An observational study in Pulmonary Disease, Chronic Obstructive, sponsored by GlaxoSmithKline. Completed at 41 sites in China. Open to participants aged 50 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-20.
Sponsored by GlaxoSmithKline · Observational
This is a non-drug interventional cohort study, which aims to investigate the clinical, radiological and biological factors associated with disease progression in COPD in China. Participants will be recruited from multiple hospitals across Guangdong province categorized as Type A hospitals (those at prefecture-level and above) and Type B hospitals (those below prefecture-level).
5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.
This study's enrollment of 2,005 is above the median of 158 across 1,497 observational studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 118 are open to participants now.
Of its 264 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants with COPD, chronic bronchitis without fixed airflow limitation and never smoker healthy participants will be included 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.
Additional inclusion criteria for participants:
Additional inclusion criteria for chronic bronchitis participants:
Additional inclusion criteria for healthy participants:
Exclusion criteria:
Additional exclusion criteria for COPD participants:
Additional exclusion criteria for chronic bronchitis participants and healthy participants:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD, chronic bronchitis and healthy participants (never smoker) from Type A and Type B hospitals will be included.
Other: Prospective observational cohort study
COPD, chronic bronchitis and healthy participants (never smoker) from selected Type A hospitals will be included.
Other: Prospective observational cohort study
Prospective observational cohort study
Main Cohort: Change From Baseline in Pre-bronchodilator and Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Month 30
FEV1 is a measure of lung function and is defined as the volume of air that can be forced out in one second after taking a deep breath. FEV1 was measured electronically by spirometry. Baseline value was the assessment with a non-missing value at Day 1 of Month 1. Change from Baseline was calculated as the value at Month 30 minus the value at Baseline. Change from Baseline in pre- and post-bronchodilator FEV1 was assessed and summarized. Also, yearly rate of change in FEV1 (pre- and post-bronchodilator) was analyzed using random coefficients models.
Time frame: Baseline (Day 1 of Month 1) and at Month 30
Main Cohort: Change From Baseline in Pre-bronchodilator and Post-bronchodilator Forced Vital Capacity (FVC) at Month 30
FVC is the total amount of air exhaled during FEV test and is a lung function test that is measured during spirometry. Baseline value was the assessment with a non-missing value at Day 1 of Month 1. Change from Baseline was calculated as the value at Month 30 minus the value at Baseline. Change from Baseline in pre- and post-bronchodilator FVC was assessed and summarized. Also, yearly rate of change in FVC (pre- and post-bronchodilator) was analyzed using random coefficients models.
Time frame: Baseline (Day 1 of Month 1) and at Month 30
Main Cohort: Rate of Moderate/Severe Exacerbations in COPD and Chronic Bronchitis Cohorts
Moderate exacerbations are defined as COPD exacerbations that require either systemic corticosteroids (intramuscular, intravenous, or oral) and/or antibiotics. Severe exacerbations are defined as COPD exacerbations requiring hospitalization (including intubation and admittance to an intensive care unit) or result in death. Exacerbation rate = number of moderate or sever exacerbation divided by total participants-years. Analysis performed using a generalized linear model assuming a negative binomial distribution with covariates of type of participants (i.e. GOLD I-IV and chronic bronchitis), gender, smoking status, exacerbation history (moderate/severe), site (type of hospital), maintenance therapy (Y/N) and inhaled corticosteroid (ICS) containing (Y/N), Childhood chest disease (Y/N) and biomass fuel exposure (Y/N), age, and with offset logarithm of time on study.
Time frame: Up to 30 months
Main Cohort: Change From Baseline in COPD Assessment Test (CAT) Score at Month 30
The CAT is a validated 8-items questionnaire developed for use in routine clinical practice to measure the health status of participants with COPD. Participants rate their experience on a 6-point scale, ranging from 0 (no impairment) to 5 (maximum impairment), higher score indicates greater impairment. A total CAT score was calculated by summing the non-missing scores of the eight items with a scoring range of 0 (no disease impact) to 40 (maximum disease impact). Higher scores indicated greater disease impact. Baseline value was the assessment with a non-missing value at Day 1 of Month 1. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Time frame: Baseline (Day 1 of Month 1) and at Month 30
Main Cohort: Absolute Values of CAT Score at Month 30
The CAT is a validated 8-items questionnaire developed for use in routine clinical practice to measure the health status of participants with COPD. Participants rate their experience on a 6-point scale, ranging from 0 (no impairment) to 5 (maximum impairment), higher score indicates greater impairment. A total CAT score was calculated by summing the non-missing scores of the eight items with a scoring range of 0 (no disease impact) to 40 (maximum disease impact). Higher scores indicated greater disease impact.
Time frame: At Month 30
Main Cohort: Total Score of COPD Assessment in Primary Care to Identify Undiagnosed Respiratory Disease and Exacerbation Risk (CAPTURE) at Baseline
The CATPURE is a short, five-item questionnaire that can be easily completed by participants and are used to identify individuals who may have undiagnosed, clinically significant COPD. The algorithm is a simple summation of participants responses to each of the five items. For Question 1-4: Score 0 for 'No' and Score 1 for 'Yes'; Question 5: Score 0 for 'None', 1 for 'Once' and 2 for '2 or more'. Total score is ranging from 0 to 6, higher score means higher risk of COPD (0-1 is at low risk, 2-6 is at high risk). Baseline value was the assessment with a non-missing value at Day 1 of Month 1.
Time frame: At Baseline (Day 1 of Month 1)
Main Cohort: Total Score of CAPTURE at Month 18
The CATPURE is a short, five-item questionnaire that can be easily completed by participants and are used to identify individuals who may have undiagnosed, clinically significant COPD. The algorithm is a simple summation of participants responses to each of the five items. For Question 1-4: Score 0 for 'No' and Score 1 for 'Yes'; Question 5: Score 0 for 'None', 1 for 'Once' and 2 for '2 or more'. Total score is ranging from 0 to 6, higher score means higher risk of COPD (0-1 is at low risk, 2-6 is at high risk).
Time frame: At Month 18
Main Cohort: Number of Participants With Any Clinically Important Deterioration (CID) Event and Its Components From Baseline to Month 6
CID was defined as decrease of greater than or equal to (\>=) 100 milliliter (mL) in post-bronchodilator FEV1 or increase of \>=2 units in the CAT, or an occurrence of a moderate/severe exacerbation. CID was derived from three key clinical assessments: 1. moderate/severe exacerbations, 2. worsening of FEV1, and 3. worsening of health status using the CAT questionnaire. Baseline value was the assessment with a non-missing value at Day 1 of Month 1. A participant may have more than one CID components, hence total of participants with individual CID components may not match with participants with 'Any CID' category. Number of participants with any CID event and its components (Exacerbation CID, FEV1 CID and CAT CID) observed from Baseline to Month 6 have been presented.
Time frame: Baseline (Day 1 of Month 1) to Month 6
Main Cohort: Number of Participants With Any CID Event and Its Components From Months 6 to 18
CID was defined as: decrease of greater than or equal to (\>=) 100 milliliter (mL) in post-bronchodilator FEV1 or increase of \>=2 units in the CAT, or an occurrence of a moderate/severe exacerbation. CID was derived from three key clinical assessments: 1. moderate/severe exacerbations, 2. worsening of FEV1, and 3. worsening of health status using the CAT questionnaire. A participant may have more than one CID components, hence total of participants with individual CID components may not match with participants with 'Any CID' category. Number of participants with any CID event and its components (Exacerbation CID, FEV1 CID and CAT CID) observed from Months 6 to 18 have been presented.
Time frame: Months 6 to 18
Main Cohort: Number of Participants With Any CID Event and Its Components From Months 18 to 30
CID was defined as: decrease of greater than or equal to (\>=) 100 milliliter (mL) in post-bronchodilator FEV1 or increase of \>=2 units in the CAT, or an occurrence of a moderate/severe exacerbation. CID was derived from three key clinical assessments: 1. moderate/severe exacerbations, 2. worsening of FEV1, and 3. worsening of health status using the CAT questionnaire. A participant may have more than one CID components, hence total of participants with individual CID components may not match with participants with 'Any CID' category. Number of participants with any CID event and its components (Exacerbation CID, FEV1 CID and CAT CID) observed from Months 18 to 30 have been presented.
