Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
Chronic obstructive pulmonary disease, China, Disease burden, Maintenance treatment patterns
Brief summary
This observational study will be conducted in COPD participants in Tier 2 and 3 hospitals in China to gain an understanding of the complex COPD management and physician's treatment strategy.
Interventions
Prospective observational cohort study. No study treatment was administered in this study.
Sponsors
GlaxoSmithKline
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female participants with minimum 40 years of age. * A diagnosis of COPD confirmed by spirometry (According to Global initiative for chronic obstructive lung disease \[GOLD\] 2019 criteria) in Tier 2 and Tier 3 hospitals. * In hospitalized participants, recruit only participants who receive any intravenous therapy. * A signed and dated written informed consent. * Participants can communicate normally.
Exclusion criteria
* Current primary diagnosis of asthma, active tuberculosis, bronchiectasis, lung cancer or other active pulmonary disease. * Other unstable diseases or cognitive behavior, which could influence CAT and lung function results (judged by physicians). * Experienced a moderate/severe COPD exacerbation treated by a physician within last 1 month. * Currently participating in another COPD clinical study, which provides the participant investigational medication and/or disease management.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Received COPD Prescription for Maintenance Treatment at Baseline | At Baseline (Day 1) | 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). |
| Number of Participants Who Received COPD Prescription for Maintenance Treatment at 3 Months | 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). |
| Number of Participants With Moderate Acute Exacerbation Requiring no Hospitalization by Each COPD Maintenance Treatment at Follow-up (Week 1) | 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). |
| Number of Participants With Acute Exacerbation Requiring Hospitalization by Each COPD Maintenance Treatment at Discharge Follow-up (up to 28 Days) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified Medical Research Council (mMRC) Score by Historic Treatments at Indicated Time Point | At 3 months | 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. |
| Number of Participants Requiring Hospitalization by Their Each Dyspnea, Eosinopenia, Consolidation, Acidemia and Atrial Fibrillation (DECAF) Risk Group | 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. |
| Number of Participants With at Least One Co-morbidity | 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). |
| Number of Participants by Their Socio-economic Characteristics | 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). |
| Mean Forced Expiratory Volume in One Minute (FEV1) at Baseline | 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. |
| Number of Participants by Their Modified British Medical Research Council (mMRC) Score at Baseline | At Baseline (Day 1) | 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. Number of participants by their mMRC scores (Scores 0, 1, 2, 3 and 4) were summarized. Participants who did not provide scores were categorized under Missing. The measurement at Baseline visit (Day 1) was defined as Baseline. |
| Number of Participants Whose Prescribed Maintenance Treatment Was Stepped up, Stepped Down, Stopped, Switched, Remained the Same | 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. |
| Number of Participants Receiving COPD Maintenance Treatment at 3 Months | 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). |
| Number of Participants by Their COPD Assessment Test (CAT) Scores at Indicated Time Points | 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. |
| Number of Participants With History of Exacerbations in Within 1 Year Prior to Baseline | Within 1 year prior to Baseline (Day 1) visit | 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). |
| Number of Participants With COPD Medication History | 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). |
| Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) Scores by Historic Treatments at Indicated Time Point | 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. 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. |
Countries
China
Participant flow
Recruitment details
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).
Pre-assignment details
A total of 1507 participants were enrolled in the study (Enrolled Population: All participants who passed screening \[met eligibility criteria\] and entered the study).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 797 |
| 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. | 71 |
| 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. | 615 |
| Total | 1,483 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 4 | 0 | 2 |
| Overall Study | Lost to Follow-up | 16 | 2 | 37 |
| Overall Study | Physician Decision | 0 | 0 | 2 |
| Overall Study | Poor adherence, unable to cooperate with investigator to complete test | 1 | 1 | 10 |
| Overall Study | Violation of inclusion/exclusion criteria | 3 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 6 | 0 | 21 |
Baseline characteristics
| Characteristic | Cohort 1: Participants Presenting With Stable Disease | Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Total |
|---|---|---|---|---|
| Age, Continuous | 67.1 Years STANDARD_DEVIATION 8.15 | 68.3 Years STANDARD_DEVIATION 8.4 | 69.1 Years STANDARD_DEVIATION 8.28 | 68.0 Years STANDARD_DEVIATION 8.27 |
| Race/Ethnicity, Customized Asian-Chinese | 797 Participants | 71 Participants | 615 Participants | 1483 Participants |
| Sex: Female, Male Female | 94 Participants | 5 Participants | 69 Participants | 168 Participants |
| Sex: Female, Male Male | 703 Participants | 66 Participants | 546 Participants | 1315 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 4 / 797 | 0 / 71 | 2 / 615 |
| other Total, other adverse events | 2 / 797 | 0 / 71 | 0 / 615 |
| serious Total, serious adverse events | 5 / 797 | 1 / 71 | 4 / 615 |
Outcome results
Primary
Number of Participants Who Received COPD Prescription for Maintenance Treatment 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).
