD, according to the GOLD guidelines (Stages 1-2), who are current smokers with at least a 10 pack-year smoking history. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Influenza | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julia HOENG, PhD | Philip Morris Products S.A. | +41 (58) 242 2214 | clinicaltrials.pmi@pmi.com |
Not provided
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D000073865 | Cigarette Smoking |
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
Not provided
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Proteomic investigations: Induced Sputum
Transcriptomics investigations (mRNA and micro RNA): Whole Blood, Nasal Scrapes, Induced sputum cell pellet
Genomic DNA sequencing: Whole blood
Lipidomics: Whole blood
The MMRC scale uses a simple grading system to assess a subject's level of dyspnea (shortness of breath). Subjects were asked to grade the degree of breathlessness related to activities by choosing 1 of the following answers:
|
| Up to 59 days |
| Prediction of Mortality and Hospitalizations: Modified BODE Index (mBODE) | The BODE Index is a 10-point scale to assess prognostic factors in COPD patients. Body mass index ("B"), airway obstruction ("O"), dyspnea ("D"), and exercise tolerance ("E") are each graded on a 4 point scale (0 to 3), except body mass index (0 or 1) . The final BODE Index value is the sum of the scores for each prognostic factor, where a higher BODE score indicates a higher risk of death. The modified BODE (mBODE) index as defined by Lopez-Campos (2010) was used in this study, and is composed of the following factors:
Lopez-Campos, José Luis, et al. "Modified BODE indexes: Agreement between multidimensional prognostic systems based on oxygen uptake." International Journal of Chronic Obstructive Pulmonary Disease (2010): 133-140. | Up to 59 days |
| High-Resolution Computerised Tomography (HRCT) of the Chest | CT scans were assessed by two radiologists. A scoring system from 0 to 4 was applied, depending upon the component:
The total score (higher score indicated a poor outcome) was derived from the mean of all scores. This is described in Chaudhary, Nveed, et al. "Physiological and biological characterization of smokers with and without COPD." F1000Research 6 (2017). | Up to 59 days |
| Up to 59 days |
| Protein Markers as Determined by Proteomics Analysis of Induced Sputum | Results are available at: Titz B, Sewer A, Schneider T, Elamin A, Martin F, Dijon S, Luettich K, Guedj E, Vuillaume G, Ivanov NV, Peck MJ, Chaudhary NI, Hoeng J, Peitsch MC. Alterations in the sputum proteome and transcriptome in smokers and early-stage COPD subjects. J Proteomics. 2015 Oct 14;128:306-20. doi: 10.1016/j.jprot.2015.08.009. Epub 2015 Aug 22. PMID: 26306861 | Up to 59 days |
| Lipid Markers as Determined by Lipidomic Analysis of Blood Samples | Reference to be provided upon publication. | Up to 59 days |
| mRNA and miRNA (Transcriptomics) Derived From Induced Sputum | Results are available at: Titz B, Sewer A, Schneider T, Elamin A, Martin F, Dijon S, Luettich K, Guedj E, Vuillaume G, Ivanov NV, Peck MJ, Chaudhary NI, Hoeng J, Peitsch MC. Alterations in the sputum proteome and transcriptome in smokers and early-stage COPD subjects. J Proteomics. 2015 Oct 14;128:306-20. doi: 10.1016/j.jprot.2015.08.009. Epub 2015 Aug 22. PMID: 26306861 | Up to 59 days |
| mRNA and miRNA (Transcriptomics) Derived From Leukocytes Obtained From Blood Samples | Results are available at: Martin F, Talikka M, Hoeng J, Peitsch MC. Identification of gene expression signature for cigarette smoke exposure response--from man to mouse. Hum Exp Toxicol. 2015 Dec;34(12):1200-11. doi: 10.1177/0960327115600364 PMID: 26614807 | Up to 59 days |
