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CompletedNCT01780298Updated Jan 14, 2025Results posted

Chronic Obstructive Pulmonary Disease (COPD) Biomarker Identification Study

An observational study in COPD, sponsored by Philip Morris Products S.A.. Completed at 1 site in United Kingdom. Open to participants aged 40 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-14.

Sponsored by Philip Morris Products S.A. (part of Philip Morris International) · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
252
Ages
40 Years to 70 Years
Sex
All
01

Study 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). 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.

02

Conditions studied

  • COPD

Keywords

  • COPD
  • Biomarkers
  • Cigarette Smoke
  • Lung Inflammation
  • FEV
  • Sputum
03

In context

Pulmonary Disease, Chronic Obstructive

4,252 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 707 are open to participants now.

This study's enrollment of 252 is above the median of 183 across 1,099 observational studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

Philip Morris Products S.A. is the lead sponsor of 49 studies on the registry; none are open to participants now.

Browse Philip Morris Products S.A. studies →All Philip Morris International studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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).
  • 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 %.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
252 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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).

06

What researchers measure

Primary outcomes

  1. Spirometry Measurement: Percentage of Predicted Forced Expiratory Volume in 1 Second (FEV1 %Pred)

    Time frame: Up to 59 days

  2. Gas Transfer: Percentage of Predicted Total Diffusing Capacity of the Lungs for Carbon Monoxide (TLCO %Pred)

    Time frame: Up to 59 days

  3. Impulse Oscillometry (IOS) Measurements: Percentage of Predicted Central Airway Resistance at 5Hz (R5 %Pred)

    Time frame: Up to 59 days

  4. Impulse Oscillometry (IOS) Measurements: Percentage of Predicted Reactance at 5 Hz (X5 % Pred)

    Time frame: Up to 59 days

  5. Impulse Oscillometry (IOS) Measurements: Resonant Frequency (Fres)

    Time frame: Up to 59 days

  6. 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.

    Time frame: Up to 59 days

  7. 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.

    Time frame: Up to 59 days

  8. 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.

    Time frame: Up to 59 days

  9. 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: 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).

    Time frame: Up to 59 days

Other outcomes

  1. 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

    Time frame: Up to 59 days

  2. 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

    Time frame: Up to 59 days

  3. Lipid Markers as Determined by Lipidomic Analysis of Blood Samples

    Reference to be provided upon publication.

    Time frame: Up to 59 days

  4. 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

    Time frame: Up to 59 days

  5. 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

    Time frame: Up to 59 days

  6. mRNA and miRNA (Transcriptomics) Derived From Nasal Epithelial Cells Obtained by Nasal Scrapes

    Reference to be provided upon publication.

    Time frame: Up to 59 days

07

Results

Posted Jan 14, 2025

Participant flow

Study initiated (first subject enrolled): 01 July 2011

Participant flow — Overall Study
MilestoneGroup 1: COPD GOLD Stage 1-2Group 2: Current Cigarette SmokersGroup 3: Ex-SmokersGroup 4: Never Smokers
Started62656461
Completed60606060
Not completed2541
Withdrew: Physician decision1511
Withdrew: Subject not matched1010
Withdrew: Adverse event0020