Time frame: Months 18 to 30
Main Cohort: Number of Participants Who Died
Number of participants who died during study have been presented.
Time frame: Up to 30 months
Sub-cohort: Change From Baseline in Evaluating Respiratory Symptoms in COPD (E-RS:COPD) Total Scores From Months 1 to 6
E-RS: COPD is a subset of Exacerbations of Chronic pulmonary Disease Tool (EXACT). E-RS: COPD is a tool that consists of 11 items from the 14 item EXACT instrument. The domains include: respiratory symptoms-breathlessness (RS-BRL) comprised of 5 items (2 items scored from 0-4 and 3 items scored from 0-3); RS-cough and sputum (RS-CSP) comprised of 3 items(2 items scored from 0-4 and 1 item scored from 0-3);and RS-chest symptoms (RS-CSY) comprised of 3 items (scored from 0-4). The total score was calculated by taking sum of all individual 11 item scores, which ranges between 0-40 and higher score indicates more severe symptoms. Baseline value was the assessment with a non-missing value at Day 1 of Month 1. The 1 to 6 month E-RS:COPD total score value was derived by calculating the average of E-RS:COPD total scores collected between month 1 and 6. Change from Baseline was calculated by subtracting Baseline value from 1-6 month average total score value.
Time frame: Baseline (Day 1 of Month 1) and Months 1 to 6
Sub-cohort: Change From Baseline in E-RS:COPD Total Scores From Months 18 to 24
E-RS: COPD is a subset of Exacerbations of Chronic pulmonary Disease Tool (EXACT). E-RS: COPD is a tool that consists of 11 items from the 14 item EXACT instrument. The domains include: respiratory symptoms-breathlessness (RS-BRL) comprised of 5 items (2 items scored from 0-4 and 3 items scored from 0-3); RS-cough and sputum (RS-CSP) comprised of 3 items(2 items scored from 0-4 and 1 item scored from 0-3);and RS-chest symptoms (RS-CSY) comprised of 3 items (scored from 0-4). The total score was calculated by taking sum of all individual 11 item scores, which ranges between 0-40 and higher score indicates more severe symptoms. Baseline value was the assessment with a non-missing value at Day 1 of Month 1. The 18 to 24 month E-RS:COPD total score value was derived by calculating the average of E-RS:COPD total scores collected between month 18 and 24. Change from Baseline was calculated by subtracting Baseline value from 18-24 month average total score value.
Time frame: Baseline (Day 1 of Month 1) and Months 18 to 24
Sub-cohort: Number of Participants With Exacerbation of COPD Tool (EXACT) Events From Months 1 to 6
The EXACT is a 14-item daily diary designed to provide a measure of patient-reported symptoms of COPD exacerbation. An EXACT Total Score, ranging from 0 to 100, where higher scores indicate a more severe condition. EXACT events were defined as magnitude of responder for symptomatic events defined as acute, sustained symptomatic worsening of COPD, defined as an increase in EXACT score \>=9 points for 3 days or \>=12 points for 2 days, above Baseline (Baseline value is average of 7-day period \[Day 1 to 7\]). Number of participants with EXACT events observed from Months 1 to 6 have been presented.
Time frame: Months 1 to 6
Sub-cohort: Number of Participants With EXACT Events From Months 18 to 24
The EXACT is a 14-item daily diary designed to provide a measure of patient-reported symptoms of COPD exacerbation. An EXACT Total Score, ranging from 0 to 100, where higher scores indicate a more severe condition. EXACT events were defined as magnitude of responder for symptomatic events defined as acute, sustained symptomatic worsening of COPD, defined as an increase in EXACT score \>=9 points for 3 days or \>=12 points for 2 days, above Baseline (Baseline value is average of 7-day period \[Day 1 to 7\]). Number of participants with EXACT events observed from Months 18 to 24 have been presented.
Time frame: Months 18 to 24
Sub-cohort: Absolute Values of Digital Physical Activity at Baseline (Average of Days 1 to 7)
Digital physical activity was evaluated by daily steps as assessed by a wrist band dispensed at Baseline. Participants were required to keep wearing the wrist band. The daily step data was based on the daily average steps (steps per day) for each participant. Baseline value was derived as the average value of first 7 days (Days 1 to 7 at Month 1).
Time frame: At Baseline (Days 1 to 7 at Month 1)
Sub-cohort: Absolute Values of Digital Physical Activity at Month 1 (Average of Day 8 to Month 1)
Digital physical activity was evaluated by daily steps as assessed by a wrist band dispensed at Baseline. Participants were required to keep wearing the wrist band. The daily step data was based on the daily average steps (steps per day) for each participant. Month 1 value was derived as the average of daily step data up to 30 days from study Day 8.
Time frame: Up to 30 days from study Day 8
Sub-cohort: Absolute Values of Digital Physical Activity at Month 18 (Average of Months 18 to 19)
Digital physical activity was evaluated by daily steps as assessed by a wrist band dispensed at Baseline. Participants were required to keep wearing the wrist band. The daily step data was based on the daily average steps (steps per day) for each participant. Month 18 value was derived as the average of daily step data up to 30 days from Month 18.
Time frame: Up to 30 days from Month 18 (Months 18 to 19)
Main Cohort: Absolute Values of Plasma Fibrinogen at Baseline
Fibrinogen is a protein, specifically a clotting factor (factor I), that is essential for proper blood clot formation. Blood samples were collected to evaluate the amount of fibrinogen. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.
Time frame: At Baseline (Day 1 of Month 1)
Main Cohort: Absolute Values of Plasma Fibrinogen at Month 30
Fibrinogen is a protein, specifically a clotting factor (factor I), that is essential for proper blood clot formation. Blood samples were collected to evaluate the amount of fibrinogen.
Time frame: At Month 30
Main Cohort: Absolute Values of C-Reactive Protein at Baseline
Blood samples were collected for the analysis of C-Reactive Protein. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.
Time frame: At Baseline (Day 1 of Month 1)
Main Cohort: Absolute Values of C-Reactive Protein at Month 30
Blood samples were collected for the analysis of C-Reactive Protein.
Time frame: At Month 30
Main Cohort: Absolute Values of Eosinophils and Neutrophils at Baseline
Blood samples were collected for the analysis of eosinophils and neutrophils. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.
Time frame: At Baseline (Day 1 of Month 1)
Main Cohort: Absolute Values of Eosinophils and Neutrophils at Month 30
Blood samples were collected for the analysis of eosinophils and neutrophils.
Time frame: At Month 30
Main Cohort: Absolute Values of Hemoglobin at Baseline
Blood samples were collected for the analysis of hemoglobin. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.
Time frame: At Baseline (Day 1 of Month 1)
Main Cohort: Absolute Values of Hemoglobin at Months 30
Blood samples were collected for the analysis of hemoglobin.
Time frame: At Month 30
Sub-cohort: Absolute Values of Serum Interferon-gamma-inducible Protein -10 (IP-10) and Serum Soluble Receptor for Advanced Glycation End Products (sRAGE) at Baseline
Blood samples were collected at Baseline for the analysis of blood biomarkers serum IP-10 and serum sRAGE. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.
Time frame: At Baseline (Day 1 of Month 1)
Sub-cohort: Absolute Values of Serum IP-10 and Serum sRAGE at Month 30
Blood samples were collected at Month 30 for the analysis of blood biomarkers serum IP-10 and serum sRAGE.
Time frame: At Month 30
Sub-cohort: Absolute Values of Club Cell Protein (CC16) at Baseline
Blood samples were collected for the analysis of blood biomarker CC16. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.
Time frame: At Baseline (Day 1 of Month 1)
Sub-cohort: Absolute Values of CC16 at Month 30
Blood samples were collected for the analysis of blood biomarker CC16.
