Trial Outcomes & Findings for Chronic Obstructive Pulmonary Disease (COPD) Maintenance Treatment Patterns in China (NCT NCT04853238)

Last Updated: 2024-12-06

Results Overview

Participants who received prescription for COPD maintenance treatment were reported for following categories; Use the maintenance treatment, Long-Acting Muscarinic Antagonist (LAMA), Long-Acting Beta-Agonist (LABA), LABA/LAMA, inhaled corticosteroid (ICS)/LABA, Triple therapy (ICS/LABA/LAMA, Single Inhaler Triple Therapy \[SITT\]), Multiple Inhaler Triple Therapy (MITT), Theophylline, MITT or SITT, N-acetyl cysteine/carbocysteine. The measurement at Baseline visit (Day 1) was defined as Baseline. Participants may have received more than one COPD maintenance treatment. Hence, they may have counted in more than one category, so the total may not match to Number analyzed (N).

Recruitment status

COMPLETED

Target enrollment

1507 participants

Primary outcome timeframe

At Baseline (Day 1)

Results posted on

2024-12-06

Participant Flow

This non-interventional study aims to assess Chronic Obstructive Pulmonary Disease (COPD) maintenance treatment patterns among newly diagnosed and previously diagnosed participants with COPD presenting to clinics, either in a stable state or with acute exacerbation. No study treatment was administered in current study (NCT04853238).

A total of 1507 participants were enrolled in the study (Enrolled Population: All participants who passed screening \[met eligibility criteria\] and entered the study).

Participant milestones

Participant milestones
Measure	Cohort 1: Participants Presenting With Stable Disease Participants with newly diagnosed and previously diagnosed COPD presenting to clinics in a stable state (no exacerbation for at least 1 month) were included in this cohort.	Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization Participants with newly diagnosed and previously diagnosed COPD with moderate acute exacerbations not requiring hospitalization were included in this cohort.	Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation Participants with newly diagnosed and previously diagnosed COPD with acute exacerbation requiring hospitalization were included in this cohort.
Overall Study STARTED	802	71	634
Overall Study Analysis Data Set	797	71	615
Overall Study COMPLETED	772	68	561
Overall Study NOT COMPLETED	30	3	73

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1: Participants Presenting With Stable Disease Participants with newly diagnosed and previously diagnosed COPD presenting to clinics in a stable state (no exacerbation for at least 1 month) were included in this cohort.	Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization Participants with newly diagnosed and previously diagnosed COPD with moderate acute exacerbations not requiring hospitalization were included in this cohort.	Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation Participants with newly diagnosed and previously diagnosed COPD with acute exacerbation requiring hospitalization were included in this cohort.
Overall Study Death	4	0	2
Overall Study Lost to Follow-up	16	2	37
Overall Study Poor adherence, unable to cooperate with investigator to complete test	1	1	10
Overall Study Withdrawal by Subject	6	0	21
Overall Study Physician Decision	0	0	2
Overall Study Violation of inclusion/exclusion criteria	3	0	1

Baseline Characteristics

Chronic Obstructive Pulmonary Disease (COPD) Maintenance Treatment Patterns in China

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1: Participants Presenting With Stable Disease n=797 Participants Participants with newly diagnosed and previously diagnosed COPD presenting to clinics in a stable state (no exacerbation for at least 1 month) were included in this cohort.	Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization n=71 Participants Participants with newly diagnosed and previously diagnosed COPD with moderate acute exacerbations not requiring hospitalization were included in this cohort.	Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation n=615 Participants Participants with newly diagnosed and previously diagnosed COPD with acute exacerbation requiring hospitalization were included in this cohort.	Total n=1483 Participants Total of all reporting groups
Age, Continuous	67.1 Years STANDARD_DEVIATION 8.15 • n=5 Participants	68.3 Years STANDARD_DEVIATION 8.40 • n=7 Participants	69.1 Years STANDARD_DEVIATION 8.28 • n=5 Participants	68.0 Years STANDARD_DEVIATION 8.27 • n=4 Participants
Sex: Female, Male Female	94 Participants n=5 Participants	5 Participants n=7 Participants	69 Participants n=5 Participants	168 Participants n=4 Participants
Sex: Female, Male Male	703 Participants n=5 Participants	66 Participants n=7 Participants	546 Participants n=5 Participants	1315 Participants n=4 Participants
Race/Ethnicity, Customized Asian-Chinese	797 Participants n=5 Participants	71 Participants n=7 Participants	615 Participants n=5 Participants	1483 Participants n=4 Participants

PRIMARY outcome

Timeframe: At Baseline (Day 1)

Population: Analysis data set which included all participants from enrolled population excluding those who did not enter the study as they did not meet Protocol-defined eligibility criteria. 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.

Outcome measures

Outcome measures
Measure	Cohort 1: Participants Presenting With Stable Disease n=797 Participants Participants with newly diagnosed and previously diagnosed COPD presenting to clinics in a stable state (no exacerbation for at least 1 month) were included in this cohort.	Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization n=71 Participants Participants with newly diagnosed and previously diagnosed COPD with moderate acute exacerbations not requiring hospitalization were included in this cohort.	Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation n=615 Participants Participants with newly diagnosed and previously diagnosed COPD with acute exacerbation requiring hospitalization were included in this cohort.
Number of Participants Who Received COPD Prescription for Maintenance Treatment at Baseline Use the maintenance treatment	735 Participants	68 Participants	554 Participants
Number of Participants Who Received COPD Prescription for Maintenance Treatment at Baseline LAMA	105 Participants	3 Participants	13 Participants
Number of Participants Who Received COPD Prescription for Maintenance Treatment at Baseline LABA	1 Participants	0 Participants	0 Participants
Number of Participants Who Received COPD Prescription for Maintenance Treatment at Baseline LABA/LAMA	164 Participants	16 Participants	34 Participants
Number of Participants Who Received COPD Prescription for Maintenance Treatment at Baseline ICS/LABA	165 Participants	20 Participants	107 Participants
Number of Participants Who Received COPD Prescription for Maintenance Treatment at Baseline Triple therapy (ICS/LABA/LAMA, SITT)	225 Participants	17 Participants	126 Participants
Number of Participants Who Received COPD Prescription for Maintenance Treatment at Baseline MITT	55 Participants	6 Participants	43 Participants
Number of Participants Who Received COPD Prescription for Maintenance Treatment at Baseline Theophylline	117 Participants	12 Participants	427 Participants
Number of Participants Who Received COPD Prescription for Maintenance Treatment at Baseline MITT or SITT	280 Participants	23 Participants	169 Participants
Number of Participants Who Received COPD Prescription for Maintenance Treatment at Baseline N-acetyl cysteine/carbocysteine	81 Participants	16 Participants	240 Participants

PRIMARY outcome

Timeframe: At 3 months

Participants who received prescription for COPD maintenance treatment were reported for following categories; Use the maintenance treatment, LAMA, LABA, LABA/LAMA, ICS/LABA, Triple therapy (ICS/LABA/LAMA, SITT), MITT, Theophylline, MITT or SITT, N-acetyl cysteine/carbocysteine. Participants may have received more than one COPD maintenance treatment. Hence, they may have counted in more than one category, so the total may not match to Number analyzed (N).