Outcome measures

PrimarySpirometry Measurement: Percentage of Predicted Forced Expiratory Volume in 1 Second (FEV1 %Pred)
Time frame:
Up to 59 days
Reported as:
Mean · percent of predicted FEV1
Spirometry Measurement: Percentage of Predicted Forced Expiratory Volume in 1 Second (FEV1 %Pred)
percent of predicted FEV1Group 1: COPD GOLD Stage 1-2Group 2: Current Cigarette SmokersGroup 3: Ex-SmokersGroup 4: Never Smokers
Spirometry Measurement: Percentage of Predicted Forced Expiratory Volume in 1 Second (FEV1 %Pred)75.572 (70.905 to 80.239)100.837 (97.801 to 103.873)108.311 (105.102 to 111.519)111.849 (108.258 to 115.440)
Statistical analysis
  • Group 1: COPD GOLD Stage 1-2 vs Group 4: Never Smokers · t-test, 2 sided · p = <0.0001 · Mean difference (final values): -36.278 · 95% CI -42.203 to -30.352Difference Group 1 (COPD) - Group 4 (Never smokers)
  • Group 1: COPD GOLD Stage 1-2 vs Group 3: Ex-Smokers · t-test, 2 sided · p = <0.0001 · Mean difference (final values): -32.739 · 95% CI -38.418 to -27.060Difference Group 1 (COPD) - Group 3 (Ex-smokers)
  • Group 1: COPD GOLD Stage 1-2 vs Group 2: Current Cigarette Smokers · t-test, 2 sided · p = <0.0001 · Mean difference (final values): -25.265 · 95% CI -31.081 to -19.449Difference Group 1 (COPD) - Group 2 (Current cigarette smokers)
  • Group 3: Ex-Smokers vs Group 4: Never Smokers · t-test, 2 sided · p = 0.1504 · Mean difference (final values): -3.538 · 95% CI -8.398 to 1.321Difference Group 3 (Ex-smokers) - Group 4 (Never smokers)
  • Group 2: Current Cigarette Smokers vs Group 3: Ex-Smokers · t-test, 2 sided · p = 0.0002 · Mean difference (final values): -7.474 · 95% CI -11.207 to -3.741Difference Group 2 (Current cigarette smokers) - Group 3 (Ex-smokers)
  • Group 2: Current Cigarette Smokers vs Group 4: Never Smokers · t-test, 2 sided · p = <0.0001 · Mean difference (final values): -11.013 · 95% CI -15.979 to -6.046Difference Group 2 (Current cigarette smokers) - Group 4 (Never smokers)
PrimaryGas Transfer: Percentage of Predicted Total Diffusing Capacity of the Lungs for Carbon Monoxide (TLCO %Pred)
Time frame:
Up to 59 days
Reported as:
Mean · percent predicted TLCO
Gas Transfer: Percentage of Predicted Total Diffusing Capacity of the Lungs for Carbon Monoxide (TLCO %Pred)
percent predicted TLCOGroup 1: COPD GOLD Stage 1-2Group 2: Current Cigarette SmokersGroup 3: Ex-SmokersGroup 4: Never Smokers
Gas Transfer: Percentage of Predicted Total Diffusing Capacity of the Lungs for Carbon Monoxide (TLCO %Pred)66.158 (61.981 to 70.334)80.264 (77.043 to 83.485)90.710 (87.134 to 94.286)93.768 (90.664 to 96.873)
Statistical analysis
  • Group 1: COPD GOLD Stage 1-2 vs Group 4: Never Smokers · t-test, 2 sided · p = <0.0001 · Mean difference (final values): -27.611 · 95% CI -32.249 to -22.973Difference Group 1 (COPD) - Group 4 (Never smokers)
  • Group 1: COPD GOLD Stage 1-2 vs Group 3: Ex-Smokers · t-test, 2 sided · p = <0.0001 · Mean difference (final values): -24.553 · 95% CI -29.501 to -19.604Difference Group 1 (COPD) - Group 3 (Ex-smokers)
  • Group 1: COPD GOLD Stage 1-2 vs Group 2: Current Cigarette Smokers · t-test, 2 sided · p = <0.0001 · Mean difference (final values): -14.107 · 95% CI -19.043 to -9.170Difference Group 1 (COPD) - Group 2 (Current cigarette smokers)
  • Group 3: Ex-Smokers vs Group 4: Never Smokers · t-test, 2 sided · p = 0.0983 · Mean difference (final values): -3.058 · 95% CI -6.702 to 0.585Difference Group 3 (Ex-smokers) - Group 4 (Never smokers)
  • Group 2: Current Cigarette Smokers vs Group 3: Ex-Smokers · t-test, 2 sided · p = <0.0001 · Mean difference (final values): -10.446 · 95% CI -13.845 to -7.047Difference Group 2 (Current cigarette smokers) - Group 3 (Ex-smokers)
  • Group 2: Current Cigarette Smokers vs Group 4: Never Smokers · t-test, 2 sided · p = <0.0001 · Mean difference (final values): -13.504 · 95% CI -17.302 to -9.707Difference Group 2 (Current cigarette smokers) - Group 4 (Never smokers)
PrimaryImpulse Oscillometry (IOS) Measurements: Percentage of Predicted Central Airway Resistance at 5Hz (R5 %Pred)
Time frame:
Up to 59 days
Reported as:
Mean · percent predicted R5
Impulse Oscillometry (IOS) Measurements: Percentage of Predicted Central Airway Resistance at 5Hz (R5 %Pred)
percent predicted R5Group 1: COPD GOLD Stage 1-2Group 2: Current Cigarette SmokersGroup 3: Ex-SmokersGroup 4: Never Smokers
Impulse Oscillometry (IOS) Measurements: Percentage of Predicted Central Airway Resistance at 5Hz (R5 %Pred)130.118 (119.600 to 140.637)109.458 (102.529 to 116.386)103.581 (97.437 to 109.724)89.671 (83.477 to 95.865)
Statistical analysis
  • Group 1: COPD GOLD Stage 1-2 vs Group 4: Never Smokers · t-test, 2 sided · p = <0.0001 · Mean difference (final values): 40.448 · 95% CI 28.374 to 52.521Difference Group 1 (COPD) - Group 4 (Never smokers)