Time frame: 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. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants Who Received COPD Prescription for Maintenance Treatment at 3 Months | MITT | 46 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants Who Received COPD Prescription for Maintenance Treatment at 3 Months | Theophylline | 91 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants Who Received COPD Prescription for Maintenance Treatment at 3 Months | MITT or SITT | 287 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants Who Received COPD Prescription for Maintenance Treatment at 3 Months | N-acetyl cysteine/carbocysteine | 69 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants Who Received COPD Prescription for Maintenance Treatment at 3 Months | LABA/LAMA | 138 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants Who Received COPD Prescription for Maintenance Treatment at 3 Months | Use the maintenance treatment | 685 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants Who Received COPD Prescription for Maintenance Treatment at 3 Months | ICS/LABA | 143 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants Who Received COPD Prescription for Maintenance Treatment at 3 Months | LAMA | 95 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants Who Received COPD Prescription for Maintenance Treatment at 3 Months | Triple therapy (ICS/LABA/LAMA, SITT) | 241 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants Who Received COPD Prescription for Maintenance Treatment at 3 Months | LABA | 1 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants Who Received COPD Prescription for Maintenance Treatment at 3 Months | ICS/LABA | 20 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants Who Received COPD Prescription for Maintenance Treatment at 3 Months | LABA | 0 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants Who Received COPD Prescription for Maintenance Treatment at 3 Months | LABA/LAMA | 12 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants Who Received COPD Prescription for Maintenance Treatment at 3 Months | Theophylline | 7 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants Who Received COPD Prescription for Maintenance Treatment at 3 Months | Use the maintenance treatment | 57 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants Who Received COPD Prescription for Maintenance Treatment at 3 Months | Triple therapy (ICS/LABA/LAMA, SITT) | 13 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants Who Received COPD Prescription for Maintenance Treatment at 3 Months | MITT or SITT | 16 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants Who Received COPD Prescription for Maintenance Treatment at 3 Months | MITT | 3 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants Who Received COPD Prescription for Maintenance Treatment at 3 Months | N-acetyl cysteine/carbocysteine | 9 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants Who Received COPD Prescription for Maintenance Treatment at 3 Months | LAMA | 6 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants Who Received COPD Prescription for Maintenance Treatment at 3 Months | N-acetyl cysteine/carbocysteine | 57 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants Who Received COPD Prescription for Maintenance Treatment at 3 Months | LAMA | 26 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants Who Received COPD Prescription for Maintenance Treatment at 3 Months | MITT or SITT | 227 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants Who Received COPD Prescription for Maintenance Treatment at 3 Months | Use the maintenance treatment | 433 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants Who Received COPD Prescription for Maintenance Treatment at 3 Months | LABA | 0 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants Who Received COPD Prescription for Maintenance Treatment at 3 Months | LABA/LAMA | 36 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants Who Received COPD Prescription for Maintenance Treatment at 3 Months | ICS/LABA | 115 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants Who Received COPD Prescription for Maintenance Treatment at 3 Months | Triple therapy (ICS/LABA/LAMA, SITT) | 186 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants Who Received COPD Prescription for Maintenance Treatment at 3 Months | MITT | 41 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants Who Received COPD Prescription for Maintenance Treatment at 3 Months | Theophylline | 80 Participants |
Primary
Number of Participants Who Received COPD Prescription for Maintenance Treatment at Baseline
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).