Outcome measures

Outcome measures
Measure	Cohort 1: Participants Presenting With Stable Disease n=797 Participants Participants with newly diagnosed and previously diagnosed COPD presenting to clinics in a stable state (no exacerbation for at least 1 month) were included in this cohort.	Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization n=71 Participants Participants with newly diagnosed and previously diagnosed COPD with moderate acute exacerbations not requiring hospitalization were included in this cohort.	Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation n=615 Participants Participants with newly diagnosed and previously diagnosed COPD with acute exacerbation requiring hospitalization were included in this cohort.
Number of Participants Who Received COPD Prescription for Maintenance Treatment at 3 Months Use the maintenance treatment	685 Participants	57 Participants	433 Participants
Number of Participants Who Received COPD Prescription for Maintenance Treatment at 3 Months LAMA	95 Participants	6 Participants	26 Participants
Number of Participants Who Received COPD Prescription for Maintenance Treatment at 3 Months LABA	1 Participants	0 Participants	0 Participants
Number of Participants Who Received COPD Prescription for Maintenance Treatment at 3 Months LABA/LAMA	138 Participants	12 Participants	36 Participants
Number of Participants Who Received COPD Prescription for Maintenance Treatment at 3 Months ICS/LABA	143 Participants	20 Participants	115 Participants
Number of Participants Who Received COPD Prescription for Maintenance Treatment at 3 Months Triple therapy (ICS/LABA/LAMA, SITT)	241 Participants	13 Participants	186 Participants
Number of Participants Who Received COPD Prescription for Maintenance Treatment at 3 Months MITT	46 Participants	3 Participants	41 Participants
Number of Participants Who Received COPD Prescription for Maintenance Treatment at 3 Months Theophylline	91 Participants	7 Participants	80 Participants
Number of Participants Who Received COPD Prescription for Maintenance Treatment at 3 Months MITT or SITT	287 Participants	16 Participants	227 Participants
Number of Participants Who Received COPD Prescription for Maintenance Treatment at 3 Months N-acetyl cysteine/carbocysteine	69 Participants	9 Participants	57 Participants

PRIMARY outcome

Timeframe: At Week 1

Participants with moderate acute exacerbation requiring no hospitalization, who received prescription for COPD maintenance treatment were reported for following categories; Use the maintenance treatment, LAMA, LABA, LABA/LAMA, ICS/LABA, Triple therapy (ICS/LABA/LAMA, SITT), MITT, Theophylline, MITT or SITT, N-acetyl cysteine/carbocysteine. Participants may have received more than one COPD maintenance treatment. Hence, they may have counted in more than one category, so the total may not match to Number analyzed (N).

Outcome measures

Outcome measures
Measure	Cohort 1: Participants Presenting With Stable Disease n=71 Participants Participants with newly diagnosed and previously diagnosed COPD presenting to clinics in a stable state (no exacerbation for at least 1 month) were included in this cohort.	Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization Participants with newly diagnosed and previously diagnosed COPD with moderate acute exacerbations not requiring hospitalization were included in this cohort.	Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation Participants with newly diagnosed and previously diagnosed COPD with acute exacerbation requiring hospitalization were included in this cohort.
Number of Participants With Moderate Acute Exacerbation Requiring no Hospitalization by Each COPD Maintenance Treatment at Follow-up (Week 1) Use the maintenance treatment	17 Participants	—	—
Number of Participants With Moderate Acute Exacerbation Requiring no Hospitalization by Each COPD Maintenance Treatment at Follow-up (Week 1) LAMA	3 Participants	—	—
Number of Participants With Moderate Acute Exacerbation Requiring no Hospitalization by Each COPD Maintenance Treatment at Follow-up (Week 1) LABA	0 Participants	—	—
Number of Participants With Moderate Acute Exacerbation Requiring no Hospitalization by Each COPD Maintenance Treatment at Follow-up (Week 1) LABA/LAMA	1 Participants	—	—
Number of Participants With Moderate Acute Exacerbation Requiring no Hospitalization by Each COPD Maintenance Treatment at Follow-up (Week 1) ICS/LABA	3 Participants	—	—
Number of Participants With Moderate Acute Exacerbation Requiring no Hospitalization by Each COPD Maintenance Treatment at Follow-up (Week 1) Triple therapy (ICS/LABA/LAMA, SITT)	2 Participants	—	—
Number of Participants With Moderate Acute Exacerbation Requiring no Hospitalization by Each COPD Maintenance Treatment at Follow-up (Week 1) MITT	0 Participants	—	—
Number of Participants With Moderate Acute Exacerbation Requiring no Hospitalization by Each COPD Maintenance Treatment at Follow-up (Week 1) Theophylline	5 Participants	—	—
Number of Participants With Moderate Acute Exacerbation Requiring no Hospitalization by Each COPD Maintenance Treatment at Follow-up (Week 1) MITT or SITT	2 Participants	—	—
Number of Participants With Moderate Acute Exacerbation Requiring no Hospitalization by Each COPD Maintenance Treatment at Follow-up (Week 1) N-acetyl cysteine/carbocysteine	6 Participants	—	—

PRIMARY outcome

Timeframe: At Discharge follow-up (up to 28 days)

Participants with acute exacerbation requiring hospitalization who received prescription for COPD maintenance treatment were reported for following categories; Use the maintenance treatment. LAMA, LABA, LABA/LAMA, ICS/LABA, Triple therapy (ICS/LABA/LAMA, SITT), MITT, Theophylline, MITT or SITT, N-acetyl cysteine/carbocysteine. Participants may have received more than one COPD maintenance treatment. Hence, they may have counted in more than one category, so the total may not match to Number analyzed (N).

Outcome measures

Outcome measures
Measure	Cohort 1: Participants Presenting With Stable Disease n=615 Participants Participants with newly diagnosed and previously diagnosed COPD presenting to clinics in a stable state (no exacerbation for at least 1 month) were included in this cohort.	Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization Participants with newly diagnosed and previously diagnosed COPD with moderate acute exacerbations not requiring hospitalization were included in this cohort.	Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation Participants with newly diagnosed and previously diagnosed COPD with acute exacerbation requiring hospitalization were included in this cohort.
Number of Participants With Acute Exacerbation Requiring Hospitalization by Each COPD Maintenance Treatment at Discharge Follow-up (up to 28 Days) Use the maintenance treatment	537 Participants	—	—
Number of Participants With Acute Exacerbation Requiring Hospitalization by Each COPD Maintenance Treatment at Discharge Follow-up (up to 28 Days) LAMA	29 Participants	—	—
Number of Participants With Acute Exacerbation Requiring Hospitalization by Each COPD Maintenance Treatment at Discharge Follow-up (up to 28 Days) LABA	0 Participants	—	—
Number of Participants With Acute Exacerbation Requiring Hospitalization by Each COPD Maintenance Treatment at Discharge Follow-up (up to 28 Days) LABA/LAMA	63 Participants	—	—
Number of Participants With Acute Exacerbation Requiring Hospitalization by Each COPD Maintenance Treatment at Discharge Follow-up (up to 28 Days) ICS/LABA	131 Participants	—	—
Number of Participants With Acute Exacerbation Requiring Hospitalization by Each COPD Maintenance Treatment at Discharge Follow-up (up to 28 Days) Triple therapy (ICS/LABA/LAMA, SITT)	196 Participants	—	—
Number of Participants With Acute Exacerbation Requiring Hospitalization by Each COPD Maintenance Treatment at Discharge Follow-up (up to 28 Days) MITT	51 Participants	—	—
Number of Participants With Acute Exacerbation Requiring Hospitalization by Each COPD Maintenance Treatment at Discharge Follow-up (up to 28 Days) Theophylline	164 Participants	—	—
Number of Participants With Acute Exacerbation Requiring Hospitalization by Each COPD Maintenance Treatment at Discharge Follow-up (up to 28 Days) MITT or SITT	247 Participants	—	—
Number of Participants With Acute Exacerbation Requiring Hospitalization by Each COPD Maintenance Treatment at Discharge Follow-up (up to 28 Days) N-acetyl cysteine/carbocysteine	157 Participants	—	—