  • Group 1: COPD GOLD Stage 1-2 vs Group 3: Ex-Smokers · t-test, 2 sided · p = <0.0001 · Mean difference (final values): 26.538 · 95% CI 14.890 to 38.185Difference Group 1 (COPD) - Group 3 (Ex-smokers)
  • Group 1: COPD GOLD Stage 1-2 vs Group 2: Current Cigarette Smokers · t-test, 2 sided · p = 0.0018 · Mean difference (final values): 20.661 · 95% CI 7.997 to 33.324Difference Group 1 (COPD) - Group 2 (Current cigarette smokers)
  • Group 3: Ex-Smokers vs Group 4: Never Smokers · t-test, 2 sided · p = 0.0015 · Mean difference (final values): 13.910 · 95% CI 5.534 to 22.286Difference Group 3 (Ex-smokers) - Group 4 (Never smokers)
  • Group 2: Current Cigarette Smokers vs Group 3: Ex-Smokers · t-test, 2 sided · p = 0.1847 · Mean difference (final values): 5.877 · 95% CI -2.886 to 14.639Difference Group 2 (Current cigarette smokers) - Group 3 (Ex-smokers)
  • Group 2: Current Cigarette Smokers vs Group 4: Never Smokers · t-test, 2 sided · p = 0.0003 · Mean difference (final values): 19.787 · 95% CI 9.536 to 30.038Difference Group 2 (Current cigarette smokers) - Group 4 (Never smokers)
PrimaryImpulse Oscillometry (IOS) Measurements: Percentage of Predicted Reactance at 5 Hz (X5 % Pred)
Time frame:
Up to 59 days
Reported as:
Mean · percent predicted X5
Impulse Oscillometry (IOS) Measurements: Percentage of Predicted Reactance at 5 Hz (X5 % Pred)
percent predicted X5Group 1: COPD GOLD Stage 1-2Group 2: Current Cigarette SmokersGroup 3: Ex-SmokersGroup 4: Never Smokers
Impulse Oscillometry (IOS) Measurements: Percentage of Predicted Reactance at 5 Hz (X5 % Pred)2808.259 (-794.944 to 6411.462)411.670 (-139.923 to 963.263)491.128 (41.793 to 940.464)5787.984 (-902.669 to 12478.637)
Statistical analysis
  • Group 1: COPD GOLD Stage 1-2 vs Group 4: Never Smokers · t-test, 2 sided · p = 0.1981 · Mean difference (final values): -2979.725 · 95% CI -7560.258 to 1600.808Difference Group 1 (COPD) - Group 4 (Never smokers)
  • Group 1: COPD GOLD Stage 1-2 vs Group 3: Ex-Smokers · t-test, 2 sided · p = 0.1956 · Mean difference (final values): 2317.131 · 95% CI -1224.786 to 5859.048Difference Group 1 (COPD) - Group 3 (Ex-smokers)
  • Group 1: COPD GOLD Stage 1-2 vs Group 2: Current Cigarette Smokers · t-test, 2 sided · p = 0.2077 · Mean difference (final values): 2396.589 · 95% CI -1367.692 to 6160.870Difference Group 1 (COPD) - Group 2 (Current cigarette smokers)
  • Group 3: Ex-Smokers vs Group 4: Never Smokers · t-test, 2 sided · p = 0.1154 · Mean difference (final values): -5296.856 · 95% CI -11930.190 to 1336.478Difference Group 3 (Ex-smokers) - Group 4 (Never smokers)
  • Group 2: Current Cigarette Smokers vs Group 3: Ex-Smokers · t-test, 2 sided · p = 0.8095 · Mean difference (final values): -79.458 · 95% CI -736.151 to 577.234Difference Group 2 (Current cigarette smokers) - Group 3 (Ex-smokers)
  • Group 2: Current Cigarette Smokers vs Group 4: Never Smokers · t-test, 2 sided · p = 0.1113 · Mean difference (final values): -5376.314 · 95% CI -12030.714 to 1278.085Difference Group 2 (Current cigarette smokers) - Group 4 (Never smokers)
PrimaryImpulse Oscillometry (IOS) Measurements: Resonant Frequency (Fres)
Time frame:
Up to 59 days
Reported as:
Mean · Hz
Impulse Oscillometry (IOS) Measurements: Resonant Frequency (Fres)
HzGroup 1: COPD GOLD Stage 1-2Group 2: Current Cigarette SmokersGroup 3: Ex-SmokersGroup 4: Never Smokers
Impulse Oscillometry (IOS) Measurements: Resonant Frequency (Fres)17.816 (16.588 to 19.043)14.362 (13.513 to 15.210)12.971 (12.083 to 13.859)11.800 (10.942 to 12.659)
Statistical analysis
  • Group 1: COPD GOLD Stage 1-2 vs Group 4: Never Smokers · t-test, 2 sided · p = <0.0001 · Mean difference (final values): 6.015 · 95% CI 4.510 to 7.521Difference Group 1 (COPD) - Group 4 (Never smokers)
  • Group 1: COPD GOLD Stage 1-2 vs Group 3: Ex-Smokers · t-test, 2 sided · p = <0.0001 · Mean difference (final values): 4.845 · 95% CI 3.379 to 6.310Difference Group 1 (COPD) - Group 3 (Ex-smokers)
  • Group 1: COPD GOLD Stage 1-2 vs Group 2: Current Cigarette Smokers · t-test, 2 sided · p = <0.0001 · Mean difference (final values): 3.454 · 95% CI 1.923 to 4.984Difference Group 1 (COPD) - Group 2 (Current cigarette smokers)
  • Group 3: Ex-Smokers vs Group 4: Never Smokers · t-test, 2 sided · p = 0.0418 · Mean difference (final values): 1.171 · 95% CI 0.045 to 2.296Difference Group 3 (Ex-smokers) - Group 4 (Never smokers)
  • Group 2: Current Cigarette Smokers vs Group 3: Ex-Smokers · t-test, 2 sided · p = 0.0357 · Mean difference (final values): 1.391 · 95% CI 0.096 to 2.686Difference Group 2 (Current cigarette smokers) - Group 3 (Ex-smokers)
  • Group 2: Current Cigarette Smokers vs Group 4: Never Smokers · t-test, 2 sided · p = 0.0001 · Mean difference (final values): 2.562 · 95% CI 1.303 to 3.820Difference Group 2 (Current cigarette smokers) - Group 4 (Never smokers)
PrimaryStethographics 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.