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants Who Received COPD Prescription for Maintenance Treatment at Baseline | Use the maintenance treatment | 735 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants Who Received COPD Prescription for Maintenance Treatment at Baseline | LAMA | 105 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants Who Received COPD Prescription for Maintenance Treatment at Baseline | LABA | 1 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants Who Received COPD Prescription for Maintenance Treatment at Baseline | LABA/LAMA | 164 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants Who Received COPD Prescription for Maintenance Treatment at Baseline | ICS/LABA | 165 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants Who Received COPD Prescription for Maintenance Treatment at Baseline | Triple therapy (ICS/LABA/LAMA, SITT) | 225 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants Who Received COPD Prescription for Maintenance Treatment at Baseline | MITT | 55 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants Who Received COPD Prescription for Maintenance Treatment at Baseline | Theophylline | 117 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants Who Received COPD Prescription for Maintenance Treatment at Baseline | MITT or SITT | 280 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants Who Received COPD Prescription for Maintenance Treatment at Baseline | N-acetyl cysteine/carbocysteine | 81 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants Who Received COPD Prescription for Maintenance Treatment at Baseline | MITT or SITT | 23 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants Who Received COPD Prescription for Maintenance Treatment at Baseline | Use the maintenance treatment | 68 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants Who Received COPD Prescription for Maintenance Treatment at Baseline | Triple therapy (ICS/LABA/LAMA, SITT) | 17 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants Who Received COPD Prescription for Maintenance Treatment at Baseline | ICS/LABA | 20 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants Who Received COPD Prescription for Maintenance Treatment at Baseline | LAMA | 3 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants Who Received COPD Prescription for Maintenance Treatment at Baseline | N-acetyl cysteine/carbocysteine | 16 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants Who Received COPD Prescription for Maintenance Treatment at Baseline | Theophylline | 12 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants Who Received COPD Prescription for Maintenance Treatment at Baseline | LABA | 0 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants Who Received COPD Prescription for Maintenance Treatment at Baseline | MITT | 6 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants Who Received COPD Prescription for Maintenance Treatment at Baseline | LABA/LAMA | 16 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants Who Received COPD Prescription for Maintenance Treatment at Baseline | Theophylline | 427 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants Who Received COPD Prescription for Maintenance Treatment at Baseline | LABA/LAMA | 34 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants Who Received COPD Prescription for Maintenance Treatment at Baseline | ICS/LABA | 107 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants Who Received COPD Prescription for Maintenance Treatment at Baseline | Triple therapy (ICS/LABA/LAMA, SITT) | 126 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants Who Received COPD Prescription for Maintenance Treatment at Baseline | MITT or SITT | 169 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants Who Received COPD Prescription for Maintenance Treatment at Baseline | MITT | 43 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants Who Received COPD Prescription for Maintenance Treatment at Baseline | Use the maintenance treatment | 554 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants Who Received COPD Prescription for Maintenance Treatment at Baseline | N-acetyl cysteine/carbocysteine | 240 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants Who Received COPD Prescription for Maintenance Treatment at Baseline | LAMA | 13 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants Who Received COPD Prescription for Maintenance Treatment at Baseline | LABA | 0 Participants |
Primary
Number of Participants With Acute Exacerbation Requiring Hospitalization by Each COPD Maintenance Treatment 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).