| mRNA and miRNA (Transcriptomics) Derived From Nasal Epithelial Cells Obtained by Nasal Scrapes | Reference to be provided upon publication. | Up to 59 days |
| Martin F, Talikka M, Hoeng J, Peitsch MC. Identification of gene expression signature for cigarette smoke exposure response--from man to mouse. Hum Exp Toxicol. 2015 Dec;34(12):1200-11. doi: 10.1177/0960327115600364. |
| 29862011 | Result | Chaudhary N, Luettich K, Peck MJ, Pierri E, Felber-Medlin L, Vuillaume G, Leroy P, Hoeng J, Peitsch MC. Physiological and biological characterization of smokers with and without COPD. F1000Res. 2017 Jun 13;6:877. doi: 10.12688/f1000research.11698.2. eCollection 2017. |
| 27657052 | Derived | Titz B, Luettich K, Leroy P, Boue S, Vuillaume G, Vihervaara T, Ekroos K, Martin F, Peitsch MC, Hoeng J. Alterations in Serum Polyunsaturated Fatty Acids and Eicosanoids in Patients with Mild to Moderate Chronic Obstructive Pulmonary Disease (COPD). Int J Mol Sci. 2016 Sep 20;17(9):1583. doi: 10.3390/ijms17091583. |
| Sputum proteomics | View source |
| Nasal scrapes transcriptomics | View source |
| Subject not matched |
|
| Adverse Event |
|
Subjects who are current smokers with at least a 10 pack-year smoking history, and matched to the COPD cases by ethnicity, gender and age (within 5 years). |
| BG002 | Group 3: Ex-Smokers | Subjects who are ex-smokers with at least a 10 pack-year smoking history who have not smoked for at least one year, and matched to the COPD cases by ethnicity, gender and age (within 5 years). |
| BG003 | Group 4: Never Smokers | Subjects who have never smoked (non-smokers), and matched to the COPD cases by ethnicity, gender and age (within 5 years). |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Number of Cigarettes Smoked Per Day | Mean | Standard Deviation | Cig/day |
|
| Pack-year | Mean | Standard Deviation | Pack-year |
|
| Weekly Consumption of Alcohol | The weekly consumption of alcohol is expressed in "Units of alcohol". Units of alcohol are used as a measure to quantify the actual alcoholic content within a given volume of an alcoholic beverage, in order to provide guidance on total alcohol consumption. One unit of alcohol is defined as 10 milliliters (8 grams) of pure alcohol. At the time this study was planned and conducted, the recommended units of alcohol not to be exceeded per week were 28 units for males and 21 units for females. | Mean | Standard Deviation | Units of alcohol |
|
| OG002 | Group 3: Ex-Smokers | Subjects who are ex-smokers with at least a 10 pack-year smoking history who have not smoked for at least one year, and matched to the COPD cases by ethnicity, gender and age (within 5 years). |
| OG003 | Group 4: Never Smokers | Subjects who have never smoked (non-smokers), and matched to the COPD cases by ethnicity, gender and age (within 5 years). |
|
|
|
| Primary | Gas Transfer: Percentage of Predicted Total Diffusing Capacity of the Lungs for Carbon Monoxide (TLCO %Pred) | Of the 252 enrolled subjects, 240 (60 per group) completed the study, and were included in the analysis population. | Posted | Mean | 95% Confidence Interval | percent predicted TLCO | Up to 59 days |
|
|
|
|
| Primary | Impulse Oscillometry (IOS) Measurements: Percentage of Predicted Central Airway Resistance at 5Hz (R5 %Pred) | Of the 252 enrolled subjects, 240 (60 per group) completed the study, and were included in the analysis population. | Posted | Mean | 95% Confidence Interval | percent predicted R5 | Up to 59 days |
|
|
|
|
| Primary | Impulse Oscillometry (IOS) Measurements: Percentage of Predicted Reactance at 5 Hz (X5 % Pred) | Of the 252 enrolled subjects, 240 (60 per group) completed the study, and were included in the analysis population. | Posted | Mean | 95% Confidence Interval | percent predicted X5 | Up to 59 days |