SECONDARY outcome

Timeframe: At Baseline (Day 1)

FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one minute. FEV1 measurements were collected using a spirometer. The measurement at Baseline visit (Day 1) was defined as Baseline.

Outcome measures

Outcome measures
Measure	Cohort 1: Participants Presenting With Stable Disease n=797 Participants Participants with newly diagnosed and previously diagnosed COPD presenting to clinics in a stable state (no exacerbation for at least 1 month) were included in this cohort.	Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization n=71 Participants Participants with newly diagnosed and previously diagnosed COPD with moderate acute exacerbations not requiring hospitalization were included in this cohort.	Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation n=600 Participants Participants with newly diagnosed and previously diagnosed COPD with acute exacerbation requiring hospitalization were included in this cohort.
Mean Forced Expiratory Volume in One Minute (FEV1) at Baseline	1.424 Liters Standard Deviation 0.6313	1.405 Liters Standard Deviation 0.6178	1.137 Liters Standard Deviation 0.5312

SECONDARY outcome

Timeframe: Within 1 year prior to Baseline (Day 1) visit

Population: Analysis data set which included all participants from enrolled population excluding those who did not enter the study as they did not meet Protocol-defined eligibility criteria. All 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.

Number of participants with history of exacerbations were reported according to the usage of different patterns of maintenance therapy including LAMA, LABA, LABA/LAMA, ICS/LABA, Triple therapy (ICS/LABA/LAMA, SITT), MITT, Theophylline, MITT or SITT, N-acetyl cysteine/carbocysteine. The measurement at Baseline visit (Day 1) was defined as Baseline. Participants may have received more than one COPD maintenance treatment. Hence, they may have counted in more than one category, so the total may not match to Number analyzed (N).

Outcome measures

Outcome measures
Measure	Cohort 1: Participants Presenting With Stable Disease n=797 Participants Participants with newly diagnosed and previously diagnosed COPD presenting to clinics in a stable state (no exacerbation for at least 1 month) were included in this cohort.	Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization n=71 Participants Participants with newly diagnosed and previously diagnosed COPD with moderate acute exacerbations not requiring hospitalization were included in this cohort.	Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation n=615 Participants Participants with newly diagnosed and previously diagnosed COPD with acute exacerbation requiring hospitalization were included in this cohort.
Number of Participants With History of Exacerbations in Within 1 Year Prior to Baseline LAMA	13 Participants	—	15 Participants
Number of Participants With History of Exacerbations in Within 1 Year Prior to Baseline LABA	0 Participants	—	—
Number of Participants With History of Exacerbations in Within 1 Year Prior to Baseline LABA/LAMA	36 Participants	11 Participants	26 Participants
Number of Participants With History of Exacerbations in Within 1 Year Prior to Baseline ICS/LABA	46 Participants	12 Participants	92 Participants
Number of Participants With History of Exacerbations in Within 1 Year Prior to Baseline Triple therapy (ICS/LABA/LAMA, SITT)	52 Participants	7 Participants	97 Participants
Number of Participants With History of Exacerbations in Within 1 Year Prior to Baseline MITT	22 Participants	4 Participants	50 Participants
Number of Participants With History of Exacerbations in Within 1 Year Prior to Baseline Theophylline	45 Participants	7 Participants	326 Participants
Number of Participants With History of Exacerbations in Within 1 Year Prior to Baseline MITT or SITT	74 Participants	11 Participants	147 Participants
Number of Participants With History of Exacerbations in Within 1 Year Prior to Baseline N-acetyl cysteine/carbocysteine	27 Participants	6 Participants	174 Participants

SECONDARY outcome

Timeframe: At Pre-Baseline (Within 1 month before Baseline [Day 1] visit)

Number of participants with COPD medication history were reported for following categories; Use the maintenance treatment, LAMA, LABA, LABA/LAMA, ICS/LABA, Triple therapy (ICS/LABA/LAMA, SITT), MITT, Theophylline, MITT or SITT, N-acetyl cysteine/carbocysteine. The measurement at Baseline visit (Day 1) was defined as Baseline. Participants may have received more than one COPD maintenance treatment. Hence, they may have counted in more than one category, so the total may not match to Number analyzed (N).

Outcome measures

Outcome measures
Measure	Cohort 1: Participants Presenting With Stable Disease n=797 Participants Participants with newly diagnosed and previously diagnosed COPD presenting to clinics in a stable state (no exacerbation for at least 1 month) were included in this cohort.	Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization n=71 Participants Participants with newly diagnosed and previously diagnosed COPD with moderate acute exacerbations not requiring hospitalization were included in this cohort.	Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation n=615 Participants Participants with newly diagnosed and previously diagnosed COPD with acute exacerbation requiring hospitalization were included in this cohort.
Number of Participants With COPD Medication History Use the maintenance treatment	523 Participants	38 Participants	476 Participants
Number of Participants With COPD Medication History LAMA	75 Participants	0 Participants	15 Participants
Number of Participants With COPD Medication History LABA	1 Participants	0 Participants	0 Participants
Number of Participants With COPD Medication History LABA/LAMA	108 Participants	11 Participants	26 Participants
Number of Participants With COPD Medication History ICS/LABA	136 Participants	12 Participants	92 Participants
Number of Participants With COPD Medication History Triple therapy (ICS/LABA/LAMA, SITT)	134 Participants	7 Participants	98 Participants
Number of Participants With COPD Medication History MITT	49 Participants	4 Participants	50 Participants
Number of Participants With COPD Medication History Theophylline	105 Participants	7 Participants	330 Participants
Number of Participants With COPD Medication History MITT or SITT	183 Participants	11 Participants	148 Participants
Number of Participants With COPD Medication History N-acetyl cysteine/carbocysteine	73 Participants	6 Participants	175 Participants

SECONDARY outcome

Timeframe: At 3 months

Population: Analysis data set which included all participants from enrolled population excluding those who did not enter the study as they did not meet Protocol-defined eligibility criteria. All 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.