Time frame: At Discharge follow-up (up to 28 days)
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Participants Presenting With Stable Disease | 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 |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants With Acute Exacerbation Requiring Hospitalization by Each COPD Maintenance Treatment at Discharge Follow-up (up to 28 Days) | MITT | 51 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants With Acute Exacerbation Requiring Hospitalization by Each COPD Maintenance Treatment at Discharge Follow-up (up to 28 Days) | Theophylline | 164 Participants |
| Cohort 1: Participants Presenting With Stable Disease | 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 |
| Cohort 1: Participants Presenting With Stable Disease | 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 |
| Cohort 1: Participants Presenting With Stable Disease | 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 |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants With Acute Exacerbation Requiring Hospitalization by Each COPD Maintenance Treatment at Discharge Follow-up (up to 28 Days) | LAMA | 29 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants With Acute Exacerbation Requiring Hospitalization by Each COPD Maintenance Treatment at Discharge Follow-up (up to 28 Days) | LABA | 0 Participants |
| Cohort 1: Participants Presenting With Stable Disease | 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 |
| Cohort 1: Participants Presenting With Stable Disease | 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 |
Primary
Number of Participants With Moderate Acute Exacerbation Requiring no Hospitalization by Each COPD Maintenance Treatment at Follow-up (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).
Time frame: At Week 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Participants Presenting With Stable Disease | 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 |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants With Moderate Acute Exacerbation Requiring no Hospitalization by Each COPD Maintenance Treatment at Follow-up (Week 1) | LAMA | 3 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants With Moderate Acute Exacerbation Requiring no Hospitalization by Each COPD Maintenance Treatment at Follow-up (Week 1) | LABA | 0 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants With Moderate Acute Exacerbation Requiring no Hospitalization by Each COPD Maintenance Treatment at Follow-up (Week 1) | LABA/LAMA | 1 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants With Moderate Acute Exacerbation Requiring no Hospitalization by Each COPD Maintenance Treatment at Follow-up (Week 1) | ICS/LABA | 3 Participants |
| Cohort 1: Participants Presenting With Stable Disease | 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 |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants With Moderate Acute Exacerbation Requiring no Hospitalization by Each COPD Maintenance Treatment at Follow-up (Week 1) | MITT | 0 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants With Moderate Acute Exacerbation Requiring no Hospitalization by Each COPD Maintenance Treatment at Follow-up (Week 1) | Theophylline | 5 Participants |
| Cohort 1: Participants Presenting With Stable Disease | 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 |
| Cohort 1: Participants Presenting With Stable Disease | 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 |
Secondary
Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) Scores by Historic Treatments at Indicated Time Point
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Participants Presenting With Stable Disease | 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 |
| Cohort 1: Participants Presenting With Stable Disease | Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) Scores by Historic Treatments at Indicated Time Point | LABA | 27.0 Scores on a scale | — |
| Cohort 1: Participants Presenting With Stable Disease | 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 |
| Cohort 1: Participants Presenting With Stable Disease | 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 |
| Cohort 1: Participants Presenting With Stable Disease | 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 |
| Cohort 1: Participants Presenting With Stable Disease | 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 |
| Cohort 1: Participants Presenting With Stable Disease | 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 |
| Cohort 1: Participants Presenting With Stable Disease | 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 |
| Cohort 1: Participants Presenting With Stable Disease | 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 |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) Scores by Historic Treatments at Indicated Time Point | Theophylline | 11.6 Scores on a scale | Standard Deviation 6.32 |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) Scores by Historic Treatments at Indicated Time Point | MITT | 15.8 Scores on a scale | Standard Deviation 6.02 |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) Scores by Historic Treatments at Indicated Time Point | LABA/LAMA | 16.8 Scores on a scale | Standard Deviation 8.06 |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) Scores by Historic Treatments at Indicated Time Point | Triple therapy (ICS/LABA/LAMA, SITT) | 14.4 Scores on a scale | Standard Deviation 8.04 |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) Scores by Historic Treatments at Indicated Time Point | N-acetyl cysteine/carbocysteine | 14.3 Scores on a scale | Standard Deviation 