COPDNCT01780298
Chronic Obstructive Pulmonary Disease (COPD) Biomarker Identification Study
An observational study of COPD, run by Philip Morris Products S.A. at 1 site in United Kingdom.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- COPD
- How many people
- 252 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2011to Dec 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- Provision of signed written informed consent which includes genetic consent.
- Ability to comply with study procedures.
- Males and females aged 40-70 years inclusive.
- Have a body mass index (BMI) between 18 and 35 kg/m2 inclusive and minimum body weights of 50 kg.
- Have a normal physical examination, and have normal laboratory values, 12-lead ECG and vital signs (blood pressure, heart rate and respiratory rate), unless the Investigator considers an abnormality as not clinically significant.
- Ability to perform reproducible spirometry according to the American Thoracic Society and the European Respiratory Society (ATS/ERS) guidelines (American Thoracic Society, 2005).
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- Ability to produce a minimum 0.1 gram sputum sample after induction with inhaled hypertonic saline.
- Additional Inclusion Criteria COPD Group
- A clinical diagnosis of COPD according to the GOLD guidelines (stage 1-2).
- Current smokers with ≥10 pack-year smoking history.
- Demonstrate a post-bronchodilator ratio between forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) of <70 % and FEV1 ≥50 % of predicted normal.
- Additional Inclusion Criteria Non-Smokers Group
- Have never smoked tobacco products.
- Demonstrate normal lung function by post bronchodilator FEV1 ≥80 % of predicted normal, with no evidence of airway obstruction FEV1/FVC ratio ≥70 %.
- Have a sputum eosinophilia <2 % and a sputum neutrophilia <80 % from the sample collected at visit 1 (Belda et al., 2000).
- Additional Inclusion Criteria Smokers Group
- Be current smokers with defined smoking history of ≥10 pack years.
- Have normal lung function by post bronchodilator FEV1 ≥80 % of predicted normal, with no evidence of airway obstruction FEV1/FVC ratio ≥70 %.
- Additional Inclusion Criteria Ex-Smokers Group
- Be ex-smokers, with defined smoking history of ≥10 pack years and to have quit smoking at least 1 year before entering the study.
- Have normal lung function by post bronchodilator FEV1 ≥80 % of predicted normal, with no evidence of airway obstruction FEV1/FVC ratio ≥70 %.
Who cannot join
- Current evidence or recent history of any clinically significant disease or abnormality (other than COPD in the subjects with COPD group), which in the opinion of the Investigator, would put the subject at risk, or which would compromise the quality of the study data, including but not limited, to cardiovascular disease, myocardial infarction, cardiac failure, uncontrolled hypertension, life-threatening arrhythmias, uncontrolled diabetes, neurologic or neuromuscular disease, liver disease, gastrointestinal disease or electrolyte abnormalities.
- Females with a positive pregnancy test at visit 1 or 3.
- Females currently breastfeeding.
- Involvement in the planning and conduct of the study.
- Surgery or significant trauma within 3 months of visit 1.
- History of tuberculosis or other non-specific pulmonary diseases such as asthma.
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- Symptoms, signs or laboratory findings suggestive of an ongoing infective illness as judged by the Investigator at visit 1 or 2.
- Participation in any clinical study with an investigational drug in the 4 months prior to visit 1, or participation in a study with a new formulation of a marketed drug in the 3 months prior to visit 1, or participation in a methodology study in the month prior to visit 1.
- Symptoms of any clinically significant illness within 2 weeks prior to visit 1.
- A significant history of alcohol abuse or consumption of more than the recommended units of alcohol per week (28 units for males and 21 units for females).
- A significant history of drug abuse (including benzodiazepines) or a positive test of drug abuse test at visit 1.
- Subjects, who in the opinion of the Investigator should not, for safety or compliance reasons, participate in the study.
- Use of prohibited medications.
- Subjects who have a first degree relative (parents, sibling or child) already enrolled in the study.
- Additional Exclusion Criteria - subjects with COPD
- Recent history of hospitalization due to an exacerbation of airway disease within 3 months of the screening visit or subjects with need for increased treatments for COPD within 6 weeks prior to the screening visit.
- Prior lung volume reduction surgery or history of chest/lung irradiation.
- Regular use of daily oxygen therapy.
- Long standing history and primary diagnosis of asthma.
- Use of systemic steroids within 3 months prior to the screening visit.
- Respiratory tract infection within 6 weeks prior to the screening visit.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Heart Lung Centre, Queen Anne Street Medical Centre
London
About this study
Official title: A Biomarker Study to Compare Gene and Protein Expression Profiles in Four Separate Groups of Subjects Including COPD Cases (GOLD Stage 1-2 and Current Smokers With a ≥ 10 Pack Year Smoking History) and Three Control Groups of Matched Non-smoking Subjects (Never Smoked), Ex-smokers and Current Smokers, to Identify Novel Biomarkers, to Assess Standard Biomarkers of Inflammation and to Compare Inflammatory Cell Responses and Selected Markers of Inflammation in Blood, Induced Sputum and Nasal Samples.