The CAT is an 8-item unidimensional measure of health status impairment in participants with COPD. Participants are scored on eight items (cough, phlegm, chest tightness, breathlessness, activity limitation, confidence, sleep and energy) on a scale of 0 (no impact) to 5 (worst possible impact) depending on their impact. The sum of scores for each item gives the participant's impact score ranging from 0 (no impact) to 40 (worst possible impact). Higher score indicates worst possible impact. CAT score by historic treatments including LAMA, LABA, LABA/LAMA, ICS/LABA, Triple therapy (ICS/LABA/LAMA, SITT), MITT, Theophylline, MITT or SITT, N-acetyl cysteine/carbocysteine were reported. Participants may have received more than one COPD maintenance treatment. Hence, they may have counted in more than one category, so the total may not match to Number analyzed (N). Mean and standard deviation (SD) values of CAT score assessments at 3 months are reported.

Outcome measures

Outcome measures
Measure	Cohort 1: Participants Presenting With Stable Disease n=797 Participants Participants with newly diagnosed and previously diagnosed COPD presenting to clinics in a stable state (no exacerbation for at least 1 month) were included in this cohort.	Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization n=71 Participants Participants with newly diagnosed and previously diagnosed COPD with moderate acute exacerbations not requiring hospitalization were included in this cohort.	Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation n=615 Participants Participants with newly diagnosed and previously diagnosed COPD with acute exacerbation requiring hospitalization were included in this cohort.
Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) Scores by Historic Treatments at Indicated Time Point LAMA	12.4 Scores on a scale Standard Deviation 8.27	—	19.5 Scores on a scale Standard Deviation 6.73
Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) Scores by Historic Treatments at Indicated Time Point LABA	27.0 Scores on a scale Standard Deviation NA NA indicates standard deviation could not be calculated for a single participant.	—	—
Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) Scores by Historic Treatments at Indicated Time Point LABA/LAMA	13.1 Scores on a scale Standard Deviation 9.03	16.8 Scores on a scale Standard Deviation 8.06	18.7 Scores on a scale Standard Deviation 6.54
Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) Scores by Historic Treatments at Indicated Time Point ICS/LABA	14.8 Scores on a scale Standard Deviation 8.78	14.3 Scores on a scale Standard Deviation 5.07	18.0 Scores on a scale Standard Deviation 8.43
Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) Scores by Historic Treatments at Indicated Time Point Triple therapy (ICS/LABA/LAMA, SITT)	13.7 Scores on a scale Standard Deviation 7.96	14.4 Scores on a scale Standard Deviation 8.04	21.5 Scores on a scale Standard Deviation 8.12
Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) Scores by Historic Treatments at Indicated Time Point MITT	13.7 Scores on a scale Standard Deviation 9.15	15.8 Scores on a scale Standard Deviation 6.02	20.6 Scores on a scale Standard Deviation 7.49
Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) Scores by Historic Treatments at Indicated Time Point Theophylline	14.1 Scores on a scale Standard Deviation 9.04	11.6 Scores on a scale Standard Deviation 6.32	19.4 Scores on a scale Standard Deviation 8.30
Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) Scores by Historic Treatments at Indicated Time Point MITT or SITT	13.7 Scores on a scale Standard Deviation 8.27	14.9 Scores on a scale Standard Deviation 7.08	21.2 Scores on a scale Standard Deviation 7.90
Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) Scores by Historic Treatments at Indicated Time Point N-acetyl cysteine/carbocysteine	13.1 Scores on a scale Standard Deviation 8.68	14.3 Scores on a scale Standard Deviation 9.54	19.3 Scores on a scale Standard Deviation 8.60

SECONDARY outcome

Timeframe: At 3 months

Population: Analysis data set which included all participants from enrolled population excluding those who did not enter the study as they did not meet Protocol-defined eligibility criteria. All 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.

The mMRC questionnaire predicts future mortality risk with mMRC. Participants are required to rate their disability due to shortness of breath on the 5-point mMRC scale ranging from 0 (no impact) to 4 (worst possible impact). Higher score indicates worst possible impact. The mMRC score by historic treatments including LAMA, LABA, LABA/LAMA, ICS/LABA, Triple therapy (ICS/LABA/LAMA, SITT), MITT, Theophylline, MITT or SITT, N-acetyl cysteine/carbocysteine were reported. Participants may have received more than one COPD maintenance treatment. Hence, they may have counted in more than one category, so the total may not match to Number analyzed (N). Mean and SD values of mMRC score assessments at 3 months are reported.

Outcome measures

Outcome measures
Measure	Cohort 1: Participants Presenting With Stable Disease n=797 Participants Participants with newly diagnosed and previously diagnosed COPD presenting to clinics in a stable state (no exacerbation for at least 1 month) were included in this cohort.	Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization n=71 Participants Participants with newly diagnosed and previously diagnosed COPD with moderate acute exacerbations not requiring hospitalization were included in this cohort.	Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation n=615 Participants Participants with newly diagnosed and previously diagnosed COPD with acute exacerbation requiring hospitalization were included in this cohort.
Modified Medical Research Council (mMRC) Score by Historic Treatments at Indicated Time Point LAMA	1.2 Scores on a scale Standard Deviation 0.91	—	2.1 Scores on a scale Standard Deviation 0.92
Modified Medical Research Council (mMRC) Score by Historic Treatments at Indicated Time Point LABA	2.0 Scores on a scale Standard Deviation NA NA indicates standard deviation could not be calculated for a single participant.	—	—
Modified Medical Research Council (mMRC) Score by Historic Treatments at Indicated Time Point LABA/LAMA	1.4 Scores on a scale Standard Deviation 1.02	1.8 Scores on a scale Standard Deviation 0.98	2.0 Scores on a scale Standard Deviation 1.17
Modified Medical Research Council (mMRC) Score by Historic Treatments at Indicated Time Point ICS/LABA	1.7 Scores on a scale Standard Deviation 0.97	1.2 Scores on a scale Standard Deviation 1.19	2.1 Scores on a scale Standard Deviation 1.08
Modified Medical Research Council (mMRC) Score by Historic Treatments at Indicated Time Point Triple therapy (ICS/LABA/LAMA, SITT)	1.7 Scores on a scale Standard Deviation 1.02	1.9 Scores on a scale Standard Deviation 0.69	2.4 Scores on a scale Standard Deviation 1.03
Modified Medical Research Council (mMRC) Score by Historic Treatments at Indicated Time Point MITT	1.8 Scores on a scale Standard Deviation 1.03	2.3 Scores on a scale Standard Deviation 0.96	2.4 Scores on a scale Standard Deviation 1.09
Modified Medical Research Council (mMRC) Score by Historic Treatments at Indicated Time Point Theophylline	1.7 Scores on a scale Standard Deviation 0.99	1.7 Scores on a scale Standard Deviation 0.95	2.2 Scores on a scale Standard Deviation 1.08
Modified Medical Research Council (mMRC) Score by Historic Treatments at Indicated Time Point MITT or SITT	1.7 Scores on a scale Standard Deviation 1.03	2.0 Scores on a scale Standard Deviation 0.77	2.4 Scores on a scale Standard Deviation 1.04
Modified Medical Research Council (mMRC) Score by Historic Treatments at Indicated Time Point N-acetyl cysteine/carbocysteine	1.7 Scores on a scale Standard Deviation 0.99	2.3 Scores on a scale Standard Deviation 1.03	1.9 Scores on a scale Standard Deviation 1.14

SECONDARY outcome

Timeframe: Baseline (Day 1)

DECAF is a 7-point scale with a minimum score of 0 (better outcome) and a maximum score of 6 (worse outcome). Higher score indicates worst outcome. It is used for assessment of severity of COPD exacerbation measures Dyspnea, Eosinopenia, consolidation, acidemia and atrial fibrillation. Number of participants requiring hospitalization by their each DECAF risk groups Mild (0-1 score), moderate (2 score), severe (3-6 score) were summarized. Participants who did not provide scores were categorized under "Missing". The measurement at Baseline visit (Day 1) was defined as Baseline.