Time frame:
Up to 59 days
Reported as:
Mean · score on a scale
Stethographics Measurements: Non-Weighted Acoustic Chronic Obstructive Pulmonary Disease Scores (ACOPDS)
score on a scaleGroup 1: COPD GOLD Stage 1-2Group 2: Current Cigarette SmokersGroup 3: Ex-SmokersGroup 4: Never Smokers
Stethographics Measurements: Non-Weighted Acoustic Chronic Obstructive Pulmonary Disease Scores (ACOPDS)47.983 (42.723 to 53.244)18.817 (14.467 to 23.166)12.192 (9.025 to 15.358)8.350 (6.187 to 10.513)
Statistical analysis
  • Group 1: COPD GOLD Stage 1-2 vs Group 4: Never Smokers · t-test, 2 sided · p = <0.0001 · Mean difference (final values): 39.633 · 95% CI 33.964 to 45.302Difference Group 1 (COPD) - Group 4 (Never smokers)
  • Group 1: COPD GOLD Stage 1-2 vs Group 3: Ex-Smokers · t-test, 2 sided · p = <0.0001 · Mean difference (final values): 35.792 · 95% CI 29.761 to 41.822Difference Group 1 (COPD) - Group 3 (Ex-smokers)
  • Group 1: COPD GOLD Stage 1-2 vs Group 2: Current Cigarette Smokers · t-test, 2 sided · p = <0.0001 · Mean difference (final values): 29.167 · 95% CI 23.445 to 34.888Difference Group 1 (COPD) - Group 2 (Current cigarette smokers)
  • Group 3: Ex-Smokers vs Group 4: Never Smokers · t-test, 2 sided · p = 0.0418 · Mean difference (final values): 3.842 · 95% CI 0.147 to 7.536Difference Group 3 (Ex-smokers) - Group 4 (Never smokers)
  • Group 2: Current Cigarette Smokers vs Group 3: Ex-Smokers · t-test, 2 sided · p = 0.0084 · Mean difference (final values): 6.625 · 95% CI 1.763 to 11.487Difference Group 2 (Current cigarette smokers) - Group 3 (Ex-smokers)
  • Group 2: Current Cigarette Smokers vs Group 4: Never Smokers · t-test, 2 sided · p = <0.0001 · Mean difference (final values): 10.467 · 95% CI 5.888 to 15.045Difference Group 2 (Current cigarette smokers) - Group 4 (Never smokers)
PrimaryDyspnoea 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.