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.
Read the detailed description
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:
- visit 2: 4 to 21 days after screening,
- visit 3: 3-14 days post visit 2, and
- visit 4: 3-14 days post visit 3.
A follow-up telephone call will be conducted 3-10 days post visit 4.
- Conditions
- COPD
- Keywords
- COPD, Biomarkers, Cigarette Smoke, Lung Inflammation, FEV, Sputum
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Cigarette Smoking, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spirometry Measurement: Percentage of Predicted Forced Expiratory Volume in 1 Second (FEV1 %Pred)
Measured: Up to 59 days
Gas Transfer: Percentage of Predicted Total Diffusing Capacity of the Lungs for Carbon Monoxide (TLCO %Pred)
Measured: Up to 59 days
Impulse Oscillometry (IOS) Measurements: Percentage of Predicted Central Airway Resistance at 5Hz (R5 %Pred)
Measured: Up to 59 days
Impulse Oscillometry (IOS) Measurements: Percentage of Predicted Reactance at 5 Hz (X5 % Pred)
Measured: Up to 59 days
Impulse Oscillometry (IOS) Measurements: Resonant Frequency (Fres)
Measured: 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.
Measured: Up to 59 days
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:
- 0: Not troubles by breathlessness except on strenuous exercise
- 1: Short of breath when hurrying or walking up a slight hill
- 2: Walks slower than contemporaries on the level because of breathlessness, or has to stop for breath when walking at own pace
- 3: Stops for breath after about 100 meters or after a few minutes on the level
- 4: Too breathless to leave the house, or breathless when dressing or undressing.
Measured: 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:
- Body mass index: (0 or 1)
- Degree of airflow obstruction (FEV1% Pred): (0 to 3)
- Functional dyspnea (MMRC Dyspnoea Scale): (0 to 3)
- Exercise capacity (VO2max): (0 to 3)
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.
Measured: 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:
- Extent of disease (emphysema): 0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe
- Severity of bronchial dilatation: 0=none; 1=mild (1.5x to 2.5x diameter of pulmonary artery); 2=severe (>2.5x diameter of pulmonary artery)
- Traction bronchiectasis: 0=none; 1=mild (1.5x to 2.5x diameter); 2=severe (>2.5x diameter).
- Total bronchiectasis score derived by adding the bronchial dilatation and traction bronchiectasis scores
- Bronchial wall thickening: 0=none; 1=0.5x; 2=0.5-1x; 3= >1x the diameter of the adjacent pulmonary artery
- Small airways disease: 0=absent, 1=mild, 2=moderate, 3=severe and 4=very severe
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).
Measured: Up to 59 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2013 (estimated)
- Study startJul 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philip Morris Products S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brian Leaker, MD, Principal investigator, Heart Lung Centre, Queen Anne Street Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01780298
- Sponsor's protocol ID
- QASMC 202
- Status last verified
- Jan 2025
- First submitted
- 21 Jan 2013
- Last updated
- 14 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data for transcriptomics (sputum and nasal scrapes) and proteomics (sputum) are published and available via the following links: * Sputum transcriptomics: http://www.ebi.ac.uk/arrayexpress/experiments/E-MTAB-3604/ * Sputum proteomics: http://www.ebi.ac.uk/pride/archive/projects/PXD001977 * Nasal scrapes transcriptomics: http://www.ebi.ac.uk/arrayexpress/experiments/E-MTAB-4015/ * Blood transcriptomics: The link to the Array Express database will be provided upon online publication
Publications
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.
PubMed 26306861Martin 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.
PubMed 26614807Chaudhary 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.
PubMed 29862011Titz 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.
PubMed 27657052
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Biomarker Study to Compare Gene and Protein Expression Profiles in Four Separate Groups of Subjects Including COPD Cases (GOLD Stage 1-2 and Current Smokers With a ≥ 10 Pack Year Smoking History) and Three Control Groups of Matched Non-smoking Subjects (Never Smoked), Ex-smokers and Current Smokers, to Identify Novel Biomarkers, to Assess Standard Biomarkers of Inflammation and to Compare Inflammatory Cell Responses and Selected Markers of Inflammation in Blood, Induced Sputum and Nasal Samples.
- ClinicalTrials.gov ID
- NCT01780298
- Acronym / sponsor ID
- QASMC 202
- Conditions
- COPD
- Keywords
- COPD, Biomarkers, Cigarette Smoke, Lung Inflammation, FEV, Sputum
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Philip Morris Products S.A.Industry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 31 Jan 2013 (estimated)
- Results
- Posted 14 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- visit 2: 4 to 21 days after screening,
- visit 3: 3-14 days post visit 2, and
- visit 4: 3-14 days post visit 3.
A follow-up telephone call will be conducted 3-10 days post visit 4.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (21 listed)
- Provision of signed written informed consent which includes genetic consent.
- Ability to comply with study procedures.
- Males and females aged 40-70 years inclusive.