Outcome measures

Outcome measures
Measure	Cohort 1: Participants Presenting With Stable Disease n=615 Participants Participants with newly diagnosed and previously diagnosed COPD presenting to clinics in a stable state (no exacerbation for at least 1 month) were included in this cohort.	Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization Participants with newly diagnosed and previously diagnosed COPD with moderate acute exacerbations not requiring hospitalization were included in this cohort.	Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation Participants with newly diagnosed and previously diagnosed COPD with acute exacerbation requiring hospitalization were included in this cohort.
Number of Participants Requiring Hospitalization by Their Each Dyspnea, Eosinopenia, Consolidation, Acidemia and Atrial Fibrillation (DECAF) Risk Group Mild	503 Participants	—	—
Number of Participants Requiring Hospitalization by Their Each Dyspnea, Eosinopenia, Consolidation, Acidemia and Atrial Fibrillation (DECAF) Risk Group Moderate	49 Participants	—	—
Number of Participants Requiring Hospitalization by Their Each Dyspnea, Eosinopenia, Consolidation, Acidemia and Atrial Fibrillation (DECAF) Risk Group Severe	5 Participants	—	—
Number of Participants Requiring Hospitalization by Their Each Dyspnea, Eosinopenia, Consolidation, Acidemia and Atrial Fibrillation (DECAF) Risk Group Missing	58 Participants	—	—

SECONDARY outcome

Timeframe: Up to 3 months

Number of participants with at least one co-morbidity were reported. Co-morbidities included Vascular disorders, Cardiac disorders, Respiratory, thoracic and mediastinal disorders, Metabolism and nutrition disorders, Infections and infestations, Gastrointestinal disorders, Reproductive system and breast disorders, Hepatobiliary disorders, Nervous system disorders, Renal and urinary disorders, Musculoskeletal and connective tissue disorders, Injury, poisoning and procedural complications, Psychiatric disorders, Endocrine disorders, Blood and lymphatic system disorders, Neoplasms benign, malignant and unspecified (including cysts and polyps), Skin and subcutaneous tissue disorders, Eye disorders, Investigations, General disorders and administration site conditions, Ear and labyrinth disorders, Congenital, familial and genetic disorders, Immune system disorders and Surgical and medical procedures).

Outcome measures

Outcome measures
Measure	Cohort 1: Participants Presenting With Stable Disease n=797 Participants Participants with newly diagnosed and previously diagnosed COPD presenting to clinics in a stable state (no exacerbation for at least 1 month) were included in this cohort.	Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization n=71 Participants Participants with newly diagnosed and previously diagnosed COPD with moderate acute exacerbations not requiring hospitalization were included in this cohort.	Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation n=615 Participants Participants with newly diagnosed and previously diagnosed COPD with acute exacerbation requiring hospitalization were included in this cohort.
Number of Participants With at Least One Co-morbidity	512 Participants	52 Participants	571 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1)

Questions were asked to participants to understand their following socio-economic factors associated with different patterns of COPD maintenance treatment;Education(No formal education, Elementary,Middle,High school-including vocational school, Bachelor's degree and above, Missing), Local permanent resident(No,Yes, Missing), Marriage condition(Married,Divorced/Separated,Widowed,Unmarried and Missing), With whom usually live(Live alone, With spouse, With one specific child, Take turns in different children's homes, Other relatives, Missing), National basic medical insurance (Insu.)(None,Government medical insu.,Urban employee medical insu., Urban resident medical insu., New cooperative medical insu., Urban and rural resident basic medical insu., Serious illness insu., Missing) and Commercial insu.(Yes,No,Missing). Participants may have provided more than one answers to questions. Hence, they may have counted in more than one category, so the total may not match to Number analyzed (N).

Outcome measures

Outcome measures
Measure	Cohort 1: Participants Presenting With Stable Disease n=797 Participants Participants with newly diagnosed and previously diagnosed COPD presenting to clinics in a stable state (no exacerbation for at least 1 month) were included in this cohort.	Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization n=71 Participants Participants with newly diagnosed and previously diagnosed COPD with moderate acute exacerbations not requiring hospitalization were included in this cohort.	Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation n=615 Participants Participants with newly diagnosed and previously diagnosed COPD with acute exacerbation requiring hospitalization were included in this cohort.
Number of Participants by Their Socio-economic Characteristics Marriage condition; Divorced/Separated	19 Participants	2 Participants	14 Participants
Number of Participants by Their Socio-economic Characteristics Marriage condition; Widowed	54 Participants	3 Participants	71 Participants
Number of Participants by Their Socio-economic Characteristics Marriage condition; Unmarried	5 Participants	0 Participants	6 Participants
Number of Participants by Their Socio-economic Characteristics Marriage condition; Missing	2 Participants	0 Participants	8 Participants
Number of Participants by Their Socio-economic Characteristics With whom usually live; Live alone	84 Participants	7 Participants	64 Participants
Number of Participants by Their Socio-economic Characteristics With whom usually live; With spouse	612 Participants	53 Participants	415 Participants
Number of Participants by Their Socio-economic Characteristics With whom usually live; With one specific child	175 Participants	21 Participants	173 Participants
Number of Participants by Their Socio-economic Characteristics With whom usually live; Take turns in different children's homes	5 Participants	0 Participants	9 Participants
Number of Participants by Their Socio-economic Characteristics With whom usually live; Other relatives	7 Participants	0 Participants	0 Participants
Number of Participants by Their Socio-economic Characteristics With whom usually live; Missing	2 Participants	0 Participants	8 Participants
Number of Participants by Their Socio-economic Characteristics National basic medical insurance; None	9 Participants	1 Participants	3 Participants
Number of Participants by Their Socio-economic Characteristics National basic medical insurance; Government medical insurance	13 Participants	2 Participants	14 Participants
Number of Participants by Their Socio-economic Characteristics National basic medical insurance; Urban employee medical insurance	395 Participants	28 Participants	260 Participants
Number of Participants by Their Socio-economic Characteristics National basic medical insurance; Urban resident medical insurance	111 Participants	10 Participants	99 Participants
Number of Participants by Their Socio-economic Characteristics National basic medical insurance; New cooperative medical insurance	176 Participants	11 Participants	195 Participants
Number of Participants by Their Socio-economic Characteristics National basic medical insurance; Urban and rural resident basic medical insurance	89 Participants	19 Participants	31 Participants
Number of Participants by Their Socio-economic Characteristics National basic medical insurance; Serious illness insurance	2 Participants	0 Participants	2 Participants
Number of Participants by Their Socio-economic Characteristics National basic medical insurance; Missing	2 Participants	0 Participants	11 Participants
Number of Participants by Their Socio-economic Characteristics Commercial insurance; No	727 Participants	65 Participants	564 Participants
Number of Participants by Their Socio-economic Characteristics Commercial insurance; Yes	68 Participants	6 Participants	42 Participants
Number of Participants by Their Socio-economic Characteristics Commercial insurance; Missing	2 Participants	0 Participants	9 Participants
Number of Participants by Their Socio-economic Characteristics Education; No formal education	38 Participants	1 Participants	40 Participants
Number of Participants by Their Socio-economic Characteristics Education; Elementary school	219 Participants	27 Participants	187 Participants
Number of Participants by Their Socio-economic Characteristics Education; Middle school	286 Participants	24 Participants	214 Participants
Number of Participants by Their Socio-economic Characteristics Education; High school-including vocational school	167 Participants	15 Participants	118 Participants
Number of Participants by Their Socio-economic Characteristics Education; Bachelor's degree and above	85 Participants	4 Participants	48 Participants
Number of Participants by Their Socio-economic Characteristics Education; Missing	2 Participants	0 Participants	8 Participants
Number of Participants by Their Socio-economic Characteristics Local permanent resident; No	69 Participants	7 Participants	89 Participants
Number of Participants by Their Socio-economic Characteristics Local permanent resident; Yes	726 Participants	64 Participants	518 Participants
Number of Participants by Their Socio-economic Characteristics Local permanent resident; Missing	2 Participants	0 Participants	8 Participants
Number of Participants by Their Socio-economic Characteristics Marriage condition; Married	717 Participants	66 Participants	516 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 1, Discharge follow-up (up to 28 days) and at 3 months