Time frame: At Month 30
Sub-cohort: Absolute Values of Glycated Hemoglobin A1c (HbA1c) at Baseline
Blood samples were collected for the analysis of HbA1c. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.
Time frame: At Baseline (Day 1 of Month 1)
Sub-cohort: Absolute Values of HbA1c at Month 30
Blood samples were collected for the analysis of HbA1c.
Time frame: At Month 30
Sub-cohort: Sputum Microbiome as Assessed by Molecular Methods
Sputum microbiome evaluation involves extraction of deoxyribonucleic acid from sputum samples and analyzing it to identify the microbial community present in the samples using molecular methods. There were not enough samples for analysis. Consequently, data was not analyzed, and data will never be analyzed for this outcome measure in the future.
Time frame: Up to 30 months
Sub-cohort: Absolute Values of Total Cell Count of Sputum Sample at Baseline
Sputum samples were collected from the participants for assessment of total cell count. Baseline value was the assessment with a non-missing value at Day 1 of Month 1. Data was not collected for "Never Smoker Healthy Control" arm as sputum samples were not collected at Baseline visit for healthy control group as per the Protocol.
Time frame: At Baseline (Day 1 of Month 1)
Sub-cohort: Absolute Values of Total Cell Count of Sputum Sample at Month 30
Sputum samples were collected from the participants for assessment of total cell count.
Time frame: At Month 30
Main Cohort: Number of Participants With COPD Medication
Number of participants with COPD medications received have been presented in separate categories. Data was collected in following categories: Naïve, long-acting muscarinic antagonist (LAMA), long-acting beta agonist (LABA), inhaled corticosteroid (ICS)/LABA, LAMA/LABA, Triple (open), and Triple (closed).
Time frame: Up to 30 months
Main Cohort: Number of Participants With Change From Baseline in Treatment Pattern
Data was collected in following categories: Step-up (the treatment pattern grade become larger than previous visit), Switch (the treatment pattern changed within a same grade (except grade 0), Stable (the treatment pattern remain the same (except grade 0), Step-down (participants receive treatment and the grade goes down compared with the previous visit), Stop/Missing (No treatment record in the period), and Naïve with respect to their treatment received. Baseline value was the assessment with a non-missing value at Day 1 of Month 1. Number of participants with change from Baseline in treatment pattern have been presented.
Time frame: Baseline (Day 1 of Month 1) and Month 30
Number of Participants With COPD Related Outpatient Visits
Number of participants with COPD related outpatient visits have been presented.
Time frame: Up to 30 months
Number of Participants With Non-COPD Related Outpatient Visits
Number of participants with non-COPD related outpatient visits have been presented.
Time frame: Up to 30 months
Number of Participants With COPD Related Emergency Visits
Number of participants with COPD related emergency visits have been presented.
Time frame: Up to 30 months
Number of Participants With Non-COPD Related Emergency Visits
Number of participants with non-COPD related emergency visits have been presented.
Time frame: Up to 30 months
Number of Participants With COPD Related Hospitalizations Visits
Number of participants with COPD related hospitalizations visits have been presented.
Time frame: Up to 30 months
Number of Participants With Non-COPD Related Hospitalizations Visits
Number of participants with non-COPD related hospitalizations visits have been presented.
Time frame: Up to 30 months
Direct Medical Costs Associated With COPD Medications During Study Period
Direct medical costs of out-of-pocket payment and basic insurance were included for following items: Hospital, Outpatient, Emergency, Participant check, Participant therapy and Prescribing costs.
Time frame: Up to 30 months
Sub-cohort: Absolute Values of Airway Wall Area at Baseline
Airway wall area, in ratio, at Baseline is calculated by dividing airway wall area by total airway area, using low-dose high-resolution computed tomography (HRCT) acquired at Baseline. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.
Time frame: Baseline (Day 1 of Month 1)
Sub-cohort: Absolute Values of Airway Wall Area at Month 30
Airway wall area, in ratio, at Month 30 is calculated by dividing airway wall area by total airway area, using low-dose HRCT acquired at Month 30.
Time frame: At Month 30
Sub-cohort: Average of Airway Major Inner Diameter at Baseline
Average of airway major inner diameter at Baseline is the averaged longest axis of the airway's cross-section in low-dose HRCT acquired at Baseline. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.
Time frame: Baseline (Day 1 of Month 1)
Sub-cohort: Average of Airway Major Inner Diameter at Month 30
Average of airway major inner diameter at Month 30 is the averaged longest axis of the airway's cross-section in low-dose HRCT acquired at Month 30.
Time frame: At Month 30
Sub-cohort: Average of Airway Minor Inner Diameter at Baseline
Average of airway minor inner diameter at Baseline is the averaged shortest axis of the airway's cross-section in low-dose high-resolution Computed Tomography (HRCT) acquired at Baseline. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.
Time frame: Baseline (Day 1 of Month 1)
Sub-cohort: Average of Airway Minor Inner Diameter at Month 30
Average of airway minor inner diameter at Month 30 is the averaged shortest axis of the airway's cross-section in low-dose HRCT acquired at Month 30.
Time frame: At Month 30
Sub-cohort: Total Airway Count at Baseline
Total airway count at Baseline is derived by summing the number of airway segments identified on low-dose HRCT acquired at Baseline. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.
Time frame: Baseline (Day 1 of Month 1)
Sub-cohort: Total Airway Count at Month 30
Total airway count at Month 30 is derived by summing the number of airway segments identified on low-dose HRCT acquired at Month 30.
Time frame: At Month 30
Sub-cohort: Absolute Values of Perimeter of 10 Millimeter (mm) (Pi10) at Baseline
Pi10 at Baseline is a measure of airway wall thickness, which is calculated by the square root of wall area for a theoretical airway with an internal perimeter of 10 millimeter, using low-dose HRCT acquired at Baseline. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.
Time frame: Baseline (Day 1 of Month 1)
Sub-cohort: Absolute Values of Pi10 at Month 30
Pi10 at Month 30 is a measure of airway wall thickness, which is calculated by the square root of wall area for a theoretical airway with an internal perimeter of 10 millimeter, using low-dose HRCT acquired at Month 30.
Time frame: At Month 30
Sub-cohort: Computed Tomography (CT) Attenuation at the 15th Percentile of the Lung CT Histogram (Perc15) in Residual Volume at Baseline
Perc15 in residual volume (RV) at Baseline is the cut-off value, in Hounsfield Unit (HU), below which are distributed the 15 percent of the voxels with the lowest density in low-dose HRCT, acquired at full expiration at Baseline. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.
Time frame: Baseline (Day 1 of Month 1)
Sub-cohort: Perc15 in Residual Volume at Month 30
Perc15 in residual volume (RV) at Month 30 is the cut-off value, in Hounsfield Unit (HU), below which are distributed the 15 percent of the voxels with the lowest density in low-dose HRCT, acquired at full expiration at Month 30.
Time frame: At Month 30
Sub-cohort: Perc15 in Total Lung Capacity at Baseline
Perc15 in total lung capacity (TLC) at Baseline is the cut-off value, in Hounsfield Unit (HU), below which are distributed the 15 percent of the voxels with the lowest density in low-dose HRCT, acquired at full inspiration at Baseline. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.
Time frame: Baseline (Day 1 of Month 1)
Sub-cohort: Perc15 in Total Lung Capacity at Month 30
Perc15 in total lung capacity (TLC) at Month 30 is the cut-off value, in Hounsfield Unit (HU), below which are distributed the 15 percent of the voxels with the lowest density in low-dose HRCT, acquired at full inspiration at Month 30.
Time frame: At Month 30
Sub-cohort: Absolute Values of Low Attenuation Area -950 (LAA-950) at Baseline
LAA-950 at Baseline is percentage (%) of voxels with attenuation less than or equal to (\<=)-950 Hounsfield Unit (HU), which is associated with the extent of emphysema, computed using low-dose HRCT acquired at Baseline. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.