9.54 |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) Scores by Historic Treatments at Indicated Time Point | ICS/LABA | 14.3 Scores on a scale | Standard Deviation 5.07 |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) Scores by Historic Treatments at Indicated Time Point | MITT or SITT | 14.9 Scores on a scale | Standard Deviation 7.08 |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) Scores by Historic Treatments at Indicated Time Point | LABA/LAMA | 18.7 Scores on a scale | Standard Deviation 6.54 |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) Scores by Historic Treatments at Indicated Time Point | ICS/LABA | 18.0 Scores on a scale | Standard Deviation 8.43 |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) Scores by Historic Treatments at Indicated Time Point | Triple therapy (ICS/LABA/LAMA, SITT) | 21.5 Scores on a scale | Standard Deviation 8.12 |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) Scores by Historic Treatments at Indicated Time Point | MITT or SITT | 21.2 Scores on a scale | Standard Deviation 7.9 |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) Scores by Historic Treatments at Indicated Time Point | MITT | 20.6 Scores on a scale | Standard Deviation 7.49 |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) Scores by Historic Treatments at Indicated Time Point | N-acetyl cysteine/carbocysteine | 19.3 Scores on a scale | Standard Deviation 8.6 |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) Scores by Historic Treatments at Indicated Time Point | LAMA | 19.5 Scores on a scale | Standard Deviation 6.73 |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) Scores by Historic Treatments at Indicated Time Point | Theophylline | 19.4 Scores on a scale | Standard Deviation 8.3 |
Secondary
Mean Forced Expiratory Volume in One Minute (FEV1) at Baseline
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Participants Presenting With Stable Disease | Mean Forced Expiratory Volume in One Minute (FEV1) at Baseline | 1.424 Liters | Standard Deviation 0.6313 |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Mean Forced Expiratory Volume in One Minute (FEV1) at Baseline | 1.405 Liters | Standard Deviation 0.6178 |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Mean Forced Expiratory Volume in One Minute (FEV1) at Baseline | 1.137 Liters | Standard Deviation 0.5312 |
Secondary
Modified Medical Research Council (mMRC) Score by Historic Treatments at Indicated Time Point
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Participants Presenting With Stable Disease | Modified Medical Research Council (mMRC) Score by Historic Treatments at Indicated Time Point | LAMA | 1.2 Scores on a scale | Standard Deviation 0.91 |
| Cohort 1: Participants Presenting With Stable Disease | Modified Medical Research Council (mMRC) Score by Historic Treatments at Indicated Time Point | LABA | 2.0 Scores on a scale | — |
| Cohort 1: Participants Presenting With Stable Disease | 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 |
| Cohort 1: Participants Presenting With Stable Disease | 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 |
| Cohort 1: Participants Presenting With Stable Disease | 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 |
| Cohort 1: Participants Presenting With Stable Disease | Modified Medical Research Council (mMRC) Score by Historic Treatments at Indicated Time Point | MITT | 1.8 Scores on a scale | Standard Deviation 1.03 |
| Cohort 1: Participants Presenting With Stable Disease | Modified Medical Research Council (mMRC) Score by Historic Treatments at Indicated Time Point | Theophylline | 1.7 Scores on a scale | Standard Deviation 0.99 |
| Cohort 1: Participants Presenting With Stable Disease | 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 |
| Cohort 1: Participants Presenting With Stable Disease | 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 |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Modified Medical Research Council (mMRC) Score by Historic Treatments at Indicated Time Point | Theophylline | 1.7 Scores on a scale | Standard Deviation 0.95 |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Modified Medical Research Council (mMRC) Score by Historic Treatments at Indicated Time Point | MITT | 2.3 Scores on a scale | Standard Deviation 0.96 |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Modified Medical Research Council (mMRC) Score by Historic Treatments at Indicated Time Point | LABA/LAMA | 1.8 Scores on a scale | Standard Deviation 0.98 |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Modified Medical Research Council (mMRC) Score by Historic Treatments at Indicated Time Point | Triple therapy (ICS/LABA/LAMA, SITT) | 1.9 Scores on a scale | Standard Deviation 0.69 |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Modified Medical Research Council (mMRC) Score by Historic Treatments at Indicated Time Point | N-acetyl cysteine/carbocysteine | 2.3 Scores on a scale | Standard Deviation 1.03 |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Modified Medical Research Council (mMRC) Score by Historic Treatments at Indicated Time Point | ICS/LABA | 1.2 Scores on a scale | Standard Deviation 1.19 |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Modified Medical Research Council (mMRC) Score by Historic Treatments at Indicated Time Point | MITT or SITT | 2.0 Scores on a scale | Standard Deviation 0.77 |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Modified Medical Research Council (mMRC) Score by Historic Treatments at Indicated Time Point | LABA/LAMA | 2.0 Scores on a scale | Standard Deviation 1.17 |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Modified Medical Research Council (mMRC) Score by Historic Treatments at Indicated Time Point | ICS/LABA | 2.1 Scores on a scale | Standard Deviation 1.08 |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Modified Medical Research Council (mMRC) Score by Historic Treatments at Indicated Time Point | Triple therapy (ICS/LABA/LAMA, SITT) | 2.4 Scores on a scale | Standard Deviation 1.03 |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Modified Medical Research Council (mMRC) Score by Historic Treatments at Indicated Time Point | MITT or SITT | 2.4 Scores on a scale | Standard Deviation 1.04 |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Modified Medical Research Council (mMRC) Score by Historic Treatments at Indicated Time Point | MITT | 2.4 Scores on a scale | Standard Deviation 1.09 |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Modified Medical Research Council (mMRC) Score by Historic Treatments at Indicated Time Point | N-acetyl cysteine/carbocysteine | 1.9 Scores on a scale | Standard Deviation 1.14 |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Modified Medical Research Council (mMRC) Score by Historic Treatments at Indicated Time Point | LAMA | 2.1 Scores on a scale | Standard Deviation 0.92 |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Modified Medical Research Council (mMRC) Score by Historic Treatments at Indicated Time Point | Theophylline | 2.2 Scores on a scale | Standard Deviation 1.08 |
Secondary
Number of Participants by Their COPD Assessment Test (CAT) Scores at Indicated 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. 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.
Time frame: Baseline (Day 1), Week 1, Discharge follow-up (up to 28 days) and 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. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants by Their COPD Assessment Test (CAT) Scores at Indicated Time Points | At 3 months; Score <=10 | 420 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants by Their COPD Assessment Test (CAT) Scores at Indicated Time Points | At 3 months; Score 11 to 20 | 238 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants by Their COPD Assessment Test (CAT) Scores at Indicated Time Points | Baseline (Day 1); Missing | 1 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants by Their COPD Assessment Test (CAT) Scores at Indicated Time Points | At 3 months; Score 21 to 30 | 90 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants by Their COPD Assessment Test (CAT) Scores at Indicated Time Points | At 3 months; Score 31 to 40 | 21 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants by Their COPD Assessment Test (CAT) Scores at Indicated Time Points | At 3 months; Missing | 28 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants by Their COPD Assessment Test (CAT) Scores at Indicated Time Points | Baseline (Day 1); Score <=10 | 300 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants by Their COPD Assessment Test (CAT) Scores at Indicated Time Points | Baseline (Day 1); Scores 21 to 30 | 148 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants by Their COPD Assessment Test (CAT) Scores at Indicated Time Points | Baseline (Day 1); Scores 11 to 20 | 318 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants by Their COPD Assessment Test (CAT) Scores at Indicated Time Points | Baseline (Day 1); Scores 31 to 40 | 30 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants by Their COPD Assessment Test (CAT) Scores at Indicated Time Points | At 3 months; Score 31 to 40 | 1 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants by Their COPD Assessment Test (CAT) Scores at Indicated Time Points | Baseline (Day 1); Score <=10 | 20 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants by Their COPD Assessment Test (CAT) Scores at Indicated Time Points | Baseline (Day 1); Scores 31 to 40 | 1 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants by Their COPD Assessment Test (CAT) Scores at Indicated Time Points | At 3 months; Missing | 4 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants by Their COPD Assessment Test (CAT) Scores at Indicated Time Points | Baseline (Day 1); Scores 21 to 30 | 18 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants by Their COPD Assessment Test (CAT) Scores at Indicated Time Points | Week 1; Score <=10 | 31 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants by Their COPD Assessment Test (CAT) Scores at Indicated Time Points | At 3 months; Score <=10 | 38 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants by Their COPD Assessment Test (CAT) Scores at Indicated Time Points | Baseline (Day 1); Scores 11 to 20 | 32 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants by Their COPD Assessment Test (CAT) Scores at Indicated Time Points | Week 1; Scores 11 to 20 | 24 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants by Their COPD Assessment Test (CAT) Scores at Indicated Time Points | At 3 months; Score 11 to 20 | 21 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants by Their COPD Assessment Test (CAT) Scores at Indicated Time Points | Week 1; Scores 21 to 30 | 12 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants by Their COPD Assessment Test (CAT) Scores at Indicated Time Points | Week 1; Scores 31 to 40 | 1 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants by Their COPD Assessment Test (CAT) Scores at Indicated Time Points | At 3 months; Score 21 to 30 | 7 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants by Their COPD Assessment Test (CAT) Scores at Indicated Time