The CAT is an 8-item unidimensional measure of health status impairment in participants with COPD. Participants are scored on eight items (cough, phlegm, chest tightness, breathlessness, activity limitation, confidence, sleep and energy) on a scale of 0 (no impact) to 5 (worst possible impact) depending on their impact. The sum of scores for each item gives the participant's impact score ranging from 0 (no impact) to 40 (worst possible impact). Higher score indicates worst possible impact. Number of participants by their CAT scores were reported (\<=10, 11 to 20, 21 to 30, 31 to 40). Participants who did not provide scores were categorized under "Missing". The measurement at Baseline visit (Day 1) was defined as Baseline.

Outcome measures

Outcome measures
Measure	Cohort 1: Participants Presenting With Stable Disease n=797 Participants Participants with newly diagnosed and previously diagnosed COPD presenting to clinics in a stable state (no exacerbation for at least 1 month) were included in this cohort.	Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization n=71 Participants Participants with newly diagnosed and previously diagnosed COPD with moderate acute exacerbations not requiring hospitalization were included in this cohort.	Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation n=615 Participants Participants with newly diagnosed and previously diagnosed COPD with acute exacerbation requiring hospitalization were included in this cohort.
Number of Participants by Their COPD Assessment Test (CAT) Scores at Indicated Time Points At 3 months; Score 11 to 20	238 Participants	21 Participants	213 Participants
Number of Participants by Their COPD Assessment Test (CAT) Scores at Indicated Time Points Baseline (Day 1); Score <=10	300 Participants	20 Participants	109 Participants
Number of Participants by Their COPD Assessment Test (CAT) Scores at Indicated Time Points Baseline (Day 1); Scores 11 to 20	318 Participants	32 Participants	250 Participants
Number of Participants by Their COPD Assessment Test (CAT) Scores at Indicated Time Points Baseline (Day 1); Scores 21 to 30	148 Participants	18 Participants	199 Participants
Number of Participants by Their COPD Assessment Test (CAT) Scores at Indicated Time Points Baseline (Day 1); Scores 31 to 40	30 Participants	1 Participants	52 Participants
Number of Participants by Their COPD Assessment Test (CAT) Scores at Indicated Time Points Baseline (Day 1); Missing	1 Participants	0 Participants	5 Participants
Number of Participants by Their COPD Assessment Test (CAT) Scores at Indicated Time Points Week 1; Score <=10	—	31 Participants	—
Number of Participants by Their COPD Assessment Test (CAT) Scores at Indicated Time Points Week 1; Scores 11 to 20	—	24 Participants	—
Number of Participants by Their COPD Assessment Test (CAT) Scores at Indicated Time Points Week 1; Scores 21 to 30	—	12 Participants	—
Number of Participants by Their COPD Assessment Test (CAT) Scores at Indicated Time Points Week 1; Scores 31 to 40	—	1 Participants	—
Number of Participants by Their COPD Assessment Test (CAT) Scores at Indicated Time Points Week 1; Missing	—	3 Participants	—
Number of Participants by Their COPD Assessment Test (CAT) Scores at Indicated Time Points Discharge follow-up (up to 28 days); Score <=10	—	—	229 Participants
Number of Participants by Their COPD Assessment Test (CAT) Scores at Indicated Time Points Discharge follow-up (up to 28 days); Scores 11 to 20	—	—	246 Participants
Number of Participants by Their COPD Assessment Test (CAT) Scores at Indicated Time Points Discharge follow-up (up to 28 days); Scores 21 to 30	—	—	95 Participants
Number of Participants by Their COPD Assessment Test (CAT) Scores at Indicated Time Points Discharge follow-up (up to 28 days); Scores 31 to 40	—	—	19 Participants
Number of Participants by Their COPD Assessment Test (CAT) Scores at Indicated Time Points Discharge follow-up (up to 28 days); Missing	—	—	26 Participants
Number of Participants by Their COPD Assessment Test (CAT) Scores at Indicated Time Points At 3 months; Score <=10	420 Participants	38 Participants	239 Participants
Number of Participants by Their COPD Assessment Test (CAT) Scores at Indicated Time Points At 3 months; Score 21 to 30	90 Participants	7 Participants	71 Participants
Number of Participants by Their COPD Assessment Test (CAT) Scores at Indicated Time Points At 3 months; Score 31 to 40	21 Participants	1 Participants	22 Participants
Number of Participants by Their COPD Assessment Test (CAT) Scores at Indicated Time Points At 3 months; Missing	28 Participants	4 Participants	70 Participants

SECONDARY outcome

Timeframe: At Baseline (Day 1)

Outcome measures

Outcome measures
Measure	Cohort 1: Participants Presenting With Stable Disease n=797 Participants Participants with newly diagnosed and previously diagnosed COPD presenting to clinics in a stable state (no exacerbation for at least 1 month) were included in this cohort.	Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization n=71 Participants Participants with newly diagnosed and previously diagnosed COPD with moderate acute exacerbations not requiring hospitalization were included in this cohort.	Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation n=615 Participants Participants with newly diagnosed and previously diagnosed COPD with acute exacerbation requiring hospitalization were included in this cohort.
Number of Participants by Their Modified British Medical Research Council (mMRC) Score at Baseline Score 0	127 Participants	14 Participants	37 Participants
Number of Participants by Their Modified British Medical Research Council (mMRC) Score at Baseline Score 1	279 Participants	17 Participants	130 Participants
Number of Participants by Their Modified British Medical Research Council (mMRC) Score at Baseline Score 2	258 Participants	24 Participants	202 Participants
Number of Participants by Their Modified British Medical Research Council (mMRC) Score at Baseline Score 3	118 Participants	13 Participants	163 Participants
Number of Participants by Their Modified British Medical Research Council (mMRC) Score at Baseline Score 4	14 Participants	3 Participants	78 Participants
Number of Participants by Their Modified British Medical Research Council (mMRC) Score at Baseline Missing	1 Participants	0 Participants	5 Participants

SECONDARY outcome

Timeframe: Up to 3 months

Number of participants whose prescribed maintenance therapy was stepped up (adding another maintenance therapy), stepped down (withdraw any of the maintenance medication but kept the maintenance therapy), stopped (stop all maintenance therapy), switched (between LAMA/LABA and ICS/LABA) or remained the same were reported. Participants whose treatment was not categorized in any of the above, were reported under Missing.