|
|
|
|
| Primary | Impulse Oscillometry (IOS) Measurements: Resonant Frequency (Fres) | Of the 252 enrolled subjects, 240 (60 per group) completed the study, and were included in the analysis population. | Posted | Mean | 95% Confidence Interval | Hz | Up to 59 days |
|
|
|
|
| Primary | Stethographics Measurements: Non-Weighted Acoustic Chronic Obstructive Pulmonary Disease Scores (ACOPDS) | Stethographics analysis was performed using the 16-channel lung sound analyzer system STG1602 (Stethographics, Boston, MA, USA) following the supplier's recommendations. Lung sound data are obtained from an intermediate deeper-than-normal breath (pattern 2; P2). Each breath pattern is recorded for a minimum of 30 seconds allowing 3 to 6 breaths to be taken, with measurements completed over 3 to 4 minutes. Each of the 16 parameters derived from one measurement are evaluated and a score from 0 to 10 is assigned based on the value of the individual parameter. The total standard Acoustic COPD Score (ACOPDS) is calculated as the sum of the individual score for each parameter, which permits a maximum score of 160. Although this stethographics analysis system was considered experimental, a higher score was associated with poor health outcomes and a lower score with a better health state. | Of the 252 enrolled subjects, 240 (60 per group) completed the study, and were included in the analysis population. | Posted | Mean | 95% Confidence Interval | score on a scale | Up to 59 days |
|
|
|
|
| Primary | Dyspnoea Assessment: Modified Medical Research Council (MMRC) Dyspnoea Scale | The MMRC scale uses a simple grading system to assess a subject's level of dyspnea (shortness of breath). Subjects were asked to grade the degree of breathlessness related to activities by choosing 1 of the following answers:
| Of the 252 enrolled subjects, 240 completed the study, but 235 were included in the analysis population as data were missing for 5 subjects:
| Posted | Mean | 95% Confidence Interval | units on a scale | Up to 59 days |
|
|
|
|
| Primary | Prediction of Mortality and Hospitalizations: Modified BODE Index (mBODE) | The BODE Index is a 10-point scale to assess prognostic factors in COPD patients. Body mass index ("B"), airway obstruction ("O"), dyspnea ("D"), and exercise tolerance ("E") are each graded on a 4 point scale (0 to 3), except body mass index (0 or 1) . The final BODE Index value is the sum of the scores for each prognostic factor, where a higher BODE score indicates a higher risk of death. The modified BODE (mBODE) index as defined by Lopez-Campos (2010) was used in this study, and is composed of the following factors:
Lopez-Campos, José Luis, et al. "Modified BODE indexes: Agreement between multidimensional prognostic systems based on oxygen uptake." International Journal of Chronic Obstructive Pulmonary Disease (2010): 133-140. | Of the 252 enrolled subjects, 240 completed the study, but 233 were included in the analysis population as data were missing for 7 subjects:
| Posted | Mean | 95% Confidence Interval | score on a scale | Up to 59 days |
|
|
|
|
| Primary | High-Resolution Computerised Tomography (HRCT) of the Chest | CT scans were assessed by two radiologists. A scoring system from 0 to 4 was applied, depending upon the component:
The total score (higher score indicated a poor outcome) was derived from the mean of all scores. This is described in Chaudhary, Nveed, et al. "Physiological and biological characterization of smokers with and without COPD." F1000Research 6 (2017). | Of the 252 enrolled subjects, 240 (60 per group) completed the study, and were included in the analysis population. | Posted | Mean | 95% Confidence Interval | score on a scale | Up to 59 days |