Points | Baseline (Day 1); Missing | 0 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants by Their COPD Assessment Test (CAT) Scores at Indicated Time Points | Week 1; Missing | 3 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants by Their COPD Assessment Test (CAT) Scores at Indicated Time Points | At 3 months; Missing | 70 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants by Their COPD Assessment Test (CAT) Scores at Indicated Time Points | Baseline (Day 1); Score <=10 | 109 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants by Their COPD Assessment Test (CAT) Scores at Indicated Time Points | Baseline (Day 1); Scores 11 to 20 | 250 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants by Their COPD Assessment Test (CAT) Scores at Indicated Time Points | Baseline (Day 1); Scores 21 to 30 | 199 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants by Their COPD Assessment Test (CAT) Scores at Indicated Time Points | Baseline (Day 1); Scores 31 to 40 | 52 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants by Their COPD Assessment Test (CAT) Scores at Indicated Time Points | Baseline (Day 1); Missing | 5 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | 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 |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | 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 |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | 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 |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | 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 |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants by Their COPD Assessment Test (CAT) Scores at Indicated Time Points | Discharge follow-up (up to 28 days); Missing | 26 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants by Their COPD Assessment Test (CAT) Scores at Indicated Time Points | At 3 months; Score <=10 | 239 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants by Their COPD Assessment Test (CAT) Scores at Indicated Time Points | At 3 months; Score 11 to 20 | 213 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants by Their COPD Assessment Test (CAT) Scores at Indicated Time Points | At 3 months; Score 21 to 30 | 71 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants by Their COPD Assessment Test (CAT) Scores at Indicated Time Points | At 3 months; Score 31 to 40 | 22 Participants |
Secondary
Number of Participants by Their Modified British Medical Research Council (mMRC) Score at Baseline
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. Number of participants by their mMRC scores (Scores 0, 1, 2, 3 and 4) were summarized. Participants who did not provide scores were categorized under Missing. The measurement at Baseline visit (Day 1) was defined as Baseline.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants by Their Modified British Medical Research Council (mMRC) Score at Baseline | Score 0 | 127 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants by Their Modified British Medical Research Council (mMRC) Score at Baseline | Score 1 | 279 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants by Their Modified British Medical Research Council (mMRC) Score at Baseline | Score 2 | 258 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants by Their Modified British Medical Research Council (mMRC) Score at Baseline | Score 3 | 118 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants by Their Modified British Medical Research Council (mMRC) Score at Baseline | Score 4 | 14 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants by Their Modified British Medical Research Council (mMRC) Score at Baseline | Missing | 1 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants by Their Modified British Medical Research Council (mMRC) Score at Baseline | Missing | 0 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants by Their Modified British Medical Research Council (mMRC) Score at Baseline | Score 0 | 14 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants by Their Modified British Medical Research Council (mMRC) Score at Baseline | Score 3 | 13 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants by Their Modified British Medical Research Council (mMRC) Score at Baseline | Score 4 | 3 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants by Their Modified British Medical Research Council (mMRC) Score at Baseline | Score 1 | 17 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants by Their Modified British Medical Research Council (mMRC) Score at Baseline | Score 2 | 24 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants by Their Modified British Medical Research Council (mMRC) Score at Baseline | Score 1 | 130 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants by Their Modified British Medical Research Council (mMRC) Score at Baseline | Score 2 | 202 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants by Their Modified British Medical Research Council (mMRC) Score at Baseline | Missing | 5 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants by Their Modified British Medical Research Council (mMRC) Score at Baseline | Score 3 | 163 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants by Their Modified British Medical Research Council (mMRC) Score at Baseline | Score 0 | 37 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants by Their Modified British Medical Research Council (mMRC) Score at Baseline | Score 4 | 78 Participants |
Secondary
Number of Participants by Their Socio-economic Characteristics
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).