Time frame:
Up to 59 days
Reported as:
Mean · units on a scale
Dyspnoea Assessment: Modified Medical Research Council (MMRC) Dyspnoea Scale
units on a scaleGroup 1: COPD GOLD Stage 1-2Group 2: Current Cigarette SmokersGroup 3: Ex-SmokersGroup 4: Never Smokers
Dyspnoea Assessment: Modified Medical Research Council (MMRC) Dyspnoea Scale1.053 (0.821 to 1.285)0.417 (0.272 to 0.562)0.186 (0.073 to 0.300)0.119 (-0.001 to 0.238)
Statistical analysis
  • Group 1: COPD GOLD Stage 1-2 vs Group 4: Never Smokers · t-test, 2 sided · p = <0.0001 · Mean difference (final values): 0.929 · 95% CI 0.654 to 1.203Difference Group 1 (COPD) - Group 4 (Never smokers)
  • Group 1: COPD GOLD Stage 1-2 vs Group 3: Ex-Smokers · t-test, 2 sided · p = <0.0001 · Mean difference (final values): 0.875 · 95% CI 0.609 to 1.141Difference Group 1 (COPD) - Group 3 (Ex-smokers)
  • Group 1: COPD GOLD Stage 1-2 vs Group 2: Current Cigarette Smokers · t-test, 2 sided · p = <0.0001 · Mean difference (final values): 0.649 · 95% CI 0.386 to 0.912Difference Group 1 (COPD) - Group 2 (Current cigarette smokers)
  • Group 3: Ex-Smokers vs Group 4: Never Smokers · t-test, 2 sided · p = 0.3985 · Mean difference (final values): 0.069 · 95% CI -0.093 to 0.231Difference Group 3 (Ex-smokers) - Group 4 (Never smokers)
  • Group 2: Current Cigarette Smokers vs Group 3: Ex-Smokers · t-test, 2 sided · p = 0.0267 · Mean difference (final values): 0.220 · 95% CI 0.026 to 0.414Difference Group 2 (Current cigarette smokers) - Group 3 (Ex-smokers)
  • Group 2: Current Cigarette Smokers vs Group 4: Never Smokers · t-test, 2 sided · p = 0.0036 · Mean difference (final values): 0.305 · 95% CI 0.104 to 0.506Difference Group 2 (Current cigarette smokers) - Group 4 (Never smokers)
PrimaryPrediction 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.