Time frame: Baseline (Day 1 of Month 1)
Sub-cohort: Absolute Values of LAA-950 at Month 30
LAA-950 at Month 30 is percentage (%) of voxels with attenuation \<=-950 Hounsfield Unit (HU), which is associated with the extent of emphysema, computed using low-dose HRCT acquired at Month 30.
Time frame: At Month 30
Sub-cohort: Absolute Values of Disease Probability Measure (DPM) to Assess Gas Trapping at Baseline
Percentage of whole lung associated with gas trapping (GT) as measured by DPM at Baseline. DPM uses low-dose HRCT acquired at both full inspiration (total lung capacity \[TLC\]) and full expiration (residual volume \[RV\]) for calculating the percentage of lung volume associated with gas trapping. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.
Time frame: Baseline (Day 1 of Month 1)
Sub-cohort: Absolute Values of DPM to Assess Gas Trapping at Month 30
Percentage of whole lung associated with gas trapping (GT) as measured by DPM at Week 30. DPM uses low-dose HRCT acquired at both full inspiration (total lung capacity \[TLC\]) and full expiration (residual volume \[RV\]) for calculating the percentage of lung volume associated with gas trapping.
Time frame: At Month 30
Sub-cohort: Absolute Values of DPM to Assess Emphysema at Baseline
Percentage of whole lung associated with emphysema as measured by DPM at Baseline. DPM uses low-dose HRCT acquired at both full inspiration (total lung capacity \[TLC\]) and full expiration (residual volume \[RV\]) for calculating the percentage of lung volume associated with emphysema. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.
Time frame: Baseline (Day 1 of Month 1)
Sub-cohort: Absolute Values of DPM to Assess Emphysema at Month 30
Percentage of whole lung associated with emphysema as measured by DPM at Month 30. DPM uses low-dose HRCT acquired at both full inspiration (total lung capacity \[TLC\]) and full expiration (residual volume \[RV\]) for calculating the percentage of lung volume associated with emphysema.
Time frame: At Month 30
Sub-cohort: Absolute Values of DPM to Assess Normal Tissue at Baseline
Percentage of whole lung associated with normal tissue (NT) as measured by DPM at Baseline. DPM uses low-dose HRCT acquired at both full inspiration (total lung capacity \[TLC\]) and full expiration (residual volume \[RV\]) for calculating the percentage of lung volume associated with normal tissue. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.
Time frame: Baseline (Day 1 of Month 1)
Sub-cohort: Absolute Values of DPM to Assess Normal Tissue at Month 30
Percentage of whole lung associated with normal tissue (NT) as measured by DPM at Month 30. DPM uses low-dose HRCT acquired at both full inspiration (total lung capacity \[TLC\]) and full expiration (residual volume \[RV\]) for calculating the percentage of lung volume associated with normal tissue.
Time frame: At Month 30
Sub-cohort: Air Volume Ratio (RV/TLC) at Baseline
Air volume ratio at Baseline is defined as air volume at full expiration (FE) (residual volume \[RV\]) divided by air volume at full inspiration (FI) (total lung capacity \[TLC\]) multiplied by 100 (expressed as percentage), measured using low-dose HRCT acquired at Baseline. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.
Time frame: Baseline (Day 1 of Month 1)
Sub-cohort: Air Volume Ratio (RV/TLC) at Month 30
Air volume ratio at Month 30 is defined as air volume at full expiration (FE) (residual volume \[RV\]) divided by air volume at full inspiration (FI) (total lung capacity \[TLC\]) multiplied by 100 (expressed as percentage), measured using low-dose HRCT acquired at Month 30.
Time frame: At Month 30
| Milestone | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|
| Started | 1698 | 184 | 123 |
| Full population | 1696 | 184 | 123 |
| Completed | 1451 | 165 | 116 |
| Not completed | 247 | 19 | 7 |
| Withdrew: Withdrawal by subject | 81 | 4 | 1 |
| Withdrew: Physician decision | 12 | 4 | 1 |
| Withdrew: Lost to follow-up | 50 | 0 | 0 |
| Withdrew: Other | 102 | 11 | 5 |
| Withdrew: Not included in the full population due to investigator discretion | 1 | 0 | 0 |
| Withdrew: Not included in the full population due to withdrew consent | 1 | 0 | 0 |
Moderate exacerbations are defined as COPD exacerbations that require either systemic corticosteroids (intramuscular, intravenous, or oral) and/or antibiotics. Severe exacerbations are defined as COPD exacerbations requiring hospitalization (including intubation and admittance to an intensive care unit) or result in death. Exacerbation rate = number of moderate or sever exacerbation divided by total participants-years. Analysis performed using a generalized linear model assuming a negative binomial distribution with covariates of type of participants (i.e. GOLD I-IV and chronic bronchitis), gender, smoking status, exacerbation history (moderate/severe), site (type of hospital), maintenance therapy (Y/N) and inhaled corticosteroid (ICS) containing (Y/N), Childhood chest disease (Y/N) and biomass fuel exposure (Y/N), age, and with offset logarithm of time on study.
| Exacerbations per participant per year | Participants With COPD - GOLD Grade I | Participants With COPD - GOLD Grade II | Participants With COPD - GOLD Grade III | Participants With COPD - GOLD Grade IV | Participants With Chronic Bronchitis |
|---|---|---|---|---|---|
| Main Cohort: Rate of Moderate/Severe Exacerbations in COPD and Chronic Bronchitis Cohorts | 0.08 (0.06 to 0.10) | 0.12 (0.11 to 0.14) | 0.26 (0.21 to 0.33) | 0.35 (0.25 to 0.49) | 0.02 (0.01 to 0.04) |
The CAT is a validated 8-items questionnaire developed for use in routine clinical practice to measure the health status of participants with COPD. Participants rate their experience on a 6-point scale, ranging from 0 (no impairment) to 5 (maximum impairment), higher score indicates greater impairment. A total CAT score was calculated by summing the non-missing scores of the eight items with a scoring range of 0 (no disease impact) to 40 (maximum disease impact). Higher scores indicated greater disease impact. Baseline value was the assessment with a non-missing value at Day 1 of Month 1. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
| Scores on a scale | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|
| Main Cohort: Change From Baseline in COPD Assessment Test (CAT) Score at Month 30 | -0.9 ± 5.84 | -2.3 ± 5.45 | 0.3 ± 2.46 |
The CAT is a validated 8-items questionnaire developed for use in routine clinical practice to measure the health status of participants with COPD. Participants rate their experience on a 6-point scale, ranging from 0 (no impairment) to 5 (maximum impairment), higher score indicates greater impairment. A total CAT score was calculated by summing the non-missing scores of the eight items with a scoring range of 0 (no disease impact) to 40 (maximum disease impact). Higher scores indicated greater disease impact.
| Scores on a scale | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|
| Main Cohort: Absolute Values of CAT Score at Month 30 | 7.5 ± 5.33 | 5.7 ± 4.18 | 1.3 ± 2.36 |
The CATPURE is a short, five-item questionnaire that can be easily completed by participants and are used to identify individuals who may have undiagnosed, clinically significant COPD. The algorithm is a simple summation of participants responses to each of the five items. For Question 1-4: Score 0 for 'No' and Score 1 for 'Yes'; Question 5: Score 0 for 'None', 1 for 'Once' and 2 for '2 or more'. Total score is ranging from 0 to 6, higher score means higher risk of COPD (0-1 is at low risk, 2-6 is at high risk). Baseline value was the assessment with a non-missing value at Day 1 of Month 1.
| Scores on a scale | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|
| Main Cohort: Total Score of COPD Assessment in Primary Care to Identify Undiagnosed Respiratory Disease and Exacerbation Risk (CAPTURE) at Baseline | 2.6 ± 1.48 | 2.0 ± 1.37 | 0.3 ± 0.55 |
The CATPURE is a short, five-item questionnaire that can be easily completed by participants and are used to identify individuals who may have undiagnosed, clinically significant COPD. The algorithm is a simple summation of participants responses to each of the five items. For Question 1-4: Score 0 for 'No' and Score 1 for 'Yes'; Question 5: Score 0 for 'None', 1 for 'Once' and 2 for '2 or more'. Total score is ranging from 0 to 6, higher score means higher risk of COPD (0-1 is at low risk, 2-6 is at high risk).