Outcome measures

Outcome measures
Measure	Cohort 1: Participants Presenting With Stable Disease n=797 Participants Participants with newly diagnosed and previously diagnosed COPD presenting to clinics in a stable state (no exacerbation for at least 1 month) were included in this cohort.	Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization n=71 Participants Participants with newly diagnosed and previously diagnosed COPD with moderate acute exacerbations not requiring hospitalization were included in this cohort.	Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation n=615 Participants Participants with newly diagnosed and previously diagnosed COPD with acute exacerbation requiring hospitalization were included in this cohort.
Number of Participants Whose Prescribed Maintenance Treatment Was Stepped up, Stepped Down, Stopped, Switched, Remained the Same Stepped up	67 Participants	4 Participants	180 Participants
Number of Participants Whose Prescribed Maintenance Treatment Was Stepped up, Stepped Down, Stopped, Switched, Remained the Same Stepped down	26 Participants	1 Participants	14 Participants
Number of Participants Whose Prescribed Maintenance Treatment Was Stepped up, Stepped Down, Stopped, Switched, Remained the Same Stopped	25 Participants	1 Participants	18 Participants
Number of Participants Whose Prescribed Maintenance Treatment Was Stepped up, Stepped Down, Stopped, Switched, Remained the Same Switched	9 Participants	1 Participants	0 Participants
Number of Participants Whose Prescribed Maintenance Treatment Was Stepped up, Stepped Down, Stopped, Switched, Remained the Same Remained the same	568 Participants	30 Participants	186 Participants
Number of Participants Whose Prescribed Maintenance Treatment Was Stepped up, Stepped Down, Stopped, Switched, Remained the Same Missing	102 Participants	34 Participants	217 Participants

SECONDARY outcome

Timeframe: At 3 months

Number of participants receiving COPD maintenance treatment including LAMA, LABA/LAMA, ICS/LABA, Triple therapy (ICS/LABA/LAMA, SITT), MITT, Theophylline, MITT or SITT, N-acetyl cysteine/carbocysteine were reported. Participants may have received more than one COPD maintenance treatment. Hence, they may have counted in more than one category, so the total may not match to Number analyzed (N).

Outcome measures

Outcome measures
Measure	Cohort 1: Participants Presenting With Stable Disease n=797 Participants Participants with newly diagnosed and previously diagnosed COPD presenting to clinics in a stable state (no exacerbation for at least 1 month) were included in this cohort.	Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization n=71 Participants Participants with newly diagnosed and previously diagnosed COPD with moderate acute exacerbations not requiring hospitalization were included in this cohort.	Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation n=615 Participants Participants with newly diagnosed and previously diagnosed COPD with acute exacerbation requiring hospitalization were included in this cohort.
Number of Participants Receiving COPD Maintenance Treatment at 3 Months LAMA	92 Participants	6 Participants	20 Participants
Number of Participants Receiving COPD Maintenance Treatment at 3 Months LABA/LAMA	127 Participants	12 Participants	35 Participants
Number of Participants Receiving COPD Maintenance Treatment at 3 Months ICS/LABA	136 Participants	21 Participants	109 Participants
Number of Participants Receiving COPD Maintenance Treatment at 3 Months Triple therapy (ICS/LABA/LAMA, SITT)	240 Participants	11 Participants	181 Participants
Number of Participants Receiving COPD Maintenance Treatment at 3 Months MITT	51 Participants	4 Participants	46 Participants
Number of Participants Receiving COPD Maintenance Treatment at 3 Months Theophylline	93 Participants	6 Participants	82 Participants
Number of Participants Receiving COPD Maintenance Treatment at 3 Months MITT or SITT	291 Participants	15 Participants	227 Participants
Number of Participants Receiving COPD Maintenance Treatment at 3 Months N-acetyl cysteine/carbocysteine	80 Participants	7 Participants	52 Participants