Time frame:
Up to 59 days
Reported as:
Mean · score on a scale
Prediction of Mortality and Hospitalizations: Modified BODE Index (mBODE)
score on a scaleGroup 1: COPD GOLD Stage 1-2Group 2: Current Cigarette SmokersGroup 3: Ex-SmokersGroup 4: Never Smokers
Prediction of Mortality and Hospitalizations: Modified BODE Index (mBODE)2.357 (1.998 to 2.716)1.254 (1.035 to 1.474)1.051 (0.827 to 1.275)0.763 (0.555 to 0.970)
Statistical analysis
  • Group 1: COPD GOLD Stage 1-2 vs Group 4: Never Smokers · t-test, 2 sided · p = <0.0001 · Mean difference (final values): 1.564 · 95% CI 1.179 to 1.949Difference Group 1 (COPD) - Group 4 (Never smokers)
  • Group 1: COPD GOLD Stage 1-2 vs Group 3: Ex-Smokers · t-test, 2 sided · p = <0.0001 · Mean difference (final values): 1.291 · 95% CI 0.924 to 1.658Difference Group 1 (COPD) - Group 3 (Ex-smokers)
  • Group 1: COPD GOLD Stage 1-2 vs Group 2: Current Cigarette Smokers · t-test, 2 sided · p = <0.0001 · Mean difference (final values): 1.073 · 95% CI 0.724 to 1.421Difference Group 1 (COPD) - Group 2 (Current cigarette smokers)
  • Group 3: Ex-Smokers vs Group 4: Never Smokers · t-test, 2 sided · p = 0.0282 · Mean difference (final values): 0.276 · 95% CI 0.031 to 0.521Difference Group 3 (Ex-smokers) - Group 4 (Never smokers)
  • Group 2: Current Cigarette Smokers vs Group 3: Ex-Smokers · t-test, 2 sided · p = 0.1223 · Mean difference (final values): 0.207 · 95% CI -0.057 to 0.471Difference Group 2 (Current cigarette smokers) - Group 3 (Ex-smokers)
  • Group 2: Current Cigarette Smokers vs Group 4: Never Smokers · t-test, 2 sided · p = <0.0001 · Mean difference (final values): 0.492 · 95% CI 0.273 to 0.710Difference Group 2 (Current cigarette smokers) - Group 4 (Never smokers)
PrimaryHigh-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: 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).

Time frame:
Up to 59 days
Reported as:
Mean · score on a scale
High-Resolution Computerised Tomography (HRCT) of the Chest
score on a scaleGroup 1: COPD GOLD Stage 1-2Group 2: Current Cigarette SmokersGroup 3: Ex-SmokersGroup 4: Never Smokers
High-Resolution Computerised Tomography (HRCT) of the Chest0.939 (0.867 to 1.011)0.803 (0.723 to 0.884)0.683 (0.613 to 0.753)0.567 (0.488 to 0.646)
Statistical analysis
  • Group 1: COPD GOLD Stage 1-2 vs Group 4: Never Smokers · t-test, 2 sided · p = <0.0001 · Mean difference (final values): 0.372 · 95% CI 0.269 to 0.478Difference Group 1 (COPD) - Group 4 (Never smokers)
  • Group 1: COPD GOLD Stage 1-2 vs Group 3: Ex-Smokers · t-test, 2 sided · p = <0.0001 · Mean difference (final values): 0.256 · 95% CI 0.158 to 0.354Difference Group 1 (COPD) - Group 3 (Ex-smokers)
  • Group 1: COPD GOLD Stage 1-2 vs Group 2: Current Cigarette Smokers · t-test, 2 sided · p = 0.0199 · Mean difference (final values): 0.136 · 95% CI 0.022 to 0.249Difference Group 1 (COPD) - Group 2 (Current cigarette smokers)
  • Group 3: Ex-Smokers vs Group 4: Never Smokers · t-test, 2 sided · p = 0.0247 · Mean difference (final values): 0.117 · 95% CI 0.015 to 0.218Difference Group 3 (Ex-smokers) - Group 4 (Never smokers)
  • Group 2: Current Cigarette Smokers vs Group 3: Ex-Smokers · t-test, 2 sided · p = 0.0204 · Mean difference (final values): 0.120 · 95% CI 0.019 to 0.221Difference Group 2 (Current cigarette smokers) - Group 3 (Ex-smokers)
  • Group 2: Current Cigarette Smokers vs Group 4: Never Smokers · t-test, 2 sided · p = <0.0001 · Mean difference (final values): 0.237 · 95% CI 0.127 to 0.347Difference Group 2 (Current cigarette smokers) - Group 4 (Never smokers)
Other pre-specifiedTotal 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

Time frame:
Up to 59 days

Results for this outcome have not been posted.

Other pre-specifiedProtein 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

Time frame:
Up to 59 days

Results for this outcome have not been posted.

Other pre-specifiedLipid Markers as Determined by Lipidomic Analysis of Blood Samples

Reference to be provided upon publication.

Time frame:
Up to 59 days

Results for this outcome have not been posted.

Other pre-specifiedmRNA 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

Time frame:
Up to 59 days

Results for this outcome have not been posted.

Other pre-specifiedmRNA 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

Time frame:
Up to 59 days

Results for this outcome have not been posted.

Other pre-specifiedmRNA and miRNA (Transcriptomics) Derived From Nasal Epithelial Cells Obtained by Nasal Scrapes

Reference to be provided upon publication.

Time frame:
Up to 59 days

Results for this outcome have not been posted.

Adverse events

Collected over From the informed consent form until the end of the study.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Group 1: COPD GOLD Stage 1-2—0/62 (0%)42/62 (67.7%)
Group 2: Current Cigarette Smokers—0/65 (0%)51/65 (78.5%)
Group 3: Ex-Smokers—0/64 (0%)35/64 (54.7%)
Group 4: Never Smokers—0/61 (0%)40/61 (65.6%)
Most frequent other events
Most frequent other events
EventGroup 1: COPD GOLD Stage 1-2Group 2: Current Cigarette SmokersGroup 3: Ex-SmokersGroup 4: Never Smokers
Computerised tomogram abnormalInvestigations12/6228/6515/6424/61
Pulmonary function challenge test abnormalInvestigations9/6216/6512/6415/61
Lung neoplasmNeoplasms benign, malignant and unspecified (incl cysts and polyps)14/6212/657/644/61
HeadacheNervous system disorders10/626/654/647/61
Liver scan abnormalInvestigations6/620/651/642/61
EmphysemaRespiratory, thoracic and mediastinal disorders1/626/651/640/61
NasopharyngitisInfections and infestations3/624/653/645/61
Bronchial wall thickeningRespiratory, thoracic and mediastinal disorders0/620/650/644/61
InfluenzaInfections and infestations3/624/652/640/61

Baseline characteristics

Age, Continuous
Age, Continuous(years)Group 1: COPD GOLD Stage 1-2Group 2: Current Cigarette SmokersGroup 3: Ex-SmokersGroup 4: Never SmokersTotal
Mean57.161 ± 7.15955.308 ± 6.90856.344 ± 7.39255.459 ± 7.45356.063 ± 7.223
Sex: Female, Male
Sex: Female, Male(Participants)Group 1: COPD GOLD Stage 1-2Group 2: Current Cigarette SmokersGroup 3: Ex-SmokersGroup 4: Never SmokersTotal
Female25292726107
Male37363735145
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Group 1: COPD GOLD Stage 1-2Group 2: Current Cigarette SmokersGroup 3: Ex-SmokersGroup 4: Never SmokersTotal
American Indian or Alaska Native00000
Asian00000
Native Hawaiian or Other Pacific Islander00000
Black or African American11114
White60646360247
More than one race00000
Unknown or Not Reported10001
Body Mass Index
Body Mass Index(kg/m^2)Group 1: COPD GOLD Stage 1-2Group 2: Current Cigarette SmokersGroup 3: Ex-SmokersGroup 4: Never SmokersTotal
Mean26.461 ± 3.70027.568 ± 3.65727.333 ± 3.55826.479 ± 3.71926.972 ± 3.670
Number of Cigarettes Smoked Per Day
Number of Cigarettes Smoked Per Day(Cig/day)Group 1: COPD GOLD Stage 1-2Group 2: Current Cigarette SmokersGroup 3: Ex-SmokersGroup 4: Never SmokersTotal
Mean20.611 ± 9.41217.319 ± 7.54122.422 ± 9.1350 ± 015.233 ± 11.611
Pack-year
Pack-year(Pack-year)Group 1: COPD GOLD Stage 1-2Group 2: Current Cigarette SmokersGroup 3: Ex-SmokersGroup 4: Never SmokersTotal
Mean44.770 ± 22.01933.404 ± 14.57728.535 ± 13.3300 ± 026.878 ± 21.977
Weekly Consumption of Alcohol
Weekly Consumption of Alcohol(Units of alcohol)Group 1: COPD GOLD Stage 1-2Group 2: Current Cigarette SmokersGroup 3: Ex-SmokersGroup 4: Never SmokersTotal
Mean6.694 ± 7.6625.923 ± 6.3108.445 ± 7.0975.775 ± 6.7116.717 ± 6.998
08

Study locations

1 site
  • Heart Lung Centre, Queen Anne Street Medical Centre
    London, United Kingdom
09

References and documents

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 26306861 ↗
  • 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. PubMed 26614807 ↗
  • 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. PubMed 29862011 ↗
  • 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. PubMed 27657052 ↗

Individual participant data

Plan to share: 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

Time frame: Immediately following publication. No end date.

Access criteria: Anyone who wishes to access the data.

Data sharing details ↗ · doi.org

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01780298
Lead sponsor
Philip Morris Products S.A.
Responsible party
Sponsor
First posted
Jan 31, 2013
Start date
Jul 2011
Primary completion
Dec 2012
Completion
Dec 2012
Results posted
Jan 14, 2025
Last update
Jan 14, 2025

Study contacts

Brian Leaker, MD
principal investigator · Heart Lung Centre, Queen Anne Street Medical Centre

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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