Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
COPD, Phenotypes, Endotypes, Chronic bronchitis, China, Healthy control
Brief summary
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).
Interventions
Prospective observational cohort study
Sponsors
Guangzhou Institute of Respiratory Health (GIRH)
GlaxoSmithKline
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female participants, aged 50-80 years inclusive. A female is eligible only if she is of non-child bearing potential. * Body mass index (BMI) less than (\<)35. * A signed and dated written informed consent is obtained prior to participation. Additional inclusion criteria for COPD participants: * A Baseline (post-bronchodilator) (FEV1/FVC) ratio \<70 percent (%). * Clinically stable and has no exacerbations for at least 1 month prior to recruitment. * Ever smoker or never smoker. Additional inclusion criteria for chronic bronchitis participants: * Free from other significant diseases. * Baseline post-bronchodilator FEV1/FVC ratio more than (\>)70%. * Chronic bronchitis is defined as at least 3 months of cough and phlegm in a year in the past 2 years. * Clinically stable and has no exacerbations for at least 1 month prior to recruitment. * Ever smoker or never smoker Additional inclusion criteria for healthy participants: * Free from any significant diseases * Baseline post-bronchodilator FEV1/FVC ratio \>70%. * A CAT score \<10. * Never smoker. Passive smoker is not eligible.
Exclusion criteria
* Having undergone lung surgery. * Known respiratory disorders or significant inflammatory disease other than COPD. * Serious, uncontrolled disease (including serious psychological disorders) * Confirmed cancer, unless participants in remission for more than or equal to (\>=)5 years. * Participating or plan to participant in any clinical studies where investigational drugs were tested. * Unable or unwilling to use required digital devices (sub- cohort only). * Have evidence of alcohol or drug abuse. * Have received a blood transfusion in the 4 weeks prior to study start. * On long-term oral corticosteroids. * Unable to walk. * Unable to read and understand Mandarin Chinese. Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Main Cohort: Change From Baseline in Pre-bronchodilator and Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Month 30 | Baseline (Day 1 of Month 1) and 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. |
| Main Cohort: Change From Baseline in Pre-bronchodilator and Post-bronchodilator Forced Vital Capacity (FVC) at Month 30 | Baseline (Day 1 of Month 1) and 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Main Cohort: Absolute Values of CAT Score at Month 30 | 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. |
| Main Cohort: Total Score of COPD Assessment in Primary Care to Identify Undiagnosed Respiratory Disease and Exacerbation Risk (CAPTURE) at Baseline | At Baseline (Day 1 of Month 1) | 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. |
| Main Cohort: Total Score of CAPTURE at Month 18 | 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). |
| Main Cohort: Number of Participants With Any Clinically Important Deterioration (CID) Event and Its Components From Baseline to Month 6 | Baseline (Day 1 of Month 1) 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. |
| Main Cohort: Number of Participants With Any CID Event and Its Components From Months 6 to 18 | 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. |
| Main Cohort: Number of Participants With Any CID Event and Its Components From Months 18 to 30 | 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. |
| Main Cohort: Number of Participants Who Died | Up to 30 months | Number of participants who died during study have been presented. |
| Sub-cohort: Change From Baseline in Evaluating Respiratory Symptoms in COPD (E-RS:COPD) Total Scores From Months 1 to 6 | Baseline (Day 1 of Month 1) and 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. |
| Sub-cohort: Change From Baseline in E-RS:COPD Total Scores From Months 18 to 24 | Baseline (Day 1 of Month 1) and 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. |
| Sub-cohort: Number of Participants With Exacerbation of COPD Tool (EXACT) Events From Months 1 to 6 | 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. |
| Sub-cohort: Number of Participants With EXACT Events From Months 18 to 24 | 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. |
| Sub-cohort: Absolute Values of Digital Physical Activity at Baseline (Average of Days 1 to 7) | At Baseline (Days 1 to 7 at 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. Baseline value was derived as the average value of first 7 days (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) | Up to 30 days from study Day 8 | 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. |
| Sub-cohort: Absolute Values of Digital Physical Activity at Month 18 (Average of Months 18 to 19) | Up to 30 days from Month 18 (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. |
| Main Cohort: Absolute Values of Plasma Fibrinogen at Baseline | At Baseline (Day 1 of Month 1) | 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. |
| Main Cohort: Absolute Values of Plasma Fibrinogen at Month 30 | 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. |
| Main Cohort: Absolute Values of C-Reactive Protein at Baseline | At Baseline (Day 1 of Month 1) | 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. |
| Main Cohort: Absolute Values of C-Reactive Protein at Month 30 | At Month 30 | Blood samples were collected for the analysis of C-Reactive Protein. |
| Main Cohort: Absolute Values of Eosinophils and Neutrophils at Baseline | At Baseline (Day 1 of Month 1) | 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. |
| Main Cohort: Absolute Values of Eosinophils and Neutrophils at Month 30 | At Month 30 | Blood samples were collected for the analysis of eosinophils and neutrophils. |
| Main Cohort: Absolute Values of Hemoglobin at Baseline | At Baseline (Day 1 of Month 1) | 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. |
| Main Cohort: Absolute Values of Hemoglobin at Months 30 | At Month 30 | Blood samples were collected for the analysis of hemoglobin. |
| 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 | At Baseline (Day 1 of Month 1) | 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. |
| Sub-cohort: Absolute Values of Serum IP-10 and Serum sRAGE at Month 30 | At Month 30 | Blood samples were collected at Month 30 for the analysis of blood biomarkers serum IP-10 and serum sRAGE. |
| Sub-cohort: Absolute Values of Club Cell Protein (CC16) at Baseline | At Baseline (Day 1 of Month 1) | 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. |
| Sub-cohort: Absolute Values of CC16 at Month 30 | At Month 30 | Blood samples were collected for the analysis of blood biomarker CC16. |
| Sub-cohort: Absolute Values of Glycated Hemoglobin A1c (HbA1c) at Baseline | At Baseline (Day 1 of Month 1) | 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. |
| Sub-cohort: Absolute Values of HbA1c at Month 30 | At Month 30 | Blood samples were collected for the analysis of HbA1c. |
| Sub-cohort: Sputum Microbiome as Assessed by Molecular Methods | Up to 30 months | 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. |
| Sub-cohort: Absolute Values of Total Cell Count of Sputum Sample at Baseline | At Baseline (Day 1 of Month 1) | 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. |
| Sub-cohort: Absolute Values of Total Cell Count of Sputum Sample at Month 30 | At Month 30 | Sputum samples were collected from the participants for assessment of total cell count. |
| Main Cohort: Number of Participants With COPD Medication | Up to 30 months | 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). |
| Main Cohort: Number of Participants With Change From Baseline in Treatment Pattern | Baseline (Day 1 of Month 1) and Month 30 | 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. |
| Number of Participants With COPD Related Outpatient Visits | Up to 30 months | Number of participants with COPD related outpatient visits have been presented. |
| Number of Participants With Non-COPD Related Outpatient Visits | Up to 30 months | Number of participants with non-COPD related outpatient visits have been presented. |
| Number of Participants With COPD Related Emergency Visits | Up to 30 months | Number of participants with COPD related emergency visits have been presented. |
| Number of Participants With Non-COPD Related Emergency Visits | Up to 30 months | Number of participants with non-COPD related emergency visits have been presented. |
| Number of Participants With COPD Related Hospitalizations Visits | Up to 30 months | Number of participants with COPD related hospitalizations visits have been presented. |
| Number of Participants With Non-COPD Related Hospitalizations Visits | Up to 30 months | Number of participants with non-COPD related hospitalizations visits have been presented. |
| Direct Medical Costs Associated With COPD Medications During Study Period | Up to 30 months | 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. |
| Sub-cohort: Absolute Values of Airway Wall Area at Baseline | Baseline (Day 1 of Month 1) | 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. |
| Sub-cohort: Absolute Values of Airway Wall Area at Month 30 | 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. |
| Sub-cohort: Average of Airway Major Inner Diameter at Baseline | Baseline (Day 1 of Month 1) | 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. |
| Sub-cohort: Average of Airway Major Inner Diameter at Month 30 | 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. |
| Sub-cohort: Average of Airway Minor Inner Diameter at Baseline | Baseline (Day 1 of Month 1) | 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. |
| Sub-cohort: Average of Airway Minor Inner Diameter at Month 30 | 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. |
| Sub-cohort: Total Airway Count at Baseline | Baseline (Day 1 of Month 1) | 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. |
| Sub-cohort: Total Airway Count at Month 30 | 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. |
| Sub-cohort: Absolute Values of Perimeter of 10 Millimeter (mm) (Pi10) at Baseline | Baseline (Day 1 of Month 1) | 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. |
| Sub-cohort: Absolute Values of Pi10 at Month 30 | 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. |
| Sub-cohort: Computed Tomography (CT) Attenuation at the 15th Percentile of the Lung CT Histogram (Perc15) in Residual Volume at Baseline | Baseline (Day 1 of Month 1) | 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. |
| Sub-cohort: Perc15 in Residual Volume at Month 30 | 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. |
| Sub-cohort: Perc15 in Total Lung Capacity at Baseline | Baseline (Day 1 of Month 1) | 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. |
| Sub-cohort: Perc15 in Total Lung Capacity at Month 30 | 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. |
| Sub-cohort: Absolute Values of Low Attenuation Area -950 (LAA-950) at Baseline | Baseline (Day 1 of Month 1) | 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. |
| Sub-cohort: Absolute Values of LAA-950 at Month 30 | 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. |
| Sub-cohort: Absolute Values of Disease Probability Measure (DPM) to Assess Gas Trapping at Baseline | Baseline (Day 1 of Month 1) | 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. |
| Main Cohort: Rate of Moderate/Severe Exacerbations in COPD and Chronic Bronchitis Cohorts | Up to 30 months | 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. |
| Sub-cohort: Absolute Values of DPM to Assess Emphysema at Baseline | Baseline (Day 1 of Month 1) | 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. |
| Sub-cohort: Absolute Values of DPM to Assess Emphysema at Month 30 | 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. |
| Sub-cohort: Absolute Values of DPM to Assess Normal Tissue at Baseline | Baseline (Day 1 of Month 1) | 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. |
| Sub-cohort: Absolute Values of DPM to Assess Normal Tissue at Month 30 | 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. |
| Sub-cohort: Air Volume Ratio (RV/TLC) at Baseline | Baseline (Day 1 of Month 1) | 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. |
| Sub-cohort: Air Volume Ratio (RV/TLC) at Month 30 | 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. |
| Sub-cohort: Absolute Values of DPM to Assess Gas Trapping at Month 30 | 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. |
| Main Cohort: Change From Baseline in COPD Assessment Test (CAT) Score at Month 30 | Baseline (Day 1 of Month 1) and 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. |
Countries
China
Participant flow
Pre-assignment details
A total of 2005 participants were enrolled in this study, however only 2003 participants (1 participant withdrew consent and 1 participant withdrew due to investigator discretion) attended Visit 1 creating the Full Population.