Adverse Events

Cohort 1: Participants Presenting With Stable Disease

Serious events: 5 serious events

Other events: 2 other events

Deaths: 4 deaths

Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation

Serious events: 4 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1: Participants Presenting With Stable Disease n=797 participants at risk Participants with newly diagnosed and previously diagnosed COPD presenting to clinics in a stable state (no exacerbation for at least 1 month) were included in this cohort.	Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization n=71 participants at risk Participants with newly diagnosed and previously diagnosed COPD with moderate acute exacerbations not requiring hospitalization were included in this cohort.	Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation n=615 participants at risk Participants with newly diagnosed and previously diagnosed COPD with acute exacerbation requiring hospitalization were included in this cohort.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.38% 3/797 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 3 months All-cause mortality, SAEs and Non-SAEs were reported for Analysis Data Set (1483) since 24 participants from Enrolled Population (1507) did not enter the study as they did not meet Protocol-defined eligibility criteria. Analysis data set included all participants from enrolled population excluding those who did not enter the study as they did not meet Protocol-defined eligibility criteria.	1.4% 1/71 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 3 months All-cause mortality, SAEs and Non-SAEs were reported for Analysis Data Set (1483) since 24 participants from Enrolled Population (1507) did not enter the study as they did not meet Protocol-defined eligibility criteria. Analysis data set included all participants from enrolled population excluding those who did not enter the study as they did not meet Protocol-defined eligibility criteria.	0.33% 2/615 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 3 months All-cause mortality, SAEs and Non-SAEs were reported for Analysis Data Set (1483) since 24 participants from Enrolled Population (1507) did not enter the study as they did not meet Protocol-defined eligibility criteria. Analysis data set included all participants from enrolled population excluding those who did not enter the study as they did not meet Protocol-defined eligibility criteria.
Cardiac disorders Cardiac arrest	0.13% 1/797 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 3 months All-cause mortality, SAEs and Non-SAEs were reported for Analysis Data Set (1483) since 24 participants from Enrolled Population (1507) did not enter the study as they did not meet Protocol-defined eligibility criteria. Analysis data set included all participants from enrolled population excluding those who did not enter the study as they did not meet Protocol-defined eligibility criteria.	0.00% 0/71 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 3 months All-cause mortality, SAEs and Non-SAEs were reported for Analysis Data Set (1483) since 24 participants from Enrolled Population (1507) did not enter the study as they did not meet Protocol-defined eligibility criteria. Analysis data set included all participants from enrolled population excluding those who did not enter the study as they did not meet Protocol-defined eligibility criteria.	0.00% 0/615 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 3 months All-cause mortality, SAEs and Non-SAEs were reported for Analysis Data Set (1483) since 24 participants from Enrolled Population (1507) did not enter the study as they did not meet Protocol-defined eligibility criteria. Analysis data set included all participants from enrolled population excluding those who did not enter the study as they did not meet Protocol-defined eligibility criteria.
General disorders Death	0.00% 0/797 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 3 months All-cause mortality, SAEs and Non-SAEs were reported for Analysis Data Set (1483) since 24 participants from Enrolled Population (1507) did not enter the study as they did not meet Protocol-defined eligibility criteria. Analysis data set included all participants from enrolled population excluding those who did not enter the study as they did not meet Protocol-defined eligibility criteria.	0.00% 0/71 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 3 months All-cause mortality, SAEs and Non-SAEs were reported for Analysis Data Set (1483) since 24 participants from Enrolled Population (1507) did not enter the study as they did not meet Protocol-defined eligibility criteria. Analysis data set included all participants from enrolled population excluding those who did not enter the study as they did not meet Protocol-defined eligibility criteria.	0.16% 1/615 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 3 months All-cause mortality, SAEs and Non-SAEs were reported for Analysis Data Set (1483) since 24 participants from Enrolled Population (1507) did not enter the study as they did not meet Protocol-defined eligibility criteria. Analysis data set included all participants from enrolled population excluding those who did not enter the study as they did not meet Protocol-defined eligibility criteria.
Gastrointestinal disorders Intestinal perforation	0.00% 0/797 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 3 months All-cause mortality, SAEs and Non-SAEs were reported for Analysis Data Set (1483) since 24 participants from Enrolled Population (1507) did not enter the study as they did not meet Protocol-defined eligibility criteria. Analysis data set included all participants from enrolled population excluding those who did not enter the study as they did not meet Protocol-defined eligibility criteria.	0.00% 0/71 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 3 months All-cause mortality, SAEs and Non-SAEs were reported for Analysis Data Set (1483) since 24 participants from Enrolled Population (1507) did not enter the study as they did not meet Protocol-defined eligibility criteria. Analysis data set included all participants from enrolled population excluding those who did not enter the study as they did not meet Protocol-defined eligibility criteria.	0.16% 1/615 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 3 months All-cause mortality, SAEs and Non-SAEs were reported for Analysis Data Set (1483) since 24 participants from Enrolled Population (1507) did not enter the study as they did not meet Protocol-defined eligibility criteria. Analysis data set included all participants from enrolled population excluding those who did not enter the study as they did not meet Protocol-defined eligibility criteria.
Injury, poisoning and procedural complications Fall	0.13% 1/797 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 3 months All-cause mortality, SAEs and Non-SAEs were reported for Analysis Data Set (1483) since 24 participants from Enrolled Population (1507) did not enter the study as they did not meet Protocol-defined eligibility criteria. Analysis data set included all participants from enrolled population excluding those who did not enter the study as they did not meet Protocol-defined eligibility criteria.	0.00% 0/71 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 3 months All-cause mortality, SAEs and Non-SAEs were reported for Analysis Data Set (1483) since 24 participants from Enrolled Population (1507) did not enter the study as they did not meet Protocol-defined eligibility criteria. Analysis data set included all participants from enrolled population excluding those who did not enter the study as they did not meet Protocol-defined eligibility criteria.	0.00% 0/615 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 3 months All-cause mortality, SAEs and Non-SAEs were reported for Analysis Data Set (1483) since 24 participants from Enrolled Population (1507) did not enter the study as they did not meet Protocol-defined eligibility criteria. Analysis data set included all participants from enrolled population excluding those who did not enter the study as they did not meet Protocol-defined eligibility criteria.

Other adverse events

Other adverse events
Measure	Cohort 1: Participants Presenting With Stable Disease n=797 participants at risk Participants with newly diagnosed and previously diagnosed COPD presenting to clinics in a stable state (no exacerbation for at least 1 month) were included in this cohort.	Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization n=71 participants at risk Participants with newly diagnosed and previously diagnosed COPD with moderate acute exacerbations not requiring hospitalization were included in this cohort.	Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation n=615 participants at risk Participants with newly diagnosed and previously diagnosed COPD with acute exacerbation requiring hospitalization were included in this cohort.
Eye disorders Cataract	0.13% 1/797 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 3 months All-cause mortality, SAEs and Non-SAEs were reported for Analysis Data Set (1483) since 24 participants from Enrolled Population (1507) did not enter the study as they did not meet Protocol-defined eligibility criteria. Analysis data set included all participants from enrolled population excluding those who did not enter the study as they did not meet Protocol-defined eligibility criteria.	0.00% 0/71 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 3 months All-cause mortality, SAEs and Non-SAEs were reported for Analysis Data Set (1483) since 24 participants from Enrolled Population (1507) did not enter the study as they did not meet Protocol-defined eligibility criteria. Analysis data set included all participants from enrolled population excluding those who did not enter the study as they did not meet Protocol-defined eligibility criteria.	0.00% 0/615 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 3 months All-cause mortality, SAEs and Non-SAEs were reported for Analysis Data Set (1483) since 24 participants from Enrolled Population (1507) did not enter the study as they did not meet Protocol-defined eligibility criteria. Analysis data set included all participants from enrolled population excluding those who did not enter the study as they did not meet Protocol-defined eligibility criteria.
Infections and infestations Conjunctivitis	0.13% 1/797 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 3 months All-cause mortality, SAEs and Non-SAEs were reported for Analysis Data Set (1483) since 24 participants from Enrolled Population (1507) did not enter the study as they did not meet Protocol-defined eligibility criteria. Analysis data set included all participants from enrolled population excluding those who did not enter the study as they did not meet Protocol-defined eligibility criteria.	0.00% 0/71 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 3 months All-cause mortality, SAEs and Non-SAEs were reported for Analysis Data Set (1483) since 24 participants from Enrolled Population (1507) did not enter the study as they did not meet Protocol-defined eligibility criteria. Analysis data set included all participants from enrolled population excluding those who did not enter the study as they did not meet Protocol-defined eligibility criteria.	0.00% 0/615 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 3 months All-cause mortality, SAEs and Non-SAEs were reported for Analysis Data Set (1483) since 24 participants from Enrolled Population (1507) did not enter the study as they did not meet Protocol-defined eligibility criteria. Analysis data set included all participants from enrolled population excluding those who did not enter the study as they did not meet Protocol-defined eligibility criteria.
Renal and urinary disorders Urinary retention	0.13% 1/797 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 3 months All-cause mortality, SAEs and Non-SAEs were reported for Analysis Data Set (1483) since 24 participants from Enrolled Population (1507) did not enter the study as they did not meet Protocol-defined eligibility criteria. Analysis data set included all participants from enrolled population excluding those who did not enter the study as they did not meet Protocol-defined eligibility criteria.	0.00% 0/71 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 3 months All-cause mortality, SAEs and Non-SAEs were reported for Analysis Data Set (1483) since 24 participants from Enrolled Population (1507) did not enter the study as they did not meet Protocol-defined eligibility criteria. Analysis data set included all participants from enrolled population excluding those who did not enter the study as they did not meet Protocol-defined eligibility criteria.	0.00% 0/615 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 3 months All-cause mortality, SAEs and Non-SAEs were reported for Analysis Data Set (1483) since 24 participants from Enrolled Population (1507) did not enter the study as they did not meet Protocol-defined eligibility criteria. Analysis data set included all participants from enrolled population excluding those who did not enter the study as they did not meet Protocol-defined eligibility criteria.

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