| Scores on a scale | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|
| Main Cohort: Total Score of CAPTURE at Month 18 | 2.5 ± 1.48 | 1.8 ± 1.49 | 0.4 ± 0.69 |
CID was defined as decrease of greater than or equal to (\>=) 100 milliliter (mL) in post-bronchodilator FEV1 or increase of \>=2 units in the CAT, or an occurrence of a moderate/severe exacerbation. CID was derived from three key clinical assessments: 1. moderate/severe exacerbations, 2. worsening of FEV1, and 3. worsening of health status using the CAT questionnaire. Baseline value was the assessment with a non-missing value at Day 1 of Month 1. A participant may have more than one CID components, hence total of participants with individual CID components may not match with participants with 'Any CID' category. Number of participants with any CID event and its components (Exacerbation CID, FEV1 CID and CAT CID) observed from Baseline to Month 6 have been presented.
| Participants | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|
| Any CID | 897 | 90 | 58 |
| Exacerbation CID | 153 | 1 | 0 |
| FEV1 CID | 431 | 55 | 36 |
| CAT CID | 567 | 53 | 31 |
CID was defined as: decrease of greater than or equal to (\>=) 100 milliliter (mL) in post-bronchodilator FEV1 or increase of \>=2 units in the CAT, or an occurrence of a moderate/severe exacerbation. CID was derived from three key clinical assessments: 1. moderate/severe exacerbations, 2. worsening of FEV1, and 3. worsening of health status using the CAT questionnaire. A participant may have more than one CID components, hence total of participants with individual CID components may not match with participants with 'Any CID' category. Number of participants with any CID event and its components (Exacerbation CID, FEV1 CID and CAT CID) observed from Months 6 to 18 have been presented.
| Participants | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|
| Any CID | 1120 | 97 | 82 |
| Exacerbation CID | 211 | 0 | 0 |
| FEV1 CID | 524 | 64 | 42 |
| CAT CID | 794 | 52 | 60 |
CID was defined as: decrease of greater than or equal to (\>=) 100 milliliter (mL) in post-bronchodilator FEV1 or increase of \>=2 units in the CAT, or an occurrence of a moderate/severe exacerbation. CID was derived from three key clinical assessments: 1. moderate/severe exacerbations, 2. worsening of FEV1, and 3. worsening of health status using the CAT questionnaire. A participant may have more than one CID components, hence total of participants with individual CID components may not match with participants with 'Any CID' category. Number of participants with any CID event and its components (Exacerbation CID, FEV1 CID and CAT CID) observed from Months 18 to 30 have been presented.
| Participants | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|
| Any CID | 1086 | 93 | 68 |
| Exacerbation CID | 177 | 2 | 0 |
| FEV1 CID | 594 | 61 | 37 |
| CAT CID | 771 | 54 | 48 |
Number of participants who died during study have been presented.
| Participants | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|
| Main Cohort: Number of Participants Who Died | 41 | 2 | 0 |
E-RS: COPD is a subset of Exacerbations of Chronic pulmonary Disease Tool (EXACT). E-RS: COPD is a tool that consists of 11 items from the 14 item EXACT instrument. The domains include: respiratory symptoms-breathlessness (RS-BRL) comprised of 5 items (2 items scored from 0-4 and 3 items scored from 0-3); RS-cough and sputum (RS-CSP) comprised of 3 items(2 items scored from 0-4 and 1 item scored from 0-3);and RS-chest symptoms (RS-CSY) comprised of 3 items (scored from 0-4). The total score was calculated by taking sum of all individual 11 item scores, which ranges between 0-40 and higher score indicates more severe symptoms. Baseline value was the assessment with a non-missing value at Day 1 of Month 1. The 1 to 6 month E-RS:COPD total score value was derived by calculating the average of E-RS:COPD total scores collected between month 1 and 6. Change from Baseline was calculated by subtracting Baseline value from 1-6 month average total score value.
| Scores on a scale | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|
| Sub-cohort: Change From Baseline in Evaluating Respiratory Symptoms in COPD (E-RS:COPD) Total Scores From Months 1 to 6 | 0.697 ± 3.6181 | -0.018 ± 2.8032 | 0.020 ± 1.2256 |
E-RS: COPD is a subset of Exacerbations of Chronic pulmonary Disease Tool (EXACT). E-RS: COPD is a tool that consists of 11 items from the 14 item EXACT instrument. The domains include: respiratory symptoms-breathlessness (RS-BRL) comprised of 5 items (2 items scored from 0-4 and 3 items scored from 0-3); RS-cough and sputum (RS-CSP) comprised of 3 items(2 items scored from 0-4 and 1 item scored from 0-3);and RS-chest symptoms (RS-CSY) comprised of 3 items (scored from 0-4). The total score was calculated by taking sum of all individual 11 item scores, which ranges between 0-40 and higher score indicates more severe symptoms. Baseline value was the assessment with a non-missing value at Day 1 of Month 1. The 18 to 24 month E-RS:COPD total score value was derived by calculating the average of E-RS:COPD total scores collected between month 18 and 24. Change from Baseline was calculated by subtracting Baseline value from 18-24 month average total score value.
| Scores on a scale | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|
| Sub-cohort: Change From Baseline in E-RS:COPD Total Scores From Months 18 to 24 | 1.735 ± 4.6876 | 1.014 ± 4.3033 | 0.086 ± 1.3097 |
The EXACT is a 14-item daily diary designed to provide a measure of patient-reported symptoms of COPD exacerbation. An EXACT Total Score, ranging from 0 to 100, where higher scores indicate a more severe condition. EXACT events were defined as magnitude of responder for symptomatic events defined as acute, sustained symptomatic worsening of COPD, defined as an increase in EXACT score \>=9 points for 3 days or \>=12 points for 2 days, above Baseline (Baseline value is average of 7-day period \[Day 1 to 7\]). Number of participants with EXACT events observed from Months 1 to 6 have been presented.
| Participants | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|
| Sub-cohort: Number of Participants With Exacerbation of COPD Tool (EXACT) Events From Months 1 to 6 | 59 | 12 | 1 |
The EXACT is a 14-item daily diary designed to provide a measure of patient-reported symptoms of COPD exacerbation. An EXACT Total Score, ranging from 0 to 100, where higher scores indicate a more severe condition. EXACT events were defined as magnitude of responder for symptomatic events defined as acute, sustained symptomatic worsening of COPD, defined as an increase in EXACT score \>=9 points for 3 days or \>=12 points for 2 days, above Baseline (Baseline value is average of 7-day period \[Day 1 to 7\]). Number of participants with EXACT events observed from Months 18 to 24 have been presented.
| Participants | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|
| Sub-cohort: Number of Participants With EXACT Events From Months 18 to 24 | 55 | 13 | 0 |
Digital physical activity was evaluated by daily steps as assessed by a wrist band dispensed at Baseline. Participants were required to keep wearing the wrist band. The daily step data was based on the daily average steps (steps per day) for each participant. Baseline value was derived as the average value of first 7 days (Days 1 to 7 at Month 1).
| Steps per day | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|
| Sub-cohort: Absolute Values of Digital Physical Activity at Baseline (Average of Days 1 to 7) | 7986.2 ± 3433.46 | 8743.2 ± 3750.53 | 12063.6 ± 4152.42 |
Digital physical activity was evaluated by daily steps as assessed by a wrist band dispensed at Baseline. Participants were required to keep wearing the wrist band. The daily step data was based on the daily average steps (steps per day) for each participant. Month 1 value was derived as the average of daily step data up to 30 days from study Day 8.
| Steps per day | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|
| Sub-cohort: Absolute Values of Digital Physical Activity at Month 1 (Average of Day 8 to Month 1) | 8461.3 ± 3750.31 | 9284.5 ± 4011.25 | 12790.5 ± 4233.32 |
Digital physical activity was evaluated by daily steps as assessed by a wrist band dispensed at Baseline. Participants were required to keep wearing the wrist band. The daily step data was based on the daily average steps (steps per day) for each participant. Month 18 value was derived as the average of daily step data up to 30 days from Month 18.
| Steps per day | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|
| Sub-cohort: Absolute Values of Digital Physical Activity at Month 18 (Average of Months 18 to 19) | 6138.3 ± 3664.12 | 6454.3 ± 3207.73 | 7495.4 ± 4723.39 |
Fibrinogen is a protein, specifically a clotting factor (factor I), that is essential for proper blood clot formation. Blood samples were collected to evaluate the amount of fibrinogen. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.
| Milligram per deciliter | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|
| Main Cohort: Absolute Values of Plasma Fibrinogen at Baseline | 337.1 ± 82.59 | 315.8 ± 89.97 | 304.4 ± 73.36 |
Fibrinogen is a protein, specifically a clotting factor (factor I), that is essential for proper blood clot formation. Blood samples were collected to evaluate the amount of fibrinogen.
| Milligram per deciliter | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|
| Main Cohort: Absolute Values of Plasma Fibrinogen at Month 30 | 341.2 ± 82.94 | 328.4 ± 66.10 | 315.9 ± 63.01 |
Blood samples were collected for the analysis of C-Reactive Protein. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.
| Milligram per deciliter | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|
| Main Cohort: Absolute Values of C-Reactive Protein at Baseline | 0.2791 ± 0.68530 | 0.2463 ± 0.93353 | 0.1654 ± 0.40848 |
Blood samples were collected for the analysis of C-Reactive Protein.
| Milligram per deciliter | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|
| Main Cohort: Absolute Values of C-Reactive Protein at Month 30 | 0.3411 ± 0.71558 | 0.2734 ± 0.63660 | 0.1645 ± 0.20928 |
Blood samples were collected for the analysis of eosinophils and neutrophils. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.
| Giga cells per liter | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|
| Eosinophils | 0.231 ± 0.2084 | 0.199 ± 0.1711 | 0.109 ± 0.1006 |
| Neutrophils | 4.467 ± 1.6253 | 4.180 ± 1.5366 | 3.810 ± 0.9967 |
Blood samples were collected for the analysis of eosinophils and neutrophils.
| Giga cells per liter | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|
| Eosinophils | 0.267 ± 0.2921 | 0.228 ± 0.2351 | 0.145 ± 0.1853 |
| Neutrophils | 4.516 ± 1.6207 | 4.198 ± 1.6725 | 3.667 ± 1.0537 |
Blood samples were collected for the analysis of hemoglobin. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.
| Grams per liter | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|
| Main Cohort: Absolute Values of Hemoglobin at Baseline | 142.2 ± 13.03 | 141.6 ± 11.90 | 132.7 ± 15.03 |
Blood samples were collected for the analysis of hemoglobin.
| Grams per liter | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|
| Main Cohort: Absolute Values of Hemoglobin at Months 30 | 143.4 ± 13.50 | 144.3 ± 12.29 | 135.3 ± 12.97 |
Blood samples were collected at Baseline for the analysis of blood biomarkers serum IP-10 and serum sRAGE. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.
| Picogram per milliliter | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|
| Serum IP-10 | 41.193 ± 45.1502 | 36.025 ± 34.8718 | 48.524 ± 50.1930 |
| Serum sRAGE | 907.135 ± 506.1643 | 993.892 ± 655.1966 | 1101.124 ± 551.8240 |
Blood samples were collected at Month 30 for the analysis of blood biomarkers serum IP-10 and serum sRAGE.
| Picogram per milliliter | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|
| Serum IP-10 | 54.435 ± 83.4309 | 53.711 ± 51.1595 | 35.103 ± 20.8046 |
| Serum sRAGE | 1046.746 ± 632.6992 | 1287.528 ± 905.2041 | 1166.739 ± 608.9050 |
Blood samples were collected for the analysis of blood biomarker CC16. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.
| Nanogram per milliliter | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|
| Sub-cohort: Absolute Values of Club Cell Protein (CC16) at Baseline | 8.8512 ± 6.80359 | 9.2704 ± 7.29006 | 7.8313 ± 5.76284 |
Blood samples were collected for the analysis of blood biomarker CC16.
| Nanogram per milliliter | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|
| Sub-cohort: Absolute Values of CC16 at Month 30 | 15.2812 ± 10.90814 | 15.5412 ± 10.78253 | 14.4739 ± 8.45046 |
Blood samples were collected for the analysis of HbA1c. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.
| Percentage of HbA1c in blood | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|
| Sub-cohort: Absolute Values of Glycated Hemoglobin A1c (HbA1c) at Baseline | 5.68 ± 0.660 | 5.87 ± 0.989 | 5.66 ± 0.901 |
Blood samples were collected for the analysis of HbA1c.
| Percentage of HbA1c in blood | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|
| Sub-cohort: Absolute Values of HbA1c at Month 30 | 5.74 ± 0.754 | 5.99 ± 1.227 | 5.83 ± 0.739 |
Sputum microbiome evaluation involves extraction of deoxyribonucleic acid from sputum samples and analyzing it to identify the microbial community present in the samples using molecular methods. There were not enough samples for analysis. Consequently, data was not analyzed, and data will never be analyzed for this outcome measure in the future.
No measurements were reported for this outcome.
Sputum samples were collected from the participants for assessment of total cell count. Baseline value was the assessment with a non-missing value at Day 1 of Month 1. Data was not collected for "Never Smoker Healthy Control" arm as sputum samples were not collected at Baseline visit for healthy control group as per the Protocol.
| Cells per milliliter | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|
| Sub-cohort: Absolute Values of Total Cell Count of Sputum Sample at Baseline | 545.981 ± 379.7851 | 529.603 ± 611.6267 | — |
Sputum samples were collected from the participants for assessment of total cell count.
| Cells per milliliter | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|
| Sub-cohort: Absolute Values of Total Cell Count of Sputum Sample at Month 30 | 766.888 ± 1005.4170 | 550.053 ± 557.1129 | 835.903 ± 511.9084 |
Number of participants with COPD medications received have been presented in separate categories. Data was collected in following categories: Naïve, long-acting muscarinic antagonist (LAMA), long-acting beta agonist (LABA), inhaled corticosteroid (ICS)/LABA, LAMA/LABA, Triple (open), and Triple (closed).
| Participants | All Participants |
|---|---|
| Naive | 1649 |
| LAMA | 102 |
| LABA | 8 |
| ICS/LABA | 115 |
| LAMA/LABA | 77 |
| Triple (open) | 19 |
| Triple (closed) | 33 |
Data was collected in following categories: Step-up (the treatment pattern grade become larger than previous visit), Switch (the treatment pattern changed within a same grade (except grade 0), Stable (the treatment pattern remain the same (except grade 0), Step-down (participants receive treatment and the grade goes down compared with the previous visit), Stop/Missing (No treatment record in the period), and Naïve with respect to their treatment received. Baseline value was the assessment with a non-missing value at Day 1 of Month 1. Number of participants with change from Baseline in treatment pattern have been presented.
| Participants | All Participants |
|---|---|
| Step-up | 104 |
| Switch | 0 |
| Stable | 32 |
| Step-down | 10 |
| Stop/Missing | 309 |
| Naive | 1548 |
Number of participants with COPD related outpatient visits have been presented.
| Participants | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|
| Number of Participants With COPD Related Outpatient Visits | 1240 | 50 | 3 |
Number of participants with non-COPD related outpatient visits have been presented.
| Participants | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|
| Number of Participants With Non-COPD Related Outpatient Visits | 0 | 0 | 0 |
Number of participants with COPD related emergency visits have been presented.
| Participants | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|
| Number of Participants With COPD Related Emergency Visits | 185 | 5 | 0 |
Number of participants with non-COPD related emergency visits have been presented.
| Participants | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|
| Number of Participants With Non-COPD Related Emergency Visits | 291 | 32 | 24 |
Number of participants with COPD related hospitalizations visits have been presented.