|
|
|
|
| Other Pre-specified | Total Leukocytes and Differential Leukocytes Count in Sputum | Results are available at: Titz B, Sewer A, Schneider T, Elamin A, Martin F, Dijon S, Luettich K, Guedj E, Vuillaume G, Ivanov NV, Peck MJ, Chaudhary NI, Hoeng J, Peitsch MC. Alterations in the sputum proteome and transcriptome in smokers and early-stage COPD subjects. J Proteomics. 2015 Oct 14;128:306-20. doi: 10.1016/j.jprot.2015.08.009. Epub 2015 Aug 22. PMID: 26306861 | Not Posted | Up to 59 days | Participants |
| Other Pre-specified | Protein Markers as Determined by Proteomics Analysis of Induced Sputum | Results are available at: Titz B, Sewer A, Schneider T, Elamin A, Martin F, Dijon S, Luettich K, Guedj E, Vuillaume G, Ivanov NV, Peck MJ, Chaudhary NI, Hoeng J, Peitsch MC. Alterations in the sputum proteome and transcriptome in smokers and early-stage COPD subjects. J Proteomics. 2015 Oct 14;128:306-20. doi: 10.1016/j.jprot.2015.08.009. Epub 2015 Aug 22. PMID: 26306861 | Not Posted | Up to 59 days | Participants |
| Other Pre-specified | Lipid Markers as Determined by Lipidomic Analysis of Blood Samples | Reference to be provided upon publication. | Not Posted | Up to 59 days | Participants |
| Other Pre-specified | mRNA and miRNA (Transcriptomics) Derived From Induced Sputum | Results are available at: Titz B, Sewer A, Schneider T, Elamin A, Martin F, Dijon S, Luettich K, Guedj E, Vuillaume G, Ivanov NV, Peck MJ, Chaudhary NI, Hoeng J, Peitsch MC. Alterations in the sputum proteome and transcriptome in smokers and early-stage COPD subjects. J Proteomics. 2015 Oct 14;128:306-20. doi: 10.1016/j.jprot.2015.08.009. Epub 2015 Aug 22. PMID: 26306861 | Not Posted | Up to 59 days | Participants |
| Other Pre-specified | mRNA and miRNA (Transcriptomics) Derived From Leukocytes Obtained From Blood Samples | Results are available at: Martin F, Talikka M, Hoeng J, Peitsch MC. Identification of gene expression signature for cigarette smoke exposure response--from man to mouse. Hum Exp Toxicol. 2015 Dec;34(12):1200-11. doi: 10.1177/0960327115600364 PMID: 26614807 | Not Posted | Up to 59 days | Participants |
| Other Pre-specified | mRNA and miRNA (Transcriptomics) Derived From Nasal Epithelial Cells Obtained by Nasal Scrapes | Reference to be provided upon publication. | Not Posted | Up to 59 days | Participants |
| 0 |
| 62 |
| 42 |
| 62 |
| EG001 | Group 2: Current Cigarette Smokers | Subjects who are current smokers with at least a 10 pack-year smoking history, and matched to the COPD cases by ethnicity, gender and age (within 5 years). | 0 | 65 | 51 | 65 |
| EG002 | Group 3: Ex-Smokers | Subjects who are ex-smokers with at least a 10 pack-year smoking history who have not smoked for at least one year, and matched to the COPD cases by ethnicity, gender and age (within 5 years). | 0 | 64 | 35 | 64 |
| EG003 | Group 4: Never Smokers | Subjects who have never smoked (non-smokers), and matched to the COPD cases by ethnicity, gender and age (within 5 years). | 0 | 61 | 40 | 61 |
| Nasopharyngitis | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Computerised tomogram abnormal | Investigations | MedDRA (14.1) | Non-systematic Assessment |
|
| Liver scan abnormal | Investigations | MedDRA (14.1) | Non-systematic Assessment |
|
| Pulmonary function challenge test abnormal | Investigations | MedDRA (14.1) | Non-systematic Assessment |
|
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Bronchial wall thickening | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
We confirm we have the contractual provisions in place which specifies 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 belongs to the Sponsor.