Participants by arm
| Arm | Count |
|---|---|
| COPD Participants Participants with chronic obstructive pulmonary disease (COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study. | 1,696 |
| Participants With Chronic Bronchitis Participants with chronic bronchitis were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study. | 184 |
| Never Smoker Healthy Control Never smoker healthy participants were enrolled in this control cohort. No study treatment was administered during conduct of this non-interventional study. | 123 |
| Total | 2,003 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 50 | 0 | 0 |
| Overall Study | Not included in the Full Population due to Investigator discretion | 1 | 0 | 0 |
| Overall Study | Not included in the Full Population due to withdrew consent | 1 | 0 | 0 |
| Overall Study | Other | 102 | 11 | 5 |
| Overall Study | Physician Decision | 12 | 4 | 1 |
| Overall Study | Withdrawal by Subject | 81 | 4 | 1 |
Baseline characteristics
| Characteristic | COPD Participants | Participants With Chronic Bronchitis | Never Smoker Healthy Control | Total |
|---|---|---|---|---|
| Age, Continuous | 65.4 Years STANDARD_DEVIATION 7.46 | 61.3 Years STANDARD_DEVIATION 7.16 | 58.7 Years STANDARD_DEVIATION 6.72 | 64.6 Years STANDARD_DEVIATION 7.63 |
| Race/Ethnicity, Customized Asian - East Asian Heritage | 1696 Participants | 184 Participants | 123 Participants | 2003 Participants |
| Sex: Female, Male Female | 176 Participants | 24 Participants | 82 Participants | 282 Participants |
| Sex: Female, Male Male | 1520 Participants | 160 Participants | 41 Participants | 1721 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 41 / 1,696 | 2 / 184 | 0 / 123 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
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
Population: Full Population consisted of all participants who were enrolled in the study and attend Visit 1. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With COPD - GOLD Grade I | Main Cohort: Change From Baseline in Pre-bronchodilator and Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Month 30 | Pre-bronchodilator | -158.9 Milliliter | Standard Deviation 273.46 |
| Participants With COPD - GOLD Grade I | Main Cohort: Change From Baseline in Pre-bronchodilator and Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Month 30 | Post-bronchodilator | -168.1 Milliliter | Standard Deviation 252.93 |
| Participants With COPD - GOLD Grade II | Main Cohort: Change From Baseline in Pre-bronchodilator and Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Month 30 | Pre-bronchodilator | -93.9 Milliliter | Standard Deviation 271.65 |
| Participants With COPD - GOLD Grade II | Main Cohort: Change From Baseline in Pre-bronchodilator and Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Month 30 | Post-bronchodilator | -107.4 Milliliter | Standard Deviation 250.66 |
| Participants With COPD - GOLD Grade III | Main Cohort: Change From Baseline in Pre-bronchodilator and Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Month 30 | Pre-bronchodilator | -1.2 Milliliter | Standard Deviation 226.44 |
| Participants With COPD - GOLD Grade III | Main Cohort: Change From Baseline in Pre-bronchodilator and Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Month 30 | Post-bronchodilator | -34.7 Milliliter | Standard Deviation 207.13 |
| Participants With COPD - GOLD Grade IV | Main Cohort: Change From Baseline in Pre-bronchodilator and Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Month 30 | Pre-bronchodilator | -17.3 Milliliter | Standard Deviation 141.54 |
| Participants With COPD - GOLD Grade IV | Main Cohort: Change From Baseline in Pre-bronchodilator and Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Month 30 | Post-bronchodilator | -33.6 Milliliter | Standard Deviation 138.98 |
| Participants With Chronic Bronchitis | Main Cohort: Change From Baseline in Pre-bronchodilator and Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Month 30 | Pre-bronchodilator | -144.4 Milliliter | Standard Deviation 250.5 |
| Participants With Chronic Bronchitis | Main Cohort: Change From Baseline in Pre-bronchodilator and Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Month 30 | Post-bronchodilator | -148.2 Milliliter | Standard Deviation 229.19 |
| Never Smoker Healthy Control | Main Cohort: Change From Baseline in Pre-bronchodilator and Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Month 30 | Pre-bronchodilator | -53.6 Milliliter | Standard Deviation 222.51 |
| Never Smoker Healthy Control | Main Cohort: Change From Baseline in Pre-bronchodilator and Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Month 30 | Post-bronchodilator | -77.2 Milliliter | Standard Deviation 200.51 |
Primary
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
Population: Full Population consisted of all participants who were enrolled in the study and attend Visit 1. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With COPD - GOLD Grade I | Main Cohort: Change From Baseline in Pre-bronchodilator and Post-bronchodilator Forced Vital Capacity (FVC) at Month 30 | Post-bronchodilator | -241.7 Milliliter | Standard Deviation 345.52 |
| Participants With COPD - GOLD Grade I | Main Cohort: Change From Baseline in Pre-bronchodilator and Post-bronchodilator Forced Vital Capacity (FVC) at Month 30 | Pre-bronchodilator | -229.2 Milliliter | Standard Deviation 358.22 |
| Participants With COPD - GOLD Grade II | Main Cohort: Change From Baseline in Pre-bronchodilator and Post-bronchodilator Forced Vital Capacity (FVC) at Month 30 | Post-bronchodilator | -170.5 Milliliter | Standard Deviation 332.35 |
| Participants With COPD - GOLD Grade II | Main Cohort: Change From Baseline in Pre-bronchodilator and Post-bronchodilator Forced Vital Capacity (FVC) at Month 30 | Pre-bronchodilator | -161.0 Milliliter | Standard Deviation 351.83 |
| Participants With COPD - GOLD Grade III | Main Cohort: Change From Baseline in Pre-bronchodilator and Post-bronchodilator Forced Vital Capacity (FVC) at Month 30 | Post-bronchodilator | -115.8 Milliliter | Standard Deviation 344.63 |
| Participants With COPD - GOLD Grade III | Main Cohort: Change From Baseline in Pre-bronchodilator and Post-bronchodilator Forced Vital Capacity (FVC) at Month 30 | Pre-bronchodilator | -58.6 Milliliter | Standard Deviation 402.7 |
| Participants With COPD - GOLD Grade IV | Main Cohort: Change From Baseline in Pre-bronchodilator and Post-bronchodilator Forced Vital Capacity (FVC) at Month 30 | Pre-bronchodilator | -27.3 Milliliter | Standard Deviation 352.13 |
| Participants With COPD - GOLD Grade IV | Main Cohort: Change From Baseline in Pre-bronchodilator and Post-bronchodilator Forced Vital Capacity (FVC) at Month 30 | Post-bronchodilator | -101.6 Milliliter | Standard Deviation 302.39 |
| Participants With Chronic Bronchitis | Main Cohort: Change From Baseline in Pre-bronchodilator and Post-bronchodilator Forced Vital Capacity (FVC) at Month 30 | Pre-bronchodilator | -139.8 Milliliter | Standard Deviation 302.96 |
| Participants With Chronic Bronchitis | Main Cohort: Change From Baseline in Pre-bronchodilator and Post-bronchodilator Forced Vital Capacity (FVC) at Month 30 | Post-bronchodilator | -114.0 Milliliter | Standard Deviation 273.44 |
| Never Smoker Healthy Control | Main Cohort: Change From Baseline in Pre-bronchodilator and Post-bronchodilator Forced Vital Capacity (FVC) at Month 30 | Pre-bronchodilator | -26.4 Milliliter | Standard Deviation 264.49 |
| Never Smoker Healthy Control | Main Cohort: Change From Baseline in Pre-bronchodilator and Post-bronchodilator Forced Vital Capacity (FVC) at Month 30 | Post-bronchodilator | -81.9 Milliliter | Standard Deviation 227.64 |
Secondary
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
Population: HRU Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With COPD - GOLD Grade I | Direct Medical Costs Associated With COPD Medications During Study Period | Basic Insurance: Prescribing costs | 6330.98 Chinese Yuan | Standard Deviation 6999.658 |
| Participants With COPD - GOLD Grade I | Direct Medical Costs Associated With COPD Medications During Study Period | Out-of-pocket payment: Participant check | 1138.82 Chinese Yuan | Standard Deviation 2936.166 |
| Participants With COPD - GOLD Grade I | Direct Medical Costs Associated With COPD Medications During Study Period | Out-of-pocket payment: Hospital | 25416.68 Chinese Yuan | Standard Deviation 29042.578 |
| Participants With COPD - GOLD Grade I | Direct Medical Costs Associated With COPD Medications During Study Period | Basic Insurance: Participant therapy | 3052.55 Chinese Yuan | Standard Deviation 5819.362 |
| Participants With COPD - GOLD Grade I | Direct Medical Costs Associated With COPD Medications During Study Period | Basic Insurance: Participant check | 3447.89 Chinese Yuan | Standard Deviation 4982.828 |
| Participants With COPD - GOLD Grade I | Direct Medical Costs Associated With COPD Medications During Study Period | Basic Insurance: Outpatient | 5254.15 Chinese Yuan | Standard Deviation 5051.381 |
| Participants With COPD - GOLD Grade I | Direct Medical Costs Associated With COPD Medications During Study Period | Out-of-pocket payment: Participant therapy | 1177.49 Chinese Yuan | Standard Deviation 5938.384 |
| Participants With COPD - GOLD Grade I | Direct Medical Costs Associated With COPD Medications During Study Period | Out-of-pocket payment: Outpatient | 2088.99 Chinese Yuan | Standard Deviation 3896.868 |
| Participants With COPD - GOLD Grade I | Direct Medical Costs Associated With COPD Medications During Study Period | Out-of-pocket payment: Prescribing costs | 2468.19 Chinese Yuan | Standard Deviation 4715.511 |
| Participants With COPD - GOLD Grade I | Direct Medical Costs Associated With COPD Medications During Study Period | Out-of-pocket payment: Emergency | 962.12 Chinese Yuan | Standard Deviation 1354.719 |
| Participants With COPD - GOLD Grade I | Direct Medical Costs Associated With COPD Medications During Study Period | Basic Insurance: Hospital | 20069.34 Chinese Yuan | Standard Deviation 20912.555 |
| Participants With COPD - GOLD Grade I | Direct Medical Costs Associated With COPD Medications During Study Period | Basic Insurance: Emergency | 1016.38 Chinese Yuan | Standard Deviation 1054.997 |
| Participants With COPD - GOLD Grade II | Direct Medical Costs Associated With COPD Medications During Study Period | Out-of-pocket payment: Participant check | 543.96 Chinese Yuan | Standard Deviation 368.125 |
| Participants With COPD - GOLD Grade II | Direct Medical Costs Associated With COPD Medications During Study Period | Basic Insurance: Hospital | 9637.41 Chinese Yuan | Standard Deviation 3660.536 |
| Participants With COPD - GOLD Grade II | Direct Medical Costs Associated With COPD Medications During Study Period | Out-of-pocket payment: Outpatient | 1105.52 Chinese Yuan | Standard Deviation 1447.27 |
| Participants With COPD - GOLD Grade II | Direct Medical Costs Associated With COPD Medications During Study Period | Basic Insurance: Outpatient | 1773.34 Chinese Yuan | Standard Deviation 2593.387 |
| Participants With COPD - GOLD Grade II | Direct Medical Costs Associated With COPD Medications During Study Period | Out-of-pocket payment: Emergency | 430.46 Chinese Yuan | Standard Deviation 190.164 |
| Participants With COPD - GOLD Grade II | Direct Medical Costs Associated With COPD Medications During Study Period | Basic Insurance: Emergency | 102.58 Chinese Yuan | Standard Deviation 119.607 |
| Participants With COPD - GOLD Grade II | Direct Medical Costs Associated With COPD Medications During Study Period | Basic Insurance: Participant check | 2191.53 Chinese Yuan | Standard Deviation 2314.739 |
| Participants With COPD - GOLD Grade II | Direct Medical Costs Associated With COPD Medications During Study Period | Out-of-pocket payment: Participant therapy | 68.26 Chinese Yuan | Standard Deviation 155.206 |
| Participants With COPD - GOLD Grade II | Direct Medical Costs Associated With COPD Medications During Study Period | Basic Insurance: Participant therapy | 1014.96 Chinese Yuan | Standard Deviation 1381.025 |
| Participants With COPD - GOLD Grade II | Direct Medical Costs Associated With COPD Medications During Study Period | Out-of-pocket payment: Prescribing costs | 1458.08 Chinese Yuan | Standard Deviation 1744.227 |
| Participants With COPD - GOLD Grade II | Direct Medical Costs Associated With COPD Medications During Study Period | Basic Insurance: Prescribing costs | 1747.48 Chinese Yuan | Standard Deviation 2348.413 |
| Participants With COPD - GOLD Grade III | Direct Medical Costs Associated With COPD Medications During Study Period | Basic Insurance: Participant therapy | 17.00 Chinese Yuan | — |
| Participants With COPD - GOLD Grade III | Direct Medical Costs Associated With COPD Medications During Study Period | Basic Insurance: Outpatient | 268.00 Chinese Yuan | Standard Deviation 294.156 |
| Participants With COPD - GOLD Grade III | Direct Medical Costs Associated With COPD Medications During Study Period | Basic Insurance: Participant check | 60.00 Chinese Yuan | — |
| Participants With COPD - GOLD Grade III | Direct Medical Costs Associated With COPD Medications During Study Period | Basic Insurance: Prescribing costs | 459.00 Chinese Yuan | — |
| Participants With COPD - GOLD Grade III | Direct Medical Costs Associated With COPD Medications During Study Period | Out-of-pocket payment: Participant check | 58.00 Chinese Yuan | — |
| Participants With COPD - GOLD Grade III | Direct Medical Costs Associated With COPD Medications During Study Period | Out-of-pocket payment: Outpatient | 58.00 Chinese Yuan | — |
Secondary
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
Population: Full Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With COPD - GOLD Grade I | Main Cohort: Absolute Values of CAT Score at Month 30 | 7.5 Scores on a scale | Standard Deviation 5.33 |
| Participants With COPD - GOLD Grade II | Main Cohort: Absolute Values of CAT Score at Month 30 | 5.7 Scores on a scale | Standard Deviation 4.18 |
| Participants With COPD - GOLD Grade III | Main Cohort: Absolute Values of CAT Score at Month 30 | 1.3 Scores on a scale | Standard Deviation 2.36 |
Secondary
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)
Population: Full Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With COPD - GOLD Grade I | Main Cohort: Absolute Values of C-Reactive Protein at Baseline | 0.2791 Milligram per deciliter | Standard Deviation 0.6853 |
| Participants With COPD - GOLD Grade II | Main Cohort: Absolute Values of C-Reactive Protein at Baseline | 0.2463 Milligram per deciliter | Standard Deviation 0.93353 |
| Participants With COPD - GOLD Grade III | Main Cohort: Absolute Values of C-Reactive Protein at Baseline | 0.1654 Milligram per deciliter | Standard Deviation 0.40848 |
Secondary
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
Population: Full Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With COPD - GOLD Grade I | Main Cohort: Absolute Values of C-Reactive Protein at Month 30 | 0.3411 Milligram per deciliter | Standard Deviation 0.71558 |
| Participants With COPD - GOLD Grade II | Main Cohort: Absolute Values of C-Reactive Protein at Month 30 | 0.2734 Milligram per deciliter | Standard Deviation 0.6366 |
| Participants With COPD - GOLD Grade III | Main Cohort: Absolute Values of C-Reactive Protein at Month 30 | 0.1645 Milligram per deciliter | Standard Deviation 0.20928 |
Secondary
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)
Population: Full Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With COPD - GOLD Grade I | Main Cohort: Absolute Values of Eosinophils and Neutrophils at Baseline | Eosinophils | 0.231 Giga cells per liter | Standard Deviation 0.2084 |
| Participants With COPD - GOLD Grade I | Main Cohort: Absolute Values of Eosinophils and Neutrophils at Baseline | Neutrophils | 4.467 Giga cells per liter | Standard Deviation 1.6253 |
| Participants With COPD - GOLD Grade II | Main Cohort: Absolute Values of Eosinophils and Neutrophils at Baseline | Eosinophils | 0.199 Giga cells per liter | Standard Deviation 0.1711 |
| Participants With COPD - GOLD Grade II | Main Cohort: Absolute Values of Eosinophils and Neutrophils at Baseline | Neutrophils | 4.180 Giga cells per liter | Standard Deviation 1.5366 |
| Participants With COPD - GOLD Grade III | Main Cohort: Absolute Values of Eosinophils and Neutrophils at Baseline | Eosinophils | 0.109 Giga cells per liter | Standard Deviation 0.1006 |
| Participants With COPD - GOLD Grade III | Main Cohort: Absolute Values of Eosinophils and Neutrophils at Baseline | Neutrophils | 3.810 Giga cells per liter | Standard Deviation 0.9967 |
Secondary
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
Population: Full Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With COPD - GOLD Grade I | Main Cohort: Absolute Values of Eosinophils and Neutrophils at Month 30 | Eosinophils | 0.267 Giga cells per liter | Standard Deviation 0.2921 |
| Participants With COPD - GOLD Grade I | Main Cohort: Absolute Values of Eosinophils and Neutrophils at Month 30 | Neutrophils | 4.516 Giga cells per liter | Standard Deviation 1.6207 |
| Participants With COPD - GOLD Grade II | Main Cohort: Absolute Values of Eosinophils and Neutrophils at Month 30 | Eosinophils | 0.228 Giga cells per liter | Standard Deviation 0.2351 |
| Participants With COPD - GOLD Grade II | Main Cohort: Absolute Values of Eosinophils and Neutrophils at Month 30 | Neutrophils | 4.198 Giga cells per liter | Standard Deviation 1.6725 |
| Participants With COPD - GOLD Grade III | Main Cohort: Absolute Values of Eosinophils and Neutrophils at Month 30 | Eosinophils | 0.145 Giga cells per liter | Standard Deviation 0.1853 |
| Participants With COPD - GOLD Grade III | Main Cohort: Absolute Values of Eosinophils and Neutrophils at Month 30 | Neutrophils | 3.667 Giga cells per liter | Standard Deviation 1.0537 |
Secondary
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)
Population: Full Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With COPD - GOLD Grade I | Main Cohort: Absolute Values of Hemoglobin at Baseline | 142.2 Grams per liter | Standard Deviation 13.03 |
| Participants With COPD - GOLD Grade II | Main Cohort: Absolute Values of Hemoglobin at Baseline | 141.6 Grams per liter | Standard Deviation 11.9 |
| Participants With COPD - GOLD Grade III | Main Cohort: Absolute Values of Hemoglobin at Baseline | 132.7 Grams per liter | Standard Deviation 15.03 |
Secondary
Main Cohort: Absolute Values of Hemoglobin at Months 30
Blood samples were collected for the analysis of hemoglobin.