| Participants | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|
| Number of Participants With COPD Related Hospitalizations Visits | 276 | 6 | 0 |
Number of participants with non-COPD related hospitalizations visits have been presented.
| Participants | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|
| Number of Participants With Non-COPD Related Hospitalizations Visits | 0 | 0 | 0 |
Direct medical costs of out-of-pocket payment and basic insurance were included for following items: Hospital, Outpatient, Emergency, Participant check, Participant therapy and Prescribing costs.
| Chinese Yuan | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|
| Out-of-pocket payment: Hospital | 25416.68 ± 29042.578 | — | — |
| Basic Insurance: Hospital | 20069.34 ± 20912.555 | 9637.41 ± 3660.536 | — |
| Out-of-pocket payment: Outpatient | 2088.99 ± 3896.868 | 1105.52 ± 1447.270 | 58.00 ± NA |
| Basic Insurance: Outpatient | 5254.15 ± 5051.381 | 1773.34 ± 2593.387 | 268.00 ± 294.156 |
| Out-of-pocket payment: Emergency | 962.12 ± 1354.719 | 430.46 ± 190.164 | — |
| Basic Insurance: Emergency | 1016.38 ± 1054.997 | 102.58 ± 119.607 | — |
| Out-of-pocket payment: Participant check | 1138.82 ± 2936.166 | 543.96 ± 368.125 | 58.00 ± NA |
| Basic Insurance: Participant check | 3447.89 ± 4982.828 | 2191.53 ± 2314.739 | 60.00 ± NA |
| Out-of-pocket payment: Participant therapy | 1177.49 ± 5938.384 | 68.26 ± 155.206 | — |
| Basic Insurance: Participant therapy | 3052.55 ± 5819.362 | 1014.96 ± 1381.025 | 17.00 ± NA |
| Out-of-pocket payment: Prescribing costs | 2468.19 ± 4715.511 | 1458.08 ± 1744.227 | — |
| Basic Insurance: Prescribing costs | 6330.98 ± 6999.658 | 1747.48 ± 2348.413 | 459.00 ± NA |
Airway wall area, in ratio, at Baseline is calculated by dividing airway wall area by total airway area, using low-dose high-resolution computed tomography (HRCT) acquired at Baseline. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.
| Ratio | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|
| Sub-cohort: Absolute Values of Airway Wall Area at Baseline | 0.630 ± 0.0408 | 0.623 ± 0.0335 | 0.631 ± 0.0321 |
Airway wall area, in ratio, at Month 30 is calculated by dividing airway wall area by total airway area, using low-dose HRCT acquired at Month 30.
| Ratio | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|
| Sub-cohort: Absolute Values of Airway Wall Area at Month 30 | 0.628 ± 0.0533 | 0.627 ± 0.0384 | 0.639 ± 0.0364 |
Average of airway major inner diameter at Baseline is the averaged longest axis of the airway's cross-section in low-dose HRCT acquired at Baseline. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.
| Millimeter | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|
| Sub-cohort: Average of Airway Major Inner Diameter at Baseline | 5.505 ± 0.9841 | 5.619 ± 0.7687 | 5.301 ± 0.8259 |
Average of airway major inner diameter at Month 30 is the averaged longest axis of the airway's cross-section in low-dose HRCT acquired at Month 30.
| Millimeter | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|
| Sub-cohort: Average of Airway Major Inner Diameter at Month 30 | 5.371 ± 0.8963 | 5.536 ± 0.8258 | 5.128 ± 1.0098 |
Average of airway minor inner diameter at Baseline is the averaged shortest axis of the airway's cross-section in low-dose high-resolution Computed Tomography (HRCT) acquired at Baseline. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.
| Millimeter | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|
| Sub-cohort: Average of Airway Minor Inner Diameter at Baseline | 4.058 ± 0.6732 | 4.222 ± 0.6050 | 3.973 ± 0.5335 |
Average of airway minor inner diameter at Month 30 is the averaged shortest axis of the airway's cross-section in low-dose HRCT acquired at Month 30.
| Millimeter | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|
| Sub-cohort: Average of Airway Minor Inner Diameter at Month 30 | 3.969 ± 0.6694 | 4.174 ± 0.6569 | 3.804 ± 0.5863 |
Total airway count at Baseline is derived by summing the number of airway segments identified on low-dose HRCT acquired at Baseline. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.
| Airway Segments | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|
| Sub-cohort: Total Airway Count at Baseline | 353.5 ± 123.77 | 430.9 ± 144.01 | 352.0 ± 122.89 |
Total airway count at Month 30 is derived by summing the number of airway segments identified on low-dose HRCT acquired at Month 30.
| Airway Segments | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|
| Sub-cohort: Total Airway Count at Month 30 | 425.8 ± 174.59 | 542.9 ± 183.86 | 392.9 ± 193.63 |
Pi10 at Baseline is a measure of airway wall thickness, which is calculated by the square root of wall area for a theoretical airway with an internal perimeter of 10 millimeter, using low-dose HRCT acquired at Baseline. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.
| Millimeter | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|
| Sub-cohort: Absolute Values of Perimeter of 10 Millimeter (mm) (Pi10) at Baseline | 3.892 ± 0.1361 | 3.917 ± 0.1318 | 3.905 ± 0.1367 |
Pi10 at Month 30 is a measure of airway wall thickness, which is calculated by the square root of wall area for a theoretical airway with an internal perimeter of 10 millimeter, using low-dose HRCT acquired at Month 30.
| Millimeter | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|
| Sub-cohort: Absolute Values of Pi10 at Month 30 | 3.836 ± 0.1571 | 3.860 ± 0.1826 | 3.842 ± 0.1163 |
Perc15 in residual volume (RV) at Baseline is the cut-off value, in Hounsfield Unit (HU), below which are distributed the 15 percent of the voxels with the lowest density in low-dose HRCT, acquired at full expiration at Baseline. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.
| Hounsfield Unit | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|
| Sub-cohort: Computed Tomography (CT) Attenuation at the 15th Percentile of the Lung CT Histogram (Perc15) in Residual Volume at Baseline | -893.654 ± 36.9708 | -829.016 ± 41.3549 | -804.517 ± 41.8978 |
Perc15 in residual volume (RV) at Month 30 is the cut-off value, in Hounsfield Unit (HU), below which are distributed the 15 percent of the voxels with the lowest density in low-dose HRCT, acquired at full expiration at Month 30.
| Hounsfield Unit | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|
| Sub-cohort: Perc15 in Residual Volume at Month 30 | -900.234 ± 35.0697 | -840.501 ± 36.8535 | -825.538 ± 40.4339 |
Perc15 in total lung capacity (TLC) at Baseline is the cut-off value, in Hounsfield Unit (HU), below which are distributed the 15 percent of the voxels with the lowest density in low-dose HRCT, acquired at full inspiration at Baseline. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.
| Hounsfield Unit | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|
| Sub-cohort: Perc15 in Total Lung Capacity at Baseline | -929.370 ± 23.0575 | -903.261 ± 23.9101 | -885.743 ± 22.2715 |
Perc15 in total lung capacity (TLC) at Month 30 is the cut-off value, in Hounsfield Unit (HU), below which are distributed the 15 percent of the voxels with the lowest density in low-dose HRCT, acquired at full inspiration at Month 30.
| Hounsfield Unit | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|
| Sub-cohort: Perc15 in Total Lung Capacity at Month 30 | -933.063 ± 24.9625 | -908.850 ± 20.0450 | -878.913 ± 32.5519 |
LAA-950 at Baseline is percentage (%) of voxels with attenuation less than or equal to (\<=)-950 Hounsfield Unit (HU), which is associated with the extent of emphysema, computed using low-dose HRCT acquired at Baseline. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.