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000073869 | Tobacco Smoking |
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| t-test, 2 sided |
Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity). |
| <0.0001 |
| Mean Difference (Final Values) |
| -24.553 |
| 2-Sided |
| 95 |
| -29.501 |
| -19.604 |
Difference Group 1 (COPD) - Group 3 (Ex-smokers) |
| Superiority or Other (legacy) |
| t-test, 2 sided | Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity). | <0.0001 | Mean Difference (Final Values) | -14.107 | 2-Sided | 95 | -19.043 | -9.170 | Difference Group 1 (COPD) - Group 2 (Current cigarette smokers) | Superiority or Other (legacy) |
| t-test, 2 sided | Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity). | 0.0983 | Mean Difference (Final Values) | -3.058 | 2-Sided | 95 | -6.702 | 0.585 | Difference Group 3 (Ex-smokers) - Group 4 (Never smokers) | Superiority or Other (legacy) |
| t-test, 2 sided | Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity). | <0.0001 | Mean Difference (Final Values) | -10.446 | 2-Sided | 95 | -13.845 | -7.047 | Difference Group 2 (Current cigarette smokers) - Group 3 (Ex-smokers) | Superiority or Other (legacy) |
| t-test, 2 sided | Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity). | <0.0001 | Mean Difference (Final Values) | -13.504 | 2-Sided | 95 | -17.302 | -9.707 | Difference Group 2 (Current cigarette smokers) - Group 4 (Never smokers) | Superiority or Other (legacy) |
| t-test, 2 sided |
Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity). |
| <0.0001 |
| Mean Difference (Final Values) |
| 26.538 |
| 2-Sided |
| 95 |
| 14.890 |
| 38.185 |
Difference Group 1 (COPD) - Group 3 (Ex-smokers) |
| Superiority or Other (legacy) |
| t-test, 2 sided | Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity). | 0.0018 | Mean Difference (Final Values) | 20.661 | 2-Sided | 95 | 7.997 | 33.324 | Difference Group 1 (COPD) - Group 2 (Current cigarette smokers) | Superiority or Other (legacy) |
| t-test, 2 sided | Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity). | 0.0015 | Mean Difference (Final Values) | 13.910 | 2-Sided | 95 | 5.534 | 22.286 | Difference Group 3 (Ex-smokers) - Group 4 (Never smokers) | Superiority or Other (legacy) |
| t-test, 2 sided | Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity). | 0.1847 | Mean Difference (Final Values) | 5.877 | 2-Sided | 95 | -2.886 | 14.639 | Difference Group 2 (Current cigarette smokers) - Group 3 (Ex-smokers) | Superiority or Other (legacy) |
| t-test, 2 sided | Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity). | 0.0003 | Mean Difference (Final Values) | 19.787 | 2-Sided | 95 | 9.536 | 30.038 | Difference Group 2 (Current cigarette smokers) - Group 4 (Never smokers) | Superiority or Other (legacy) |
| t-test, 2 sided |
Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity). |
| 0.1956 |
| Mean Difference (Final Values) |
| 2317.131 |
| 2-Sided |
| 95 |
| -1224.786 |
| 5859.048 |
Difference Group 1 (COPD) - Group 3 (Ex-smokers) |
| Superiority or Other (legacy) |
| t-test, 2 sided | Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity). | 0.2077 | Mean Difference (Final Values) | 2396.589 | 2-Sided | 95 | -1367.692 | 6160.870 | Difference Group 1 (COPD) - Group 2 (Current cigarette smokers) | Superiority or Other (legacy) |
| t-test, 2 sided | Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity). | 0.1154 | Mean Difference (Final Values) | -5296.856 | 2-Sided | 95 | -11930.190 | 1336.478 | Difference Group 3 (Ex-smokers) - Group 4 (Never smokers) | Superiority or Other (legacy) |
| t-test, 2 sided | Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity). | 0.8095 | Mean Difference (Final Values) | -79.458 | 2-Sided | 95 | -736.151 | 577.234 | Difference Group 2 (Current cigarette smokers) - Group 3 (Ex-smokers) | Superiority or Other (legacy) |
| t-test, 2 sided | Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity). | 0.1113 | Mean Difference (Final Values) | -5376.314 | 2-Sided | 95 | -12030.714 | 1278.085 | Difference Group 2 (Current cigarette smokers) - Group 4 (Never smokers) | Superiority or Other (legacy) |
| t-test, 2 sided |
Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity). |
| <0.0001 |
| Mean Difference (Final Values) |
| 4.845 |
| 2-Sided |
| 95 |
| 3.379 |
| 6.310 |
Difference Group 1 (COPD) - Group 3 (Ex-smokers) |
| Superiority or Other (legacy) |
| t-test, 2 sided | Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity). | <0.0001 | Mean Difference (Final Values) | 3.454 | 2-Sided | 95 | 1.923 | 4.984 | Difference Group 1 (COPD) - Group 2 (Current cigarette smokers) | Superiority or Other (legacy) |
| t-test, 2 sided | Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity). | 0.0418 | Mean Difference (Final Values) | 1.171 | 2-Sided | 95 | 0.045 | 2.296 | Difference Group 3 (Ex-smokers) - Group 4 (Never smokers) | Superiority or Other (legacy) |
| t-test, 2 sided | Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity). | 0.0357 | Mean Difference (Final Values) | 1.391 | 2-Sided | 95 | 0.096 | 2.686 | Difference Group 2 (Current cigarette smokers) - Group 3 (Ex-smokers) | Superiority or Other (legacy) |
| t-test, 2 sided | Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity). | 0.0001 | Mean Difference (Final Values) | 2.562 | 2-Sided | 95 | 1.303 | 3.820 | Difference Group 2 (Current cigarette smokers) - Group 4 (Never smokers) | Superiority or Other (legacy) |
| t-test, 2 sided |
Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity). |
| <0.0001 |
| Mean Difference (Final Values) |
| 35.792 |
| 2-Sided |
| 95 |
| 29.761 |
| 41.822 |
Difference Group 1 (COPD) - Group 3 (Ex-smokers) |
| Superiority or Other (legacy) |
| t-test, 2 sided | Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity). | <0.0001 | Mean Difference (Final Values) | 29.167 | 2-Sided | 95 | 23.445 | 34.888 | Difference Group 1 (COPD) - Group 2 (Current cigarette smokers) | Superiority or Other (legacy) |
| t-test, 2 sided | Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity). | 0.0418 | Mean Difference (Final Values) | 3.842 | 2-Sided | 95 | 0.147 | 7.536 | Difference Group 3 (Ex-smokers) - Group 4 (Never smokers) | Superiority or Other (legacy) |
| t-test, 2 sided | Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity). | 0.0084 | Mean Difference (Final Values) | 6.625 | 2-Sided | 95 | 1.763 | 11.487 | Difference Group 2 (Current cigarette smokers) - Group 3 (Ex-smokers) | Superiority or Other (legacy) |
| t-test, 2 sided | Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity). | <0.0001 | Mean Difference (Final Values) | 10.467 | 2-Sided | 95 | 5.888 | 15.045 | Difference Group 2 (Current cigarette smokers) - Group 4 (Never smokers) | Superiority or Other (legacy) |
| t-test, 2 sided |
Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity). |
| <0.0001 |
| Mean Difference (Final Values) |
| 0.875 |
| 2-Sided |
| 95 |
| 0.609 |
| 1.141 |
Difference Group 1 (COPD) - Group 3 (Ex-smokers) |
| Superiority or Other (legacy) |