Time frame: At Month 30
Population: Full Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With COPD - GOLD Grade I | Main Cohort: Absolute Values of Hemoglobin at Months 30 | 143.4 Grams per liter | Standard Deviation 13.5 |
| Participants With COPD - GOLD Grade II | Main Cohort: Absolute Values of Hemoglobin at Months 30 | 144.3 Grams per liter | Standard Deviation 12.29 |
| Participants With COPD - GOLD Grade III | Main Cohort: Absolute Values of Hemoglobin at Months 30 | 135.3 Grams per liter | Standard Deviation 12.97 |
Secondary
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)
Population: Full Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With COPD - GOLD Grade I | Main Cohort: Absolute Values of Plasma Fibrinogen at Baseline | 337.1 Milligram per deciliter | Standard Deviation 82.59 |
| Participants With COPD - GOLD Grade II | Main Cohort: Absolute Values of Plasma Fibrinogen at Baseline | 315.8 Milligram per deciliter | Standard Deviation 89.97 |
| Participants With COPD - GOLD Grade III | Main Cohort: Absolute Values of Plasma Fibrinogen at Baseline | 304.4 Milligram per deciliter | Standard Deviation 73.36 |
Secondary
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
Population: Full Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With COPD - GOLD Grade I | Main Cohort: Absolute Values of Plasma Fibrinogen at Month 30 | 341.2 Milligram per deciliter | Standard Deviation 82.94 |
| Participants With COPD - GOLD Grade II | Main Cohort: Absolute Values of Plasma Fibrinogen at Month 30 | 328.4 Milligram per deciliter | Standard Deviation 66.1 |
| Participants With COPD - GOLD Grade III | Main Cohort: Absolute Values of Plasma Fibrinogen at Month 30 | 315.9 Milligram per deciliter | Standard Deviation 63.01 |
Secondary
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
Population: Full Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With COPD - GOLD Grade I | Main Cohort: Change From Baseline in COPD Assessment Test (CAT) Score at Month 30 | -0.9 Scores on a scale | Standard Deviation 5.84 |
| Participants With COPD - GOLD Grade II | Main Cohort: Change From Baseline in COPD Assessment Test (CAT) Score at Month 30 | -2.3 Scores on a scale | Standard Deviation 5.45 |
| Participants With COPD - GOLD Grade III | Main Cohort: Change From Baseline in COPD Assessment Test (CAT) Score at Month 30 | 0.3 Scores on a scale | Standard Deviation 2.46 |
Secondary
Main Cohort: Number of Participants Who Died
Number of participants who died during study have been presented.
Time frame: Up to 30 months
Population: Full Population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants With COPD - GOLD Grade I | Main Cohort: Number of Participants Who Died | 41 Participants |
| Participants With COPD - GOLD Grade II | Main Cohort: Number of Participants Who Died | 2 Participants |
| Participants With COPD - GOLD Grade III | Main Cohort: Number of Participants Who Died | 0 Participants |
Secondary
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
Population: Full Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With COPD - GOLD Grade I | Main Cohort: Number of Participants With Any CID Event and Its Components From Months 18 to 30 | Any CID | 1086 Participants |
| Participants With COPD - GOLD Grade I | Main Cohort: Number of Participants With Any CID Event and Its Components From Months 18 to 30 | Exacerbation CID | 177 Participants |
| Participants With COPD - GOLD Grade I | Main Cohort: Number of Participants With Any CID Event and Its Components From Months 18 to 30 | FEV1 CID | 594 Participants |
| Participants With COPD - GOLD Grade I | Main Cohort: Number of Participants With Any CID Event and Its Components From Months 18 to 30 | CAT CID | 771 Participants |
| Participants With COPD - GOLD Grade II | Main Cohort: Number of Participants With Any CID Event and Its Components From Months 18 to 30 | CAT CID | 54 Participants |
| Participants With COPD - GOLD Grade II | Main Cohort: Number of Participants With Any CID Event and Its Components From Months 18 to 30 | Any CID | 93 Participants |
| Participants With COPD - GOLD Grade II | Main Cohort: Number of Participants With Any CID Event and Its Components From Months 18 to 30 | FEV1 CID | 61 Participants |
| Participants With COPD - GOLD Grade II | Main Cohort: Number of Participants With Any CID Event and Its Components From Months 18 to 30 | Exacerbation CID | 2 Participants |
| Participants With COPD - GOLD Grade III | Main Cohort: Number of Participants With Any CID Event and Its Components From Months 18 to 30 | CAT CID | 48 Participants |
| Participants With COPD - GOLD Grade III | Main Cohort: Number of Participants With Any CID Event and Its Components From Months 18 to 30 | Exacerbation CID | 0 Participants |
| Participants With COPD - GOLD Grade III | Main Cohort: Number of Participants With Any CID Event and Its Components From Months 18 to 30 | FEV1 CID | 37 Participants |
| Participants With COPD - GOLD Grade III | Main Cohort: Number of Participants With Any CID Event and Its Components From Months 18 to 30 | Any CID | 68 Participants |
Secondary
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
Population: Full Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With COPD - GOLD Grade I | Main Cohort: Number of Participants With Any CID Event and Its Components From Months 6 to 18 | Exacerbation CID | 211 Participants |
| Participants With COPD - GOLD Grade I | Main Cohort: Number of Participants With Any CID Event and Its Components From Months 6 to 18 | Any CID | 1120 Participants |
| Participants With COPD - GOLD Grade I | Main Cohort: Number of Participants With Any CID Event and Its Components From Months 6 to 18 | FEV1 CID | 524 Participants |
| Participants With COPD - GOLD Grade I | Main Cohort: Number of Participants With Any CID Event and Its Components From Months 6 to 18 | CAT CID | 794 Participants |
| Participants With COPD - GOLD Grade II | Main Cohort: Number of Participants With Any CID Event and Its Components From Months 6 to 18 | CAT CID | 52 Participants |
| Participants With COPD - GOLD Grade II | Main Cohort: Number of Participants With Any CID Event and Its Components From Months 6 to 18 | FEV1 CID | 64 Participants |
| Participants With COPD - GOLD Grade II | Main Cohort: Number of Participants With Any CID Event and Its Components From Months 6 to 18 | Any CID | 97 Participants |
| Participants With COPD - GOLD Grade II | Main Cohort: Number of Participants With Any CID Event and Its Components From Months 6 to 18 | Exacerbation CID | 0 Participants |
| Participants With COPD - GOLD Grade III | Main Cohort: Number of Participants With Any CID Event and Its Components From Months 6 to 18 | Any CID | 82 Participants |
| Participants With COPD - GOLD Grade III | Main Cohort: Number of Participants With Any CID Event and Its Components From Months 6 to 18 | Exacerbation CID | 0 Participants |
| Participants With COPD - GOLD Grade III | Main Cohort: Number of Participants With Any CID Event and Its Components From Months 6 to 18 | FEV1 CID | 42 Participants |
| Participants With COPD - GOLD Grade III | Main Cohort: Number of Participants With Any CID Event and Its Components From Months 6 to 18 | CAT CID | 60 Participants |
Secondary
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
Population: Full Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With COPD - GOLD Grade I | Main Cohort: Number of Participants With Any Clinically Important Deterioration (CID) Event and Its Components From Baseline to Month 6 | Any CID | 897 Participants |
| Participants With COPD - GOLD Grade I | Main Cohort: Number of Participants With Any Clinically Important Deterioration (CID) Event and Its Components From Baseline to Month 6 | CAT CID | 567 Participants |
| Participants With COPD - GOLD Grade I | Main Cohort: Number of Participants With Any Clinically Important Deterioration (CID) Event and Its Components From Baseline to Month 6 | FEV1 CID | 431 Participants |
| Participants With COPD - GOLD Grade I | Main Cohort: Number of Participants With Any Clinically Important Deterioration (CID) Event and Its Components From Baseline to Month 6 | Exacerbation CID | 153 Participants |
| Participants With COPD - GOLD Grade II | Main Cohort: Number of Participants With Any Clinically Important Deterioration (CID) Event and Its Components From Baseline to Month 6 | FEV1 CID | 55 Participants |
| Participants With COPD - GOLD Grade II | Main Cohort: Number of Participants With Any Clinically Important Deterioration (CID) Event and Its Components From Baseline to Month 6 | Exacerbation CID | 1 Participants |
| Participants With COPD - GOLD Grade II | Main Cohort: Number of Participants With Any Clinically Important Deterioration (CID) Event and Its Components From Baseline to Month 6 | CAT CID | 53 Participants |
| Participants With COPD - GOLD Grade II | Main Cohort: Number of Participants With Any Clinically Important Deterioration (CID) Event and Its Components From Baseline to Month 6 | Any CID | 90 Participants |
| Participants With COPD - GOLD Grade III | Main Cohort: Number of Participants With Any Clinically Important Deterioration (CID) Event and Its Components From Baseline to Month 6 | CAT CID | 31 Participants |
| Participants With COPD - GOLD Grade III | Main Cohort: Number of Participants With Any Clinically Important Deterioration (CID) Event and Its Components From Baseline to Month 6 | Any CID | 58 Participants |
| Participants With COPD - GOLD Grade III | Main Cohort: Number of Participants With Any Clinically Important Deterioration (CID) Event and Its Components From Baseline to Month 6 | Exacerbation CID | 0 Participants |
| Participants With COPD - GOLD Grade III | Main Cohort: Number of Participants With Any Clinically Important Deterioration (CID) Event and Its Components From Baseline to Month 6 | FEV1 CID | 36 Participants |
Secondary
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
Population: Full Population. Data was presented for all participants in a single arm and not separated by their health status (COPD, chronic bronchitis and never smoker) as defined in the SAP as this was non-interventional study and it was not an intent to compare data for treatment patterns across participants' health status.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With COPD - GOLD Grade I | Main Cohort: Number of Participants With Change From Baseline in Treatment Pattern | Step-up | 104 Participants |
| Participants With COPD - GOLD Grade I | Main Cohort: Number of Participants With Change From Baseline in Treatment Pattern | Switch | 0 Participants |
| Participants With COPD - GOLD Grade I | Main Cohort: Number of Participants With Change From Baseline in Treatment Pattern | Stable | 32 Participants |
| Participants With COPD - GOLD Grade I | Main Cohort: Number of Participants With Change From Baseline in Treatment Pattern | Step-down | 10 Participants |
| Participants With COPD - GOLD Grade I | Main Cohort: Number of Participants With Change From Baseline in Treatment Pattern | Stop/Missing | 309 Participants |
| Participants With COPD - GOLD Grade I | Main Cohort: Number of Participants With Change From Baseline in Treatment Pattern | Naive | 1548 Participants |
Secondary
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
Population: Full Population. Data was presented for all participants in a single arm and not separated by their health status (COPD, chronic bronchitis and never smoker) as defined in the SAP as this was non-interventional study and it was not an intent to compare data for COPD medication across participants' health status.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With COPD - GOLD Grade I | Main Cohort: Number of Participants With COPD Medication | Naive | 1649 Participants |
| Participants With COPD - GOLD Grade I | Main Cohort: Number of Participants With COPD Medication | LAMA | 102 Participants |
| Participants With COPD - GOLD Grade I | Main Cohort: Number of Participants With COPD Medication | LABA | 8 Participants |
| Participants With COPD - GOLD Grade I | Main Cohort: Number of Participants With COPD Medication | ICS/LABA | 115 Participants |
| Participants With COPD - GOLD Grade I | Main Cohort: Number of Participants With COPD Medication | LAMA/LABA | 77 Participants |
| Participants With COPD - GOLD Grade I | Main Cohort: Number of Participants With COPD Medication | Triple (open) | 19 Participants |
| Participants With COPD - GOLD Grade I | Main Cohort: Number of Participants With COPD Medication | Triple (closed) | 33 Participants |
Secondary
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
Population: Full Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants With COPD - GOLD Grade I | Main Cohort: Rate of Moderate/Severe Exacerbations in COPD and Chronic Bronchitis Cohorts | 0.08 Exacerbations per participant per year |
| Participants With COPD - GOLD Grade II | Main Cohort: Rate of Moderate/Severe Exacerbations in COPD and Chronic Bronchitis Cohorts | 0.12 Exacerbations per participant per year |
| Participants With COPD - GOLD Grade III | Main Cohort: Rate of Moderate/Severe Exacerbations in COPD and Chronic Bronchitis Cohorts | 0.26 Exacerbations per participant per year |
| Participants With COPD - GOLD Grade IV | Main Cohort: Rate of Moderate/Severe Exacerbations in COPD and Chronic Bronchitis Cohorts | 0.35 Exacerbations per participant per year |
| Participants With Chronic Bronchitis | Main Cohort: Rate of Moderate/Severe Exacerbations in COPD and Chronic Bronchitis Cohorts | 0.02 Exacerbations per participant per year |
Secondary
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
Population: Full Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With COPD - GOLD Grade I | Main Cohort: Total Score of CAPTURE at Month 18 | 2.5 Scores on a scale | Standard Deviation 1.48 |
| Participants With COPD - GOLD Grade II | Main Cohort: Total Score of CAPTURE at Month 18 | 1.8 Scores on a scale | Standard Deviation 1.49 |
| Participants With COPD - GOLD Grade III | Main Cohort: Total Score of CAPTURE at Month 18 | 0.4 Scores on a scale | Standard Deviation 0.69 |
Secondary
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)
Population: Full Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With COPD - GOLD Grade I | Main Cohort: Total Score of COPD Assessment in Primary Care to Identify Undiagnosed Respiratory Disease and Exacerbation Risk (CAPTURE) at Baseline | 2.6 Scores on a scale | Standard Deviation 1.48 |
| Participants With COPD - GOLD Grade II | Main Cohort: Total Score of COPD Assessment in Primary Care to Identify Undiagnosed Respiratory Disease and Exacerbation Risk (CAPTURE) at Baseline | 2.0 Scores on a scale | Standard Deviation 1.37 |
| Participants With COPD - GOLD Grade III | Main Cohort: Total Score of COPD Assessment in Primary Care to Identify Undiagnosed Respiratory Disease and Exacerbation Risk (CAPTURE) at Baseline | 0.3 Scores on a scale | Standard Deviation 0.55 |
Secondary
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
Population: HRU Population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants With COPD - GOLD Grade I | Number of Participants With COPD Related Emergency Visits | 185 Participants |
| Participants With COPD - GOLD Grade II | Number of Participants With COPD Related Emergency Visits | 5 Participants |
| Participants With COPD - GOLD Grade III | Number of Participants With COPD Related Emergency Visits | 0 Participants |
Secondary
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
Population: HRU Population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants With COPD - GOLD Grade I | Number of Participants With COPD Related Hospitalizations Visits | 276 Participants |
| Participants With COPD - GOLD Grade II | Number of Participants With COPD Related Hospitalizations Visits | 6 Participants |
| Participants With COPD - GOLD Grade III | Number of Participants With COPD Related Hospitalizations Visits | 0 Participants |
Secondary
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
Population: Health Resource Utilization (HRU) is a subset of Full population which consists of participants who used healthcare resources. Due to feasibility issues in capturing data from certain sites via Hospital Information System (HIS), participants enrolled at those sites were not included in the HRU analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants With COPD - GOLD Grade I | Number of Participants With COPD Related Outpatient Visits | 1240 Participants |
| Participants With COPD - GOLD Grade II | Number of Participants With COPD Related Outpatient Visits | 50 Participants |
| Participants With COPD - GOLD Grade III | Number of Participants With COPD Related Outpatient Visits | 3 Participants |
Secondary
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
Population: HRU Population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants With COPD - GOLD Grade I | Number of Participants With Non-COPD Related Emergency Visits | 291 Participants |
| Participants With COPD - GOLD Grade II | Number of Participants With Non-COPD Related Emergency Visits | 32 Participants |
| Participants With COPD - GOLD Grade III | Number of Participants With Non-COPD Related Emergency Visits | 24 Participants |
Secondary
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
Population: HRU Population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants With COPD - GOLD Grade I | Number of Participants With Non-COPD Related Hospitalizations Visits | 0 Participants |
| Participants With COPD - GOLD Grade II | Number of Participants With Non-COPD Related Hospitalizations Visits | 0 Participants |
| Participants With COPD - GOLD Grade III | Number of Participants With Non-COPD Related Hospitalizations Visits | 0 Participants |
Secondary
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
Population: HRU Population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants With COPD - GOLD Grade I | Number of Participants With Non-COPD Related Outpatient Visits | 0 Participants |
| Participants With COPD - GOLD Grade II | Number of Participants With Non-COPD Related Outpatient Visits | 0 Participants |
| Participants With COPD - GOLD Grade III | Number of Participants With Non-COPD Related Outpatient Visits | 0 Participants |
Secondary
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)
Population: Sub-cohort Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With COPD - GOLD Grade I | Sub-cohort: Absolute Values of Airway Wall Area at Baseline | 0.630 Ratio | Standard Deviation 0.0408 |
| Participants With COPD - GOLD Grade II | Sub-cohort: Absolute Values of Airway Wall Area at Baseline | 0.623 Ratio | Standard Deviation 0.0335 |
| Participants With COPD - GOLD Grade III | Sub-cohort: Absolute Values of Airway Wall Area at Baseline | 0.631 Ratio | Standard Deviation 0.0321 |
Secondary
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
Population: Sub-cohort Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With COPD - GOLD Grade I | Sub-cohort: Absolute Values of Airway Wall Area at Month 30 | 0.628 Ratio | Standard Deviation 0.0533 |
| Participants With COPD - GOLD Grade II | Sub-cohort: Absolute Values of Airway Wall Area at Month 30 | 0.627 Ratio | Standard Deviation 0.0384 |
| Participants With COPD - GOLD Grade III | Sub-cohort: Absolute Values of Airway Wall Area at Month 30 | 0.639 Ratio | Standard Deviation 0.0364 |
Secondary
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
Population: Sub-cohort Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With COPD - GOLD Grade I | Sub-cohort: Absolute Values of CC16 at Month 30 | 15.2812 Nanogram per milliliter | Standard Deviation 10.90814 |
| Participants With COPD - GOLD Grade II | Sub-cohort: Absolute Values of CC16 at Month 30 | 15.5412 Nanogram per milliliter | Standard Deviation 10.78253 |
| Participants With COPD - GOLD Grade III | Sub-cohort: Absolute Values of CC16 at Month 30 | 14.4739 Nanogram per milliliter | Standard Deviation 8.45046 |
Secondary
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)
Population: Sub-cohort Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With COPD - GOLD Grade I | Sub-cohort: Absolute Values of Club Cell Protein (CC16) at Baseline | 8.8512 Nanogram per milliliter | Standard Deviation 6.80359 |
| Participants With COPD - GOLD Grade II | Sub-cohort: Absolute Values of Club Cell Protein (CC16) at Baseline | 9.2704 Nanogram per milliliter | Standard Deviation 7.29006 |
| Participants With COPD - GOLD Grade III | Sub-cohort: Absolute Values of Club Cell Protein (CC16) at Baseline | 7.8313 Nanogram per milliliter | Standard Deviation 5.76284 |
Secondary
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)
Population: Sub-cohort Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With COPD - GOLD Grade I | Sub-cohort: Absolute Values of Digital Physical Activity at Baseline (Average of Days 1 to 7) | 7986.2 Steps per day | Standard Deviation 3433.46 |
| Participants With COPD - GOLD Grade II | Sub-cohort: Absolute Values of Digital Physical Activity at Baseline (Average of Days 1 to 7) | 8743.2 Steps per day | Standard Deviation 3750.53 |
| Participants With COPD - GOLD Grade III | Sub-cohort: Absolute Values of Digital Physical Activity at Baseline (Average of Days 1 to 7) | 12063.6 Steps per day | Standard Deviation 4152.42 |
Secondary
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)
Population: Sub-cohort Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With COPD - GOLD Grade I | Sub-cohort: Absolute Values of Digital Physical Activity at Month 18 (Average of Months 18 to 19) | 6138.3 Steps per day | Standard Deviation 3664.12 |
| Participants With COPD - GOLD Grade II | Sub-cohort: Absolute Values of Digital Physical Activity at Month 18 (Average of Months 18 to 19) | 6454.3 Steps per day | Standard Deviation 3207.73 |
| Participants With COPD - GOLD Grade III | Sub-cohort: Absolute Values of Digital Physical Activity at Month 18 (Average of Months 18 to 19) | 7495.4 Steps per day | Standard Deviation 4723.39 |
Secondary
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
Population: Sub-cohort Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With COPD - GOLD Grade I | Sub-cohort: Absolute Values of Digital Physical Activity at Month 1 (Average of Day 8 to Month 1) | 8461.3 Steps per day | Standard Deviation 3750.31 |
| Participants With COPD - GOLD Grade II | Sub-cohort: Absolute Values of Digital Physical Activity at Month 1 (Average of Day 8 to Month 1) | 9284.5 Steps per day | Standard Deviation 4011.25 |
| Participants With COPD - GOLD Grade III | Sub-cohort: Absolute Values of Digital Physical Activity at Month 1 (Average of Day 8 to Month 1) | 12790.5 Steps per day | Standard Deviation 4233.32 |
Secondary
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)
Population: Sub-cohort Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With COPD - GOLD Grade I | Sub-cohort: Absolute Values of Disease Probability Measure (DPM) to Assess Gas Trapping at Baseline | 44.898 % of whole lung associated with GT | Standard Deviation 17.5307 |
| Participants With COPD - GOLD Grade II | Sub-cohort: Absolute Values of Disease Probability Measure (DPM) to Assess Gas Trapping at Baseline | 28.978 % of whole lung associated with GT | Standard Deviation 20.2675 |
| Participants With COPD - GOLD Grade III | Sub-cohort: Absolute Values of Disease Probability Measure (DPM) to Assess Gas Trapping at Baseline | 24.832 % of whole lung associated with GT | Standard Deviation 18.2977 |
Secondary
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)
Population: Sub-cohort Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With COPD - GOLD Grade I | Sub-cohort: Absolute Values of DPM to Assess Emphysema at Baseline | 13.068 %of whole lung associated with emphysema | Standard Deviation 12.228 |
| Participants With COPD - GOLD Grade II | Sub-cohort: Absolute Values of DPM to Assess Emphysema at Baseline | 2.402 %of whole lung associated with emphysema | Standard Deviation 5.3194 |
| Participants With COPD - GOLD Grade III | Sub-cohort: Absolute Values of DPM to Assess Emphysema at Baseline | 0.254 %of whole lung associated with emphysema | Standard Deviation 0.5837 |
Secondary
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
Population: Sub-cohort Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With COPD - GOLD Grade I | Sub-cohort: Absolute Values of DPM to Assess Emphysema at Month 30 | 15.093 %of whole lung associated with emphysema | Standard Deviation 12.4986 |
| Participants With COPD - GOLD Grade II | Sub-cohort: Absolute Values of DPM to Assess Emphysema at Month 30 | 2.518 %of whole lung associated with emphysema | Standard Deviation 3.673 |
| Participants With COPD - GOLD Grade III | Sub-cohort: Absolute Values of DPM to Assess Emphysema at Month 30 | 0.877 %of whole lung associated with emphysema | Standard Deviation 1.9884 |
Secondary
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
Population: Sub-cohort Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With COPD - GOLD Grade I | Sub-cohort: Absolute Values of DPM to Assess Gas Trapping at Month 30 | 43.210 % of whole lung associated with GT | Standard Deviation 14.2281 |
| Participants With COPD - GOLD Grade II | Sub-cohort: Absolute Values of DPM to Assess Gas Trapping at Month 30 | 29.414 % of whole lung associated with GT | Standard Deviation 16.1524 |
| Participants With COPD - GOLD Grade III | Sub-cohort: Absolute Values of DPM to Assess Gas Trapping at Month 30 | 32.157 % of whole lung associated with GT | Standard Deviation 20.138 |
Secondary
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)
Population: Sub-cohort Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With COPD - GOLD Grade I | Sub-cohort: Absolute Values of DPM to Assess Normal Tissue at Baseline | 42.035 % of whole lung associated with NT | Standard Deviation 20.8647 |
| Participants With COPD - GOLD Grade II | Sub-cohort: Absolute Values of DPM to Assess Normal Tissue at Baseline | 68.620 % of whole lung associated with NT | Standard Deviation 21.7128 |
| Participants With COPD - GOLD Grade III | Sub-cohort: Absolute Values of DPM to Assess Normal Tissue at Baseline | 74.914 % of whole lung associated with NT | Standard Deviation 18.3597 |
Secondary
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
Population: Sub-cohort Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With COPD - GOLD Grade I | Sub-cohort: Absolute Values of DPM to Assess Normal Tissue at Month 30 | 41.697 % of whole lung associated with NT | Standard Deviation 19.2811 |
| Participants With COPD - GOLD Grade II | Sub-cohort: Absolute Values of DPM to Assess Normal Tissue at Month 30 | 68.068 % of whole lung associated with NT | Standard Deviation 17.7974 |
| Participants With COPD - GOLD Grade III | Sub-cohort: Absolute Values of DPM to Assess Normal Tissue at Month 30 | 66.966 % of whole lung associated with NT | Standard Deviation 21.3521 |
Secondary
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)
Population: Sub-cohort Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With COPD - GOLD Grade I | Sub-cohort: Absolute Values of Glycated Hemoglobin A1c (HbA1c) at Baseline | 5.68 Percentage of HbA1c in blood | Standard Deviation 0.66 |
| Participants With COPD - GOLD Grade II | Sub-cohort: Absolute Values of Glycated Hemoglobin A1c (HbA1c) at Baseline | 5.87 Percentage of HbA1c in blood | Standard Deviation 0.989 |
| Participants With COPD - GOLD Grade III | Sub-cohort: Absolute Values of Glycated Hemoglobin A1c (HbA1c) at Baseline | 5.66 Percentage of HbA1c in blood | Standard Deviation 0.901 |
Secondary
Sub-cohort: Absolute Values of HbA1c at Month 30
Blood samples were collected for the analysis of HbA1c.