| % of voxels with attenuation <=-950 HU | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|
| Sub-cohort: Absolute Values of Low Attenuation Area -950 (LAA-950) at Baseline | 8.378 ± 8.4787 | 1.707 ± 2.3429 | 0.295 ± 0.3556 |
LAA-950 at Month 30 is percentage (%) of voxels with attenuation \<=-950 Hounsfield Unit (HU), which is associated with the extent of emphysema, computed using low-dose HRCT acquired at Month 30.
| % of voxels with attenuation <=-950 HU | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|
| Sub-cohort: Absolute Values of LAA-950 at Month 30 | 9.765 ± 9.0580 | 1.977 ± 2.0639 | 0.360 ± 0.5297 |
Percentage of whole lung associated with gas trapping (GT) as measured by DPM at Baseline. DPM uses low-dose HRCT acquired at both full inspiration (total lung capacity \[TLC\]) and full expiration (residual volume \[RV\]) for calculating the percentage of lung volume associated with gas trapping. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.
| % of whole lung associated with GT | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|
| Sub-cohort: Absolute Values of Disease Probability Measure (DPM) to Assess Gas Trapping at Baseline | 44.898 ± 17.5307 | 28.978 ± 20.2675 | 24.832 ± 18.2977 |
Percentage of whole lung associated with gas trapping (GT) as measured by DPM at Week 30. DPM uses low-dose HRCT acquired at both full inspiration (total lung capacity \[TLC\]) and full expiration (residual volume \[RV\]) for calculating the percentage of lung volume associated with gas trapping.
| % of whole lung associated with GT | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|
| Sub-cohort: Absolute Values of DPM to Assess Gas Trapping at Month 30 | 43.210 ± 14.2281 | 29.414 ± 16.1524 | 32.157 ± 20.1380 |
Percentage of whole lung associated with emphysema as measured by DPM at Baseline. DPM uses low-dose HRCT acquired at both full inspiration (total lung capacity \[TLC\]) and full expiration (residual volume \[RV\]) for calculating the percentage of lung volume associated with emphysema. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.
| %of whole lung associated with emphysema | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|
| Sub-cohort: Absolute Values of DPM to Assess Emphysema at Baseline | 13.068 ± 12.2280 | 2.402 ± 5.3194 | 0.254 ± 0.5837 |
Percentage of whole lung associated with emphysema as measured by DPM at Month 30. DPM uses low-dose HRCT acquired at both full inspiration (total lung capacity \[TLC\]) and full expiration (residual volume \[RV\]) for calculating the percentage of lung volume associated with emphysema.
| %of whole lung associated with emphysema | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|
| Sub-cohort: Absolute Values of DPM to Assess Emphysema at Month 30 | 15.093 ± 12.4986 | 2.518 ± 3.6730 | 0.877 ± 1.9884 |
Percentage of whole lung associated with normal tissue (NT) as measured by DPM at Baseline. DPM uses low-dose HRCT acquired at both full inspiration (total lung capacity \[TLC\]) and full expiration (residual volume \[RV\]) for calculating the percentage of lung volume associated with normal tissue. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.
| % of whole lung associated with NT | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|
| Sub-cohort: Absolute Values of DPM to Assess Normal Tissue at Baseline | 42.035 ± 20.8647 | 68.620 ± 21.7128 | 74.914 ± 18.3597 |
Percentage of whole lung associated with normal tissue (NT) as measured by DPM at Month 30. DPM uses low-dose HRCT acquired at both full inspiration (total lung capacity \[TLC\]) and full expiration (residual volume \[RV\]) for calculating the percentage of lung volume associated with normal tissue.
| % of whole lung associated with NT | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|
| Sub-cohort: Absolute Values of DPM to Assess Normal Tissue at Month 30 | 41.697 ± 19.2811 | 68.068 ± 17.7974 | 66.966 ± 21.3521 |
Air volume ratio at Baseline is defined as air volume at full expiration (FE) (residual volume \[RV\]) divided by air volume at full inspiration (FI) (total lung capacity \[TLC\]) multiplied by 100 (expressed as percentage), measured using low-dose HRCT acquired at Baseline. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.
| % of air volume at FI remaining after FE | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|
| Sub-cohort: Air Volume Ratio (RV/TLC) at Baseline | 62.821 ± 15.3924 | 48.535 ± 15.5070 | 45.617 ± 13.2394 |
Air volume ratio at Month 30 is defined as air volume at full expiration (FE) (residual volume \[RV\]) divided by air volume at full inspiration (FI) (total lung capacity \[TLC\]) multiplied by 100 (expressed as percentage), measured using low-dose HRCT acquired at Month 30.
| % of air volume at FI remaining after FE | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|
| Sub-cohort: Air Volume Ratio (RV/TLC) at Month 30 | 61.276 ± 12.9739 | 48.906 ± 12.0766 | 51.562 ± 13.4382 |
FEV1 is a measure of lung function and is defined as the volume of air that can be forced out in one second after taking a deep breath. FEV1 was measured electronically by spirometry. Baseline value was the assessment with a non-missing value at Day 1 of Month 1. Change from Baseline was calculated as the value at Month 30 minus the value at Baseline. Change from Baseline in pre- and post-bronchodilator FEV1 was assessed and summarized. Also, yearly rate of change in FEV1 (pre- and post-bronchodilator) was analyzed using random coefficients models.
| Milliliter | Participants With COPD - GOLD Grade I | Participants With COPD - GOLD Grade II | Participants With COPD - GOLD Grade III | Participants With COPD - GOLD Grade IV | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|---|---|---|
| Pre-bronchodilator | -158.9 ± 273.46 | -93.9 ± 271.65 | -1.2 ± 226.44 | -17.3 ± 141.54 | -144.4 ± 250.50 | -53.6 ± 222.51 |
| Post-bronchodilator | -168.1 ± 252.93 | -107.4 ± 250.66 | -34.7 ± 207.13 | -33.6 ± 138.98 | -148.2 ± 229.19 | -77.2 ± 200.51 |
FVC is the total amount of air exhaled during FEV test and is a lung function test that is measured during spirometry. Baseline value was the assessment with a non-missing value at Day 1 of Month 1. Change from Baseline was calculated as the value at Month 30 minus the value at Baseline. Change from Baseline in pre- and post-bronchodilator FVC was assessed and summarized. Also, yearly rate of change in FVC (pre- and post-bronchodilator) was analyzed using random coefficients models.
| Milliliter | Participants With COPD - GOLD Grade I | Participants With COPD - GOLD Grade II | Participants With COPD - GOLD Grade III | Participants With COPD - GOLD Grade IV | Participants With Chronic Bronchitis | Never Smoker Healthy Control |
|---|---|---|---|---|---|---|
| Pre-bronchodilator | -229.2 ± 358.22 | -161.0 ± 351.83 | -58.6 ± 402.70 | -27.3 ± 352.13 | -139.8 ± 302.96 | -26.4 ± 264.49 |
| Post-bronchodilator | -241.7 ± 345.52 | -170.5 ± 332.35 | -115.8 ± 344.63 | -101.6 ± 302.39 | -114.0 ± 273.44 | -81.9 ± 227.64 |
Collected over All-cause mortality was collected up to approximately 30 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| COPD Participants | 41/1,696 (2.4%) | — | — |
| Participants With Chronic Bronchitis | 2/184 (1.1%) | — | — |
| Never Smoker Healthy Control | 0/123 (0%) | — | — |
Baseline Characteristic data are reported for the Full Population which consisted of all participants who were enrolled in the study and attended Visit 1 (Day 1 of Month 1).
| Age, Continuous(Years) | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control | Total |
|---|---|---|---|---|
| Mean | 65.4 ± 7.46 | 61.3 ± 7.16 | 58.7 ± 6.72 | 64.6 ± 7.63 |
| Sex: Female, Male(Participants) | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control | Total |
|---|---|---|---|---|
| Female | 176 | 24 | 82 | 282 |
| Male | 1520 | 160 | 41 | 1721 |
| Race/Ethnicity, Customized(Participants) | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control | Total |
|---|---|---|---|---|
| Asian - East Asian Heritage | 1696 | 184 | 123 | 2003 |
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Pulmonary Disease, Chronic Obstructive →