| t-test, 2 sided | Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity). | <0.0001 | Mean Difference (Final Values) | 0.649 | 2-Sided | 95 | 0.386 | 0.912 | Difference Group 1 (COPD) - Group 2 (Current cigarette smokers) | Superiority or Other (legacy) |
| t-test, 2 sided | Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity). | 0.3985 | Mean Difference (Final Values) | 0.069 | 2-Sided | 95 | -0.093 | 0.231 | Difference Group 3 (Ex-smokers) - Group 4 (Never smokers) | Superiority or Other (legacy) |
| t-test, 2 sided | Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity). | 0.0267 | Mean Difference (Final Values) | 0.220 | 2-Sided | 95 | 0.026 | 0.414 | Difference Group 2 (Current cigarette smokers) - Group 3 (Ex-smokers) | Superiority or Other (legacy) |
| t-test, 2 sided | Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity). | 0.0036 | Mean Difference (Final Values) | 0.305 | 2-Sided | 95 | 0.104 | 0.506 | Difference Group 2 (Current cigarette smokers) - Group 4 (Never smokers) | Superiority or Other (legacy) |
| t-test, 2 sided |
Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity). |
| <0.0001 |
| Mean Difference (Final Values) |
| 1.291 |
| 2-Sided |
| 95 |
| 0.924 |
| 1.658 |
Difference Group 1 (COPD) - Group 3 (Ex-smokers) |
| Superiority or Other (legacy) |
| t-test, 2 sided | Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity). | <0.0001 | Mean Difference (Final Values) | 1.073 | 2-Sided | 95 | 0.724 | 1.421 | Difference Group 1 (COPD) - Group 2 (Current cigarette smokers) | Superiority or Other (legacy) |
| t-test, 2 sided | Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity). | 0.0282 | Mean Difference (Final Values) | 0.276 | 2-Sided | 95 | 0.031 | 0.521 | Difference Group 3 (Ex-smokers) - Group 4 (Never smokers) | Superiority or Other (legacy) |
| t-test, 2 sided | Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity). | 0.1223 | Mean Difference (Final Values) | 0.207 | 2-Sided | 95 | -0.057 | 0.471 | Difference Group 2 (Current cigarette smokers) - Group 3 (Ex-smokers) | Superiority or Other (legacy) |
| t-test, 2 sided | Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity). | <0.0001 | Mean Difference (Final Values) | 0.492 | 2-Sided | 95 | 0.273 | 0.710 | Difference Group 2 (Current cigarette smokers) - Group 4 (Never smokers) | Superiority or Other (legacy) |
| t-test, 2 sided |
Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity). |
| <0.0001 |
| Mean Difference (Final Values) |
| 0.256 |
| 2-Sided |
| 95 |
| 0.158 |
| 0.354 |
Difference Group 1 (COPD) - Group 3 (Ex-smokers) |
| Superiority or Other (legacy) |
| t-test, 2 sided | Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity). | 0.0199 | Mean Difference (Final Values) | 0.136 | 2-Sided | 95 | 0.022 | 0.249 | Difference Group 1 (COPD) - Group 2 (Current cigarette smokers) | Superiority or Other (legacy) |
| t-test, 2 sided | Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity). | 0.0247 | Mean Difference (Final Values) | 0.117 | 2-Sided | 95 | 0.015 | 0.218 | Difference Group 3 (Ex-smokers) - Group 4 (Never smokers) | Superiority or Other (legacy) |
| t-test, 2 sided | Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity). | 0.0204 | Mean Difference (Final Values) | 0.120 | 2-Sided | 95 | 0.019 | 0.221 | Difference Group 2 (Current cigarette smokers) - Group 3 (Ex-smokers) | Superiority or Other (legacy) |
| t-test, 2 sided | Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity). | <0.0001 | Mean Difference (Final Values) | 0.237 | 2-Sided | 95 | 0.127 | 0.347 | Difference Group 2 (Current cigarette smokers) - Group 4 (Never smokers) | Superiority or Other (legacy) |