- Have a body mass index (BMI) between 18 and 35 kg/m2 inclusive and minimum body weights of 50 kg.
- Have a normal physical examination, and have normal laboratory values, 12-lead ECG and vital signs (blood pressure, heart rate and respiratory rate), unless the Investigator considers an abnormality as not clinically significant.
Key exclusion criteria (21 listed)
- Current evidence or recent history of any clinically significant disease or abnormality (other than COPD in the subjects with COPD group), which in the opinion of the Investigator, would put the subject at risk, or which would compromise the quality of the study data, including but not limited, to cardiovascular disease, myocardial infarction, cardiac failure, uncontrolled hypertension, life-threatening arrhythmias, uncontrolled diabetes, neurologic or neuromuscular disease, liver disease, gastrointestinal disease or electrolyte abnormalities.
- Females with a positive pregnancy test at visit 1 or 3.
- Females currently breastfeeding.
- Involvement in the planning and conduct of the study.
- Surgery or significant trauma within 3 months of visit 1.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Spirometry Measurement: Percentage of Predicted Forced Expiratory Volume in 1 Second (FEV1 %Pred)
Time frame: Up to 59 days
Gas Transfer: Percentage of Predicted Total Diffusing Capacity of the Lungs for Carbon Monoxide (TLCO %Pred)
Time frame: Up to 59 days
Impulse Oscillometry (IOS) Measurements: Percentage of Predicted Central Airway Resistance at 5Hz (R5 %Pred)
Time frame: Up to 59 days
Impulse Oscillometry (IOS) Measurements: Percentage of Predicted Reactance at 5 Hz (X5 % Pred)
Time frame: Up to 59 days
Impulse Oscillometry (IOS) Measurements: Resonant Frequency (Fres)
Time frame: Up to 59 days
Stethographics Measurements: Non-Weighted Acoustic Chronic Obstructive Pulmonary Disease Scores (ACOPDS)
Time frame: Up to 59 days
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.
Dyspnoea Assessment: Modified Medical Research Council (MMRC) Dyspnoea Scale
Time frame: Up to 59 days
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: * 0: Not troubles by breathlessness except on strenuous exercise * 1: Short of breath when hurrying or walking up a slight hill * 2: Walks slower than contemporaries on the level because of breathlessness, or has to stop for breath when walking at own pace * 3: Stops for breath after about 100 meters or after a few minutes on the level * 4: Too breathless to leave the house, or breathless when dressing or undressing.
Prediction of Mortality and Hospitalizations: Modified BODE Index (mBODE)
Time frame: Up to 59 days
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: * Body mass index: (0 or 1) * Degree of airflow obstruction (FEV1% Pred): (0 to 3) * Functional dyspnea (MMRC Dyspnoea Scale): (0 to 3) * Exercise capacity (VO2max): (0 to 3) 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.
High-Resolution Computerised Tomography (HRCT) of the Chest
Time frame: Up to 59 days
CT scans were assessed by two radiologists. A scoring system from 0 to 4 was applied, depending upon the component: 1. Extent of disease (emphysema): 0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe 2. Severity of bronchial dilatation: 0=none; 1=mild (1.5x to 2.5x diameter of pulmonary artery); 2=severe (>2.5x diameter of pulmonary artery) 3. Traction bronchiectasis: 0=none; 1=mild (1.5x to 2.5x diameter); 2=severe (>2.5x diameter). 4. Total bronchiectasis score derived by adding the bronchial dilatation and traction bronchiectasis scores 5. Bronchial wall thickening: 0=none; 1=0.5x; 2=0.5-1x; 3= >1x the diameter of the adjacent pulmonary artery 6. Small airways disease: 0=absent, 1=mild, 2=moderate, 3=severe and 4=very severe 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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26306861Titz 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.
- Results publication: PubMed 26614807Martin 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.
- Results publication: PubMed 29862011Chaudhary 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.
- Derived from this study: PubMed 27657052Titz 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 transcriptomicsLink provided by the sponsor.
- Sputum proteomicsLink provided by the sponsor.
- Nasal scrapes transcriptomicsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data for transcriptomics (sputum and nasal scrapes) and proteomics (sputum) are published and available via the following links: * Sputum transcriptomics: http://www.ebi.ac.uk/arrayexpress/experiments/E-MTAB-3604/ * Sputum proteomics: http://www.ebi.ac.uk/pride/archive/projects/PXD001977 * Nasal scrapes transcriptomics: http://www.ebi.ac.uk/arrayexpress/experiments/E-MTAB-4015/ * Blood transcriptomics: The link to the Array Express database will be provided upon online publication
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Chronic Obstructive Pulmonary Disease (COPD), Smoking
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Leaker, MD principal investigator
Heart Lung Centre, Queen Anne Street Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD, run by Philip Morris Products S.A. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spirometry Measurement: Percentage of Predicted Forced Expiratory Volume in 1 Second (FEV1 %Pred) (time frame: Up to 59 days). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01780298, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.