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants by Their Socio-economic Characteristics | National basic medical insurance; Urban resident medical insurance | 111 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants by Their Socio-economic Characteristics | National basic medical insurance; Urban and rural resident basic medical insurance | 89 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants by Their Socio-economic Characteristics | Education; No formal education | 38 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants by Their Socio-economic Characteristics | Education; Elementary school | 219 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants by Their Socio-economic Characteristics | Education; Middle school | 286 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants by Their Socio-economic Characteristics | Education; High school-including vocational school | 167 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants by Their Socio-economic Characteristics | Education; Bachelor's degree and above | 85 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants by Their Socio-economic Characteristics | Education; Missing | 2 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants by Their Socio-economic Characteristics | Local permanent resident; No | 69 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants by Their Socio-economic Characteristics | Local permanent resident; Yes | 726 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants by Their Socio-economic Characteristics | Local permanent resident; Missing | 2 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants by Their Socio-economic Characteristics | Marriage condition; Married | 717 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants by Their Socio-economic Characteristics | Marriage condition; Divorced/Separated | 19 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants by Their Socio-economic Characteristics | Marriage condition; Widowed | 54 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants by Their Socio-economic Characteristics | Marriage condition; Unmarried | 5 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants by Their Socio-economic Characteristics | Marriage condition; Missing | 2 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants by Their Socio-economic Characteristics | With whom usually live; Live alone | 84 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants by Their Socio-economic Characteristics | With whom usually live; With spouse | 612 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants by Their Socio-economic Characteristics | With whom usually live; Take turns in different children's homes | 5 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants by Their Socio-economic Characteristics | With whom usually live; Other relatives | 7 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants by Their Socio-economic Characteristics | With whom usually live; Missing | 2 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants by Their Socio-economic Characteristics | National basic medical insurance; None | 9 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants by Their Socio-economic Characteristics | National basic medical insurance; Government medical insurance | 13 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants by Their Socio-economic Characteristics | National basic medical insurance; Urban employee medical insurance | 395 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants by Their Socio-economic Characteristics | With whom usually live; With one specific child | 175 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants by Their Socio-economic Characteristics | National basic medical insurance; New cooperative medical insurance | 176 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants by Their Socio-economic Characteristics | National basic medical insurance; Serious illness insurance | 2 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants by Their Socio-economic Characteristics | National basic medical insurance; Missing | 2 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants by Their Socio-economic Characteristics | Commercial insurance; No | 727 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants by Their Socio-economic Characteristics | Commercial insurance; Yes | 68 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants by Their Socio-economic Characteristics | Commercial insurance; Missing | 2 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants by Their Socio-economic Characteristics | National basic medical insurance; Urban employee medical insurance | 28 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants by Their Socio-economic Characteristics | Marriage condition; Married | 66 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants by Their Socio-economic Characteristics | National basic medical insurance; New cooperative medical insurance | 11 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants by Their Socio-economic Characteristics | Marriage condition; Divorced/Separated | 2 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants by Their Socio-economic Characteristics | Marriage condition; Widowed | 3 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants by Their Socio-economic Characteristics | National basic medical insurance; Urban and rural resident basic medical insurance | 19 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants by Their Socio-economic Characteristics | Marriage condition; Unmarried | 0 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants by Their Socio-economic Characteristics | Marriage condition; Missing | 0 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants by Their Socio-economic Characteristics | Commercial insurance; Yes | 6 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants by Their Socio-economic Characteristics | With whom usually live; Live alone | 7 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants by Their Socio-economic Characteristics | National basic medical insