Trial Outcomes & Findings for Investigation of Chronic Obstructive Pulmonary Disease (COPD) Phenotypes and Endotypes in China (NCT NCT04853225)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

2005 participants

Primary outcome timeframe

Baseline (Day 1 of Month 1) and at Month 30

Results posted on

2025-08-20

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.	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.	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.
Overall Study STARTED	1698	184	123
Overall Study Full Population	1696	184	123
Overall Study COMPLETED	1451	165	116
Overall Study NOT COMPLETED	247	19	7

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.	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.
Overall Study Withdrawal by Subject	81	4	1
Overall Study Physician Decision	12	4	1
Overall Study Lost to Follow-up	50	0	0
Overall Study Other	102	11	5
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

Baseline Characteristics

Investigation of Chronic Obstructive Pulmonary Disease (COPD) Phenotypes and Endotypes in China

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	COPD Participants n=1696 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.	Participants With Chronic Bronchitis n=184 Participants Participants with chronic bronchitis were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Never Smoker Healthy Control n=123 Participants Never smoker healthy participants were enrolled in this control cohort. No study treatment was administered during conduct of this non-interventional study.	Total n=2003 Participants Total of all reporting groups
Age, Continuous	65.4 Years STANDARD_DEVIATION 7.46 • n=5 Participants	61.3 Years STANDARD_DEVIATION 7.16 • n=7 Participants	58.7 Years STANDARD_DEVIATION 6.72 • n=5 Participants	64.6 Years STANDARD_DEVIATION 7.63 • n=4 Participants
Sex: Female, Male Female	176 Participants n=5 Participants	24 Participants n=7 Participants	82 Participants n=5 Participants	282 Participants n=4 Participants
Sex: Female, Male Male	1520 Participants n=5 Participants	160 Participants n=7 Participants	41 Participants n=5 Participants	1721 Participants n=4 Participants
Race/Ethnicity, Customized Asian - East Asian Heritage	1696 Participants n=5 Participants	184 Participants n=7 Participants	123 Participants n=5 Participants	2003 Participants n=4 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Participants With COPD - GOLD Grade I n=302 Participants Participants with COPD classified using the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Grade I (mild COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade II n=644 Participants Participants with COPD classified using the GOLD Grade II (moderate COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade III n=148 Participants Participants with COPD classified using the GOLD Grade III (severe COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade IV n=44 Participants Participants with COPD classified using the GOLD Grade IV (very severe COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With Chronic Bronchitis n=108 Participants Participants with chronic bronchitis were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Never Smoker Healthy Control n=78 Participants Never smoker healthy participants were enrolled in this control cohort. No study treatment was administered during conduct of this non-interventional study.
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	-93.9 Milliliter Standard Deviation 271.65	-1.2 Milliliter Standard Deviation 226.44	-17.3 Milliliter Standard Deviation 141.54	-144.4 Milliliter Standard Deviation 250.50	-53.6 Milliliter Standard Deviation 222.51
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	-107.4 Milliliter Standard Deviation 250.66	-34.7 Milliliter Standard Deviation 207.13	-33.6 Milliliter Standard Deviation 138.98	-148.2 Milliliter Standard Deviation 229.19	-77.2 Milliliter Standard Deviation 200.51

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Participants With COPD - GOLD Grade I n=302 Participants Participants with COPD classified using the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Grade I (mild COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade II n=644 Participants Participants with COPD classified using the GOLD Grade II (moderate COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade III n=148 Participants Participants with COPD classified using the GOLD Grade III (severe COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade IV n=44 Participants Participants with COPD classified using the GOLD Grade IV (very severe COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With Chronic Bronchitis n=108 Participants Participants with chronic bronchitis were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Never Smoker Healthy Control n=78 Participants Never smoker healthy participants were enrolled in this control cohort. No study treatment was administered during conduct of this non-interventional study.
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	-161.0 Milliliter Standard Deviation 351.83	-58.6 Milliliter Standard Deviation 402.70	-27.3 Milliliter Standard Deviation 352.13	-139.8 Milliliter Standard Deviation 302.96	-26.4 Milliliter Standard Deviation 264.49
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	-170.5 Milliliter Standard Deviation 332.35	-115.8 Milliliter Standard Deviation 344.63	-101.6 Milliliter Standard Deviation 302.39	-114.0 Milliliter Standard Deviation 273.44	-81.9 Milliliter Standard Deviation 227.64

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Participants With COPD - GOLD Grade I n=438 Participants Participants with COPD classified using the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Grade I (mild COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade II n=937 Participants Participants with COPD classified using the GOLD Grade II (moderate COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade III n=223 Participants Participants with COPD classified using the GOLD Grade III (severe COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade IV n=98 Participants Participants with COPD classified using the GOLD Grade IV (very severe COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With Chronic Bronchitis n=184 Participants Participants with chronic bronchitis were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	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.
Main Cohort: Rate of Moderate/Severe Exacerbations in COPD and Chronic Bronchitis Cohorts	0.08 Exacerbations per participant per year Interval 0.06 to 0.1	0.12 Exacerbations per participant per year Interval 0.11 to 0.14	0.26 Exacerbations per participant per year Interval 0.21 to 0.33	0.35 Exacerbations per participant per year Interval 0.25 to 0.49	0.02 Exacerbations per participant per year Interval 0.01 to 0.04	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Participants With COPD - GOLD Grade I n=1437 Participants Participants with COPD classified using the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Grade I (mild COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade II n=164 Participants Participants with COPD classified using the GOLD Grade II (moderate COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade III n=116 Participants Participants with COPD classified using the GOLD Grade III (severe COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade IV Participants with COPD classified using the GOLD Grade IV (very severe COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	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.	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.
Main Cohort: Change From Baseline in COPD Assessment Test (CAT) Score at Month 30	-0.9 Scores on a scale Standard Deviation 5.84	-2.3 Scores on a scale Standard Deviation 5.45	0.3 Scores on a scale Standard Deviation 2.46	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Participants With COPD - GOLD Grade I n=1437 Participants Participants with COPD classified using the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Grade I (mild COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade II n=164 Participants Participants with COPD classified using the GOLD Grade II (moderate COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade III n=116 Participants Participants with COPD classified using the GOLD Grade III (severe COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade IV Participants with COPD classified using the GOLD Grade IV (very severe COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	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.	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.
Main Cohort: Absolute Values of CAT Score at Month 30	7.5 Scores on a scale Standard Deviation 5.33	5.7 Scores on a scale Standard Deviation 4.18	1.3 Scores on a scale Standard Deviation 2.36	—	—	—

SECONDARY outcome

Timeframe: At Baseline (Day 1 of Month 1)

Population: Full Population.

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.

Outcome measures

Outcome measures
Measure	Participants With COPD - GOLD Grade I n=1696 Participants Participants with COPD classified using the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Grade I (mild COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade II n=184 Participants Participants with COPD classified using the GOLD Grade II (moderate COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade III n=123 Participants Participants with COPD classified using the GOLD Grade III (severe COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade IV Participants with COPD classified using the GOLD Grade IV (very severe COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	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.	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.
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	2.0 Scores on a scale Standard Deviation 1.37	0.3 Scores on a scale Standard Deviation 0.55	—	—	—