Time frame: At Month 30
Population: Sub-cohort Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With COPD - GOLD Grade I | Sub-cohort: Absolute Values of HbA1c at Month 30 | 5.74 Percentage of HbA1c in blood | Standard Deviation 0.754 |
| Participants With COPD - GOLD Grade II | Sub-cohort: Absolute Values of HbA1c at Month 30 | 5.99 Percentage of HbA1c in blood | Standard Deviation 1.227 |
| Participants With COPD - GOLD Grade III | Sub-cohort: Absolute Values of HbA1c at Month 30 | 5.83 Percentage of HbA1c in blood | Standard Deviation 0.739 |
Secondary
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
Population: Sub-cohort Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With COPD - GOLD Grade I | Sub-cohort: Absolute Values of LAA-950 at Month 30 | 9.765 % of voxels with attenuation <=-950 HU | Standard Deviation 9.058 |
| Participants With COPD - GOLD Grade II | Sub-cohort: Absolute Values of LAA-950 at Month 30 | 1.977 % of voxels with attenuation <=-950 HU | Standard Deviation 2.0639 |
| Participants With COPD - GOLD Grade III | Sub-cohort: Absolute Values of LAA-950 at Month 30 | 0.360 % of voxels with attenuation <=-950 HU | Standard Deviation 0.5297 |
Secondary
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)
Population: Sub-cohort Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With COPD - GOLD Grade I | Sub-cohort: Absolute Values of Low Attenuation Area -950 (LAA-950) at Baseline | 8.378 % of voxels with attenuation <=-950 HU | Standard Deviation 8.4787 |
| Participants With COPD - GOLD Grade II | Sub-cohort: Absolute Values of Low Attenuation Area -950 (LAA-950) at Baseline | 1.707 % of voxels with attenuation <=-950 HU | Standard Deviation 2.3429 |
| Participants With COPD - GOLD Grade III | Sub-cohort: Absolute Values of Low Attenuation Area -950 (LAA-950) at Baseline | 0.295 % of voxels with attenuation <=-950 HU | Standard Deviation 0.3556 |
Secondary
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)
Population: Sub-cohort Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With COPD - GOLD Grade I | Sub-cohort: Absolute Values of Perimeter of 10 Millimeter (mm) (Pi10) at Baseline | 3.892 Millimeter | Standard Deviation 0.1361 |
| Participants With COPD - GOLD Grade II | Sub-cohort: Absolute Values of Perimeter of 10 Millimeter (mm) (Pi10) at Baseline | 3.917 Millimeter | Standard Deviation 0.1318 |
| Participants With COPD - GOLD Grade III | Sub-cohort: Absolute Values of Perimeter of 10 Millimeter (mm) (Pi10) at Baseline | 3.905 Millimeter | Standard Deviation 0.1367 |
Secondary
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
Population: Sub-cohort Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With COPD - GOLD Grade I | Sub-cohort: Absolute Values of Pi10 at Month 30 | 3.836 Millimeter | Standard Deviation 0.1571 |
| Participants With COPD - GOLD Grade II | Sub-cohort: Absolute Values of Pi10 at Month 30 | 3.860 Millimeter | Standard Deviation 0.1826 |
| Participants With COPD - GOLD Grade III | Sub-cohort: Absolute Values of Pi10 at Month 30 | 3.842 Millimeter | Standard Deviation 0.1163 |
Secondary
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)
Population: Sub-cohort Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With COPD - GOLD Grade I | 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 | Serum IP-10 | 41.193 Picogram per milliliter | Standard Deviation 45.1502 |
| Participants With COPD - GOLD Grade I | 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 | Serum sRAGE | 907.135 Picogram per milliliter | Standard Deviation 506.1643 |
| Participants With COPD - GOLD Grade II | 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 | Serum IP-10 | 36.025 Picogram per milliliter | Standard Deviation 34.8718 |
| Participants With COPD - GOLD Grade II | 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 | Serum sRAGE | 993.892 Picogram per milliliter | Standard Deviation 655.1966 |
| Participants With COPD - GOLD Grade III | 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 | Serum IP-10 | 48.524 Picogram per milliliter | Standard Deviation 50.193 |
| Participants With COPD - GOLD Grade III | 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 | Serum sRAGE | 1101.124 Picogram per milliliter | Standard Deviation 551.824 |
Secondary
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
Population: Sub-cohort Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With COPD - GOLD Grade I | Sub-cohort: Absolute Values of Serum IP-10 and Serum sRAGE at Month 30 | Serum IP-10 | 54.435 Picogram per milliliter | Standard Deviation 83.4309 |
| Participants With COPD - GOLD Grade I | Sub-cohort: Absolute Values of Serum IP-10 and Serum sRAGE at Month 30 | Serum sRAGE | 1046.746 Picogram per milliliter | Standard Deviation 632.6992 |
| Participants With COPD - GOLD Grade II | Sub-cohort: Absolute Values of Serum IP-10 and Serum sRAGE at Month 30 | Serum IP-10 | 53.711 Picogram per milliliter | Standard Deviation 51.1595 |
| Participants With COPD - GOLD Grade II | Sub-cohort: Absolute Values of Serum IP-10 and Serum sRAGE at Month 30 | Serum sRAGE | 1287.528 Picogram per milliliter | Standard Deviation 905.2041 |
| Participants With COPD - GOLD Grade III | Sub-cohort: Absolute Values of Serum IP-10 and Serum sRAGE at Month 30 | Serum IP-10 | 35.103 Picogram per milliliter | Standard Deviation 20.8046 |
| Participants With COPD - GOLD Grade III | Sub-cohort: Absolute Values of Serum IP-10 and Serum sRAGE at Month 30 | Serum sRAGE | 1166.739 Picogram per milliliter | Standard Deviation 608.905 |
Secondary
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)
Population: Sub-cohort Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With COPD - GOLD Grade I | Sub-cohort: Absolute Values of Total Cell Count of Sputum Sample at Baseline | 545.981 Cells per milliliter | Standard Deviation 379.7851 |
| Participants With COPD - GOLD Grade II | Sub-cohort: Absolute Values of Total Cell Count of Sputum Sample at Baseline | 529.603 Cells per milliliter | Standard Deviation 611.6267 |
Secondary
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
Population: Sub-cohort Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With COPD - GOLD Grade I | Sub-cohort: Absolute Values of Total Cell Count of Sputum Sample at Month 30 | 766.888 Cells per milliliter | Standard Deviation 1005.417 |
| Participants With COPD - GOLD Grade II | Sub-cohort: Absolute Values of Total Cell Count of Sputum Sample at Month 30 | 550.053 Cells per milliliter | Standard Deviation 557.1129 |
| Participants With COPD - GOLD Grade III | Sub-cohort: Absolute Values of Total Cell Count of Sputum Sample at Month 30 | 835.903 Cells per milliliter | Standard Deviation 511.9084 |
Secondary
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)
Population: Sub-cohort Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With COPD - GOLD Grade I | Sub-cohort: Air Volume Ratio (RV/TLC) at Baseline | 62.821 % of air volume at FI remaining after FE | Standard Deviation 15.3924 |
| Participants With COPD - GOLD Grade II | Sub-cohort: Air Volume Ratio (RV/TLC) at Baseline | 48.535 % of air volume at FI remaining after FE | Standard Deviation 15.507 |
| Participants With COPD - GOLD Grade III | Sub-cohort: Air Volume Ratio (RV/TLC) at Baseline | 45.617 % of air volume at FI remaining after FE | Standard Deviation 13.2394 |
Secondary
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
Population: Sub-cohort Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With COPD - GOLD Grade I | Sub-cohort: Air Volume Ratio (RV/TLC) at Month 30 | 61.276 % of air volume at FI remaining after FE | Standard Deviation 12.9739 |
| Participants With COPD - GOLD Grade II | Sub-cohort: Air Volume Ratio (RV/TLC) at Month 30 | 48.906 % of air volume at FI remaining after FE | Standard Deviation 12.0766 |
| Participants With COPD - GOLD Grade III | Sub-cohort: Air Volume Ratio (RV/TLC) at Month 30 | 51.562 % of air volume at FI remaining after FE | Standard Deviation 13.4382 |
Secondary
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)
Population: Sub-cohort Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With COPD - GOLD Grade I | Sub-cohort: Average of Airway Major Inner Diameter at Baseline | 5.505 Millimeter | Standard Deviation 0.9841 |
| Participants With COPD - GOLD Grade II | Sub-cohort: Average of Airway Major Inner Diameter at Baseline | 5.619 Millimeter | Standard Deviation 0.7687 |
| Participants With COPD - GOLD Grade III | Sub-cohort: Average of Airway Major Inner Diameter at Baseline | 5.301 Millimeter | Standard Deviation 0.8259 |
Secondary
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
Population: Sub-cohort Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With COPD - GOLD Grade I | Sub-cohort: Average of Airway Major Inner Diameter at Month 30 | 5.371 Millimeter | Standard Deviation 0.8963 |
| Participants With COPD - GOLD Grade II | Sub-cohort: Average of Airway Major Inner Diameter at Month 30 | 5.536 Millimeter | Standard Deviation 0.8258 |
| Participants With COPD - GOLD Grade III | Sub-cohort: Average of Airway Major Inner Diameter at Month 30 | 5.128 Millimeter | Standard Deviation 1.0098 |
Secondary
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)
Population: Sub-cohort Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With COPD - GOLD Grade I | Sub-cohort: Average of Airway Minor Inner Diameter at Baseline | 4.058 Millimeter | Standard Deviation 0.6732 |
| Participants With COPD - GOLD Grade II | Sub-cohort: Average of Airway Minor Inner Diameter at Baseline | 4.222 Millimeter | Standard Deviation 0.605 |
| Participants With COPD - GOLD Grade III | Sub-cohort: Average of Airway Minor Inner Diameter at Baseline | 3.973 Millimeter | Standard Deviation 0.5335 |
Secondary
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
Population: Sub-cohort Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With COPD - GOLD Grade I | Sub-cohort: Average of Airway Minor Inner Diameter at Month 30 | 3.969 Millimeter | Standard Deviation 0.6694 |
| Participants With COPD - GOLD Grade II | Sub-cohort: Average of Airway Minor Inner Diameter at Month 30 | 4.174 Millimeter | Standard Deviation 0.6569 |
| Participants With COPD - GOLD Grade III | Sub-cohort: Average of Airway Minor Inner Diameter at Month 30 | 3.804 Millimeter | Standard Deviation 0.5863 |
Secondary
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
Population: Sub-cohort Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With COPD - GOLD Grade I | Sub-cohort: Change From Baseline in E-RS:COPD Total Scores From Months 18 to 24 | 1.735 Scores on a scale | Standard Deviation 4.6876 |
| Participants With COPD - GOLD Grade II | Sub-cohort: Change From Baseline in E-RS:COPD Total Scores From Months 18 to 24 | 1.014 Scores on a scale | Standard Deviation 4.3033 |
| Participants With COPD - GOLD Grade III | Sub-cohort: Change From Baseline in E-RS:COPD Total Scores From Months 18 to 24 | 0.086 Scores on a scale | Standard Deviation 1.3097 |
Secondary
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
Population: Sub-cohort Population consisted of participants who were enrolled in the Biomarker and Digital sub-cohort and who provided a least one additional sub-cohort assessment. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With COPD - GOLD Grade I | Sub-cohort: Change From Baseline in Evaluating Respiratory Symptoms in COPD (E-RS:COPD) Total Scores From Months 1 to 6 | 0.697 Scores on a scale | Standard Deviation 3.6181 |
| Participants With COPD - GOLD Grade II | Sub-cohort: Change From Baseline in Evaluating Respiratory Symptoms in COPD (E-RS:COPD) Total Scores From Months 1 to 6 | -0.018 Scores on a scale | Standard Deviation 2.8032 |
| Participants With COPD - GOLD Grade III | Sub-cohort: Change From Baseline in Evaluating Respiratory Symptoms in COPD (E-RS:COPD) Total Scores From Months 1 to 6 | 0.020 Scores on a scale | Standard Deviation 1.2256 |
Secondary
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)
Population: Sub-cohort Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With COPD - GOLD Grade I | Sub-cohort: Computed Tomography (CT) Attenuation at the 15th Percentile of the Lung CT Histogram (Perc15) in Residual Volume at Baseline | -893.654 Hounsfield Unit | Standard Deviation 36.9708 |
| Participants With COPD - GOLD Grade II | Sub-cohort: Computed Tomography (CT) Attenuation at the 15th Percentile of the Lung CT Histogram (Perc15) in Residual Volume at Baseline | -829.016 Hounsfield Unit | Standard Deviation 41.3549 |
| Participants With COPD - GOLD Grade III | Sub-cohort: Computed Tomography (CT) Attenuation at the 15th Percentile of the Lung CT Histogram (Perc15) in Residual Volume at Baseline | -804.517 Hounsfield Unit | Standard Deviation 41.8978 |
Secondary
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
Population: Sub-cohort Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants With COPD - GOLD Grade I | Sub-cohort: Number of Participants With Exacerbation of COPD Tool (EXACT) Events From Months 1 to 6 | 59 Participants |
| Participants With COPD - GOLD Grade II | Sub-cohort: Number of Participants With Exacerbation of COPD Tool (EXACT) Events From Months 1 to 6 | 12 Participants |
| Participants With COPD - GOLD Grade III | Sub-cohort: Number of Participants With Exacerbation of COPD Tool (EXACT) Events From Months 1 to 6 | 1 Participants |
Secondary
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
Population: Sub-cohort Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants With COPD - GOLD Grade I | Sub-cohort: Number of Participants With EXACT Events From Months 18 to 24 | 55 Participants |
| Participants With COPD - GOLD Grade II | Sub-cohort: Number of Participants With EXACT Events From Months 18 to 24 | 13 Participants |
| Participants With COPD - GOLD Grade III | Sub-cohort: Number of Participants With EXACT Events From Months 18 to 24 | 0 Participants |
Secondary
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
Population: Sub-cohort Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With COPD - GOLD Grade I | Sub-cohort: Perc15 in Residual Volume at Month 30 | -900.234 Hounsfield Unit | Standard Deviation 35.0697 |
| Participants With COPD - GOLD Grade II | Sub-cohort: Perc15 in Residual Volume at Month 30 | -840.501 Hounsfield Unit | Standard Deviation 36.8535 |
| Participants With COPD - GOLD Grade III | Sub-cohort: Perc15 in Residual Volume at Month 30 | -825.538 Hounsfield Unit | Standard Deviation 40.4339 |
Secondary
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)
Population: Sub-cohort Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With COPD - GOLD Grade I | Sub-cohort: Perc15 in Total Lung Capacity at Baseline | -929.370 Hounsfield Unit | Standard Deviation 23.0575 |
| Participants With COPD - GOLD Grade II | Sub-cohort: Perc15 in Total Lung Capacity at Baseline | -903.261 Hounsfield Unit | Standard Deviation 23.9101 |
| Participants With COPD - GOLD Grade III | Sub-cohort: Perc15 in Total Lung Capacity at Baseline | -885.743 Hounsfield Unit | Standard Deviation 22.2715 |
Secondary
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
Population: Sub-cohort Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With COPD - GOLD Grade I | Sub-cohort: Perc15 in Total Lung Capacity at Month 30 | -933.063 Hounsfield Unit | Standard Deviation 24.9625 |
| Participants With COPD - GOLD Grade II | Sub-cohort: Perc15 in Total Lung Capacity at Month 30 | -908.850 Hounsfield Unit | Standard Deviation 20.045 |
| Participants With COPD - GOLD Grade III | Sub-cohort: Perc15 in Total Lung Capacity at Month 30 | -878.913 Hounsfield Unit | Standard Deviation 32.5519 |
Secondary
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
Population: Sub-cohort Population. 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.
Secondary
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)
Population: Sub-cohort Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With COPD - GOLD Grade I | Sub-cohort: Total Airway Count at Baseline | 353.5 Airway Segments | Standard Deviation 123.77 |
| Participants With COPD - GOLD Grade II | Sub-cohort: Total Airway Count at Baseline | 430.9 Airway Segments | Standard Deviation 144.01 |
| Participants With COPD - GOLD Grade III | Sub-cohort: Total Airway Count at Baseline | 352.0 Airway Segments | Standard Deviation 122.89 |
Secondary
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
Population: Sub-cohort Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With COPD - GOLD Grade I | Sub-cohort: Total Airway Count at Month 30 | 425.8 Airway Segments | Standard Deviation 174.59 |
| Participants With COPD - GOLD Grade II | Sub-cohort: Total Airway Count at Month 30 | 542.9 Airway Segments | Standard Deviation 183.86 |
| Participants With COPD - GOLD Grade III | Sub-cohort: Total Airway Count at Month 30 | 392.9 Airway Segments | Standard Deviation 193.63 |