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Participants With COPD - GOLD Grade I n=1524 Participants Participants with COPD classified using the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Grade I (mild COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade II n=168 Participants Participants with COPD classified using the GOLD Grade II (moderate COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade III n=117 Participants Participants with COPD classified using the GOLD Grade III (severe COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade IV Participants with COPD classified using the GOLD Grade IV (very severe COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	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.	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.
Main Cohort: Total Score of CAPTURE at Month 18	2.5 Scores on a scale Standard Deviation 1.48	1.8 Scores on a scale Standard Deviation 1.49	0.4 Scores on a scale Standard Deviation 0.69	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Participants With COPD - GOLD Grade I n=1618 Participants Participants with COPD classified using the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Grade I (mild COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade II n=173 Participants Participants with COPD classified using the GOLD Grade II (moderate COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade III n=122 Participants Participants with COPD classified using the GOLD Grade III (severe COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade IV Participants with COPD classified using the GOLD Grade IV (very severe COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	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.	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.
Main Cohort: Number of Participants With Any Clinically Important Deterioration (CID) Event and Its Components From Baseline to Month 6 Any CID	897 Participants	90 Participants	58 Participants	—	—	—
Main Cohort: Number of Participants With Any Clinically Important Deterioration (CID) Event and Its Components From Baseline to Month 6 Exacerbation CID	153 Participants	1 Participants	0 Participants	—	—	—
Main Cohort: Number of Participants With Any Clinically Important Deterioration (CID) Event and Its Components From Baseline to Month 6 FEV1 CID	431 Participants	55 Participants	36 Participants	—	—	—
Main Cohort: Number of Participants With Any Clinically Important Deterioration (CID) Event and Its Components From Baseline to Month 6 CAT CID	567 Participants	53 Participants	31 Participants	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Participants With COPD - GOLD Grade I n=1538 Participants Participants with COPD classified using the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Grade I (mild COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade II n=169 Participants Participants with COPD classified using the GOLD Grade II (moderate COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade III n=117 Participants Participants with COPD classified using the GOLD Grade III (severe COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade IV Participants with COPD classified using the GOLD Grade IV (very severe COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	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.	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.
Main Cohort: Number of Participants With Any CID Event and Its Components From Months 6 to 18 Any CID	1120 Participants	97 Participants	82 Participants	—	—	—
Main Cohort: Number of Participants With Any CID Event and Its Components From Months 6 to 18 Exacerbation CID	211 Participants	0 Participants	0 Participants	—	—	—
Main Cohort: Number of Participants With Any CID Event and Its Components From Months 6 to 18 FEV1 CID	524 Participants	64 Participants	42 Participants	—	—	—
Main Cohort: Number of Participants With Any CID Event and Its Components From Months 6 to 18 CAT CID	794 Participants	52 Participants	60 Participants	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Participants With COPD - GOLD Grade I n=1452 Participants Participants with COPD classified using the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Grade I (mild COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade II n=165 Participants Participants with COPD classified using the GOLD Grade II (moderate COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade III n=116 Participants Participants with COPD classified using the GOLD Grade III (severe COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade IV Participants with COPD classified using the GOLD Grade IV (very severe COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	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.	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.
Main Cohort: Number of Participants With Any CID Event and Its Components From Months 18 to 30 Any CID	1086 Participants	93 Participants	68 Participants	—	—	—
Main Cohort: Number of Participants With Any CID Event and Its Components From Months 18 to 30 Exacerbation CID	177 Participants	2 Participants	0 Participants	—	—	—
Main Cohort: Number of Participants With Any CID Event and Its Components From Months 18 to 30 FEV1 CID	594 Participants	61 Participants	37 Participants	—	—	—
Main Cohort: Number of Participants With Any CID Event and Its Components From Months 18 to 30 CAT CID	771 Participants	54 Participants	48 Participants	—	—	—

SECONDARY outcome

Timeframe: Up to 30 months

Population: Full Population.

Number of participants who died during study have been presented.

Outcome measures

Outcome measures
Measure	Participants With COPD - GOLD Grade I n=1696 Participants Participants with COPD classified using the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Grade I (mild COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade II n=184 Participants Participants with COPD classified using the GOLD Grade II (moderate COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade III n=123 Participants Participants with COPD classified using the GOLD Grade III (severe COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade IV Participants with COPD classified using the GOLD Grade IV (very severe COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	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.	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.
Main Cohort: Number of Participants Who Died	41 Participants	2 Participants	0 Participants	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Participants With COPD - GOLD Grade I n=245 Participants Participants with COPD classified using the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Grade I (mild COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade II n=95 Participants Participants with COPD classified using the GOLD Grade II (moderate COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade III n=53 Participants Participants with COPD classified using the GOLD Grade III (severe COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade IV Participants with COPD classified using the GOLD Grade IV (very severe COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	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.	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.
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	-0.018 Scores on a scale Standard Deviation 2.8032	0.020 Scores on a scale Standard Deviation 1.2256	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Participants With COPD - GOLD Grade I n=178 Participants Participants with COPD classified using the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Grade I (mild COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade II n=70 Participants Participants with COPD classified using the GOLD Grade II (moderate COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade III n=41 Participants Participants with COPD classified using the GOLD Grade III (severe COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade IV Participants with COPD classified using the GOLD Grade IV (very severe COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	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.	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.
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	1.014 Scores on a scale Standard Deviation 4.3033	0.086 Scores on a scale Standard Deviation 1.3097	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Participants With COPD - GOLD Grade I n=245 Participants Participants with COPD classified using the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Grade I (mild COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade II n=95 Participants Participants with COPD classified using the GOLD Grade II (moderate COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade III n=53 Participants Participants with COPD classified using the GOLD Grade III (severe COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade IV Participants with COPD classified using the GOLD Grade IV (very severe COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	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.	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.
Sub-cohort: Number of Participants With Exacerbation of COPD Tool (EXACT) Events From Months 1 to 6	59 Participants	12 Participants	1 Participants	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Participants With COPD - GOLD Grade I n=178 Participants Participants with COPD classified using the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Grade I (mild COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade II n=70 Participants Participants with COPD classified using the GOLD Grade II (moderate COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade III n=41 Participants Participants with COPD classified using the GOLD Grade III (severe COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade IV Participants with COPD classified using the GOLD Grade IV (very severe COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	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.	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.
Sub-cohort: Number of Participants With EXACT Events From Months 18 to 24	55 Participants	13 Participants	0 Participants	—	—	—

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Participants With COPD - GOLD Grade I n=211 Participants Participants with COPD classified using the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Grade I (mild COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade II n=85 Participants Participants with COPD classified using the GOLD Grade II (moderate COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade III n=49 Participants Participants with COPD classified using the GOLD Grade III (severe COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade IV Participants with COPD classified using the GOLD Grade IV (very severe COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	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.	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.
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	8743.2 Steps per day Standard Deviation 3750.53	12063.6 Steps per day Standard Deviation 4152.42	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Participants With COPD - GOLD Grade I n=220 Participants Participants with COPD classified using the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Grade I (mild COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade II n=87 Participants Participants with COPD classified using the GOLD Grade II (moderate COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade III n=52 Participants Participants with COPD classified using the GOLD Grade III (severe COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade IV Participants with COPD classified using the GOLD Grade IV (very severe COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	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.	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.
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	9284.5 Steps per day Standard Deviation 4011.25	12790.5 Steps per day Standard Deviation 4233.32	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Participants With COPD - GOLD Grade I n=170 Participants Participants with COPD classified using the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Grade I (mild COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade II n=63 Participants Participants with COPD classified using the GOLD Grade II (moderate COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade III n=31 Participants Participants with COPD classified using the GOLD Grade III (severe COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade IV Participants with COPD classified using the GOLD Grade IV (very severe COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	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.	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.
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	6454.3 Steps per day Standard Deviation 3207.73	7495.4 Steps per day Standard Deviation 4723.39	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Participants With COPD - GOLD Grade I n=1694 Participants Participants with COPD classified using the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Grade I (mild COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade II n=183 Participants Participants with COPD classified using the GOLD Grade II (moderate COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade III n=123 Participants Participants with COPD classified using the GOLD Grade III (severe COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade IV Participants with COPD classified using the GOLD Grade IV (very severe COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	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.	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.
Main Cohort: Absolute Values of Plasma Fibrinogen at Baseline	337.1 Milligram per deciliter Standard Deviation 82.59	315.8 Milligram per deciliter Standard Deviation 89.97	304.4 Milligram per deciliter Standard Deviation 73.36	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Participants With COPD - GOLD Grade I n=1273 Participants Participants with COPD classified using the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Grade I (mild COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade II n=139 Participants Participants with COPD classified using the GOLD Grade II (moderate COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade III n=102 Participants Participants with COPD classified using the GOLD Grade III (severe COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade IV Participants with COPD classified using the GOLD Grade IV (very severe COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	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.	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.
Main Cohort: Absolute Values of Plasma Fibrinogen at Month 30	341.2 Milligram per deciliter Standard Deviation 82.94	328.4 Milligram per deciliter Standard Deviation 66.10	315.9 Milligram per deciliter Standard Deviation 63.01	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Participants With COPD - GOLD Grade I n=1695 Participants Participants with COPD classified using the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Grade I (mild COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade II n=183 Participants Participants with COPD classified using the GOLD Grade II (moderate COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade III n=122 Participants Participants with COPD classified using the GOLD Grade III (severe COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade IV Participants with COPD classified using the GOLD Grade IV (very severe COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	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.	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.
Main Cohort: Absolute Values of C-Reactive Protein at Baseline	0.2791 Milligram per deciliter Standard Deviation 0.68530	0.2463 Milligram per deciliter Standard Deviation 0.93353	0.1654 Milligram per deciliter Standard Deviation 0.40848	—	—	—

SECONDARY outcome

Timeframe: 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.

Blood samples were collected for the analysis of C-Reactive Protein.

Outcome measures

Outcome measures
Measure	Participants With COPD - GOLD Grade I n=1272 Participants Participants with COPD classified using the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Grade I (mild COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade II n=139 Participants Participants with COPD classified using the GOLD Grade II (moderate COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade III n=102 Participants Participants with COPD classified using the GOLD Grade III (severe COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade IV Participants with COPD classified using the GOLD Grade IV (very severe COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	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.	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.
Main Cohort: Absolute Values of C-Reactive Protein at Month 30	0.3411 Milligram per deciliter Standard Deviation 0.71558	0.2734 Milligram per deciliter Standard Deviation 0.63660	0.1645 Milligram per deciliter Standard Deviation 0.20928	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Participants With COPD - GOLD Grade I n=1693 Participants Participants with COPD classified using the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Grade I (mild COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade II n=182 Participants Participants with COPD classified using the GOLD Grade II (moderate COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade III n=120 Participants Participants with COPD classified using the GOLD Grade III (severe COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade IV Participants with COPD classified using the GOLD Grade IV (very severe COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	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.	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.
Main Cohort: Absolute Values of Eosinophils and Neutrophils at Baseline Eosinophils	0.231 Giga cells per liter Standard Deviation 0.2084	0.199 Giga cells per liter Standard Deviation 0.1711	0.109 Giga cells per liter Standard Deviation 0.1006	—	—	—
Main Cohort: Absolute Values of Eosinophils and Neutrophils at Baseline Neutrophils	4.467 Giga cells per liter Standard Deviation 1.6253	4.180 Giga cells per liter Standard Deviation 1.5366	3.810 Giga cells per liter Standard Deviation 0.9967	—	—	—

SECONDARY outcome

Timeframe: 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.

Blood samples were collected for the analysis of eosinophils and neutrophils.

Outcome measures

Outcome measures
Measure	Participants With COPD - GOLD Grade I n=1269 Participants Participants with COPD classified using the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Grade I (mild COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade II n=139 Participants Participants with COPD classified using the GOLD Grade II (moderate COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade III n=102 Participants Participants with COPD classified using the GOLD Grade III (severe COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade IV Participants with COPD classified using the GOLD Grade IV (very severe COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	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.	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.
Main Cohort: Absolute Values of Eosinophils and Neutrophils at Month 30 Eosinophils	0.267 Giga cells per liter Standard Deviation 0.2921	0.228 Giga cells per liter Standard Deviation 0.2351	0.145 Giga cells per liter Standard Deviation 0.1853	—	—	—
Main Cohort: Absolute Values of Eosinophils and Neutrophils at Month 30 Neutrophils	4.516 Giga cells per liter Standard Deviation 1.6207	4.198 Giga cells per liter Standard Deviation 1.6725	3.667 Giga cells per liter Standard Deviation 1.0537	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Participants With COPD - GOLD Grade I n=1693 Participants Participants with COPD classified using the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Grade I (mild COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade II n=182 Participants Participants with COPD classified using the GOLD Grade II (moderate COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade III n=120 Participants Participants with COPD classified using the GOLD Grade III (severe COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade IV Participants with COPD classified using the GOLD Grade IV (very severe COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	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.	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.
Main Cohort: Absolute Values of Hemoglobin at Baseline	142.2 Grams per liter Standard Deviation 13.03	141.6 Grams per liter Standard Deviation 11.90	132.7 Grams per liter Standard Deviation 15.03	—	—	—

SECONDARY outcome

Timeframe: 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.

Blood samples were collected for the analysis of hemoglobin.

Outcome measures

Outcome measures
Measure	Participants With COPD - GOLD Grade I n=1269 Participants Participants with COPD classified using the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Grade I (mild COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade II n=139 Participants Participants with COPD classified using the GOLD Grade II (moderate COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade III n=102 Participants Participants with COPD classified using the GOLD Grade III (severe COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade IV Participants with COPD classified using the GOLD Grade IV (very severe COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	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.	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.
Main Cohort: Absolute Values of Hemoglobin at Months 30	143.4 Grams per liter Standard Deviation 13.50	144.3 Grams per liter Standard Deviation 12.29	135.3 Grams per liter Standard Deviation 12.97	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Participants With COPD - GOLD Grade I n=249 Participants Participants with COPD classified using the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Grade I (mild COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade II n=98 Participants Participants with COPD classified using the GOLD Grade II (moderate COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade III n=52 Participants Participants with COPD classified using the GOLD Grade III (severe COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade IV Participants with COPD classified using the GOLD Grade IV (very severe COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	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.	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.
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	36.025 Picogram per milliliter Standard Deviation 34.8718	48.524 Picogram per milliliter Standard Deviation 50.1930	—	—	—
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	993.892 Picogram per milliliter Standard Deviation 655.1966	1101.124 Picogram per milliliter Standard Deviation 551.8240	—	—	—

SECONDARY outcome

Timeframe: 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.

Blood samples were collected at Month 30 for the analysis of blood biomarkers serum IP-10 and serum sRAGE.

Outcome measures

Outcome measures
Measure	Participants With COPD - GOLD Grade I n=188 Participants Participants with COPD classified using the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Grade I (mild COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade II n=72 Participants Participants with COPD classified using the GOLD Grade II (moderate COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade III n=42 Participants Participants with COPD classified using the GOLD Grade III (severe COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade IV Participants with COPD classified using the GOLD Grade IV (very severe COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	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.	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.
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	53.711 Picogram per milliliter Standard Deviation 51.1595	35.103 Picogram per milliliter Standard Deviation 20.8046	—	—	—
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	1287.528 Picogram per milliliter Standard Deviation 905.2041	1166.739 Picogram per milliliter Standard Deviation 608.9050	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Participants With COPD - GOLD Grade I n=251 Participants Participants with COPD classified using the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Grade I (mild COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade II n=99 Participants Participants with COPD classified using the GOLD Grade II (moderate COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade III n=52 Participants Participants with COPD classified using the GOLD Grade III (severe COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade IV Participants with COPD classified using the GOLD Grade IV (very severe COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	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.	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.
Sub-cohort: Absolute Values of Club Cell Protein (CC16) at Baseline	8.8512 Nanogram per milliliter Standard Deviation 6.80359	9.2704 Nanogram per milliliter Standard Deviation 7.29006	7.8313 Nanogram per milliliter Standard Deviation 5.76284	—	—	—

SECONDARY outcome

Timeframe: 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.

Blood samples were collected for the analysis of blood biomarker CC16.

Outcome measures

Outcome measures
Measure	Participants With COPD - GOLD Grade I n=188 Participants Participants with COPD classified using the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Grade I (mild COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade II n=72 Participants Participants with COPD classified using the GOLD Grade II (moderate COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade III n=42 Participants Participants with COPD classified using the GOLD Grade III (severe COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade IV Participants with COPD classified using the GOLD Grade IV (very severe COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	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.	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.
Sub-cohort: Absolute Values of CC16 at Month 30	15.2812 Nanogram per milliliter Standard Deviation 10.90814	15.5412 Nanogram per milliliter Standard Deviation 10.78253	14.4739 Nanogram per milliliter Standard Deviation 8.45046	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Participants With COPD - GOLD Grade I n=251 Participants Participants with COPD classified using the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Grade I (mild COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade II n=99 Participants Participants with COPD classified using the GOLD Grade II (moderate COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade III n=53 Participants Participants with COPD classified using the GOLD Grade III (severe COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade IV Participants with COPD classified using the GOLD Grade IV (very severe COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	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.	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.
Sub-cohort: Absolute Values of Glycated Hemoglobin A1c (HbA1c) at Baseline	5.68 Percentage of HbA1c in blood Standard Deviation 0.660	5.87 Percentage of HbA1c in blood Standard Deviation 0.989	5.66 Percentage of HbA1c in blood Standard Deviation 0.901	—	—	—

SECONDARY outcome

Timeframe: 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.

Blood samples were collected for the analysis of HbA1c.

Outcome measures

Outcome measures
Measure	Participants With COPD - GOLD Grade I n=190 Participants Participants with COPD classified using the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Grade I (mild COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade II n=73 Participants Participants with COPD classified using the GOLD Grade II (moderate COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade III n=42 Participants Participants with COPD classified using the GOLD Grade III (severe COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	Participants With COPD - GOLD Grade IV Participants with COPD classified using the GOLD Grade IV (very severe COPD) were enrolled in this cohort. No study treatment was administered during conduct of this non-interventional study.	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.	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.
Sub-cohort: Absolute Values of HbA1c at Month 30	5.74 Percentage of HbA1c in blood Standard Deviation 0.754	5.99 Percentage of HbA1c in blood Standard Deviation 1.227	5.83 Percentage of HbA1c in blood Standard Deviation 0.739	—	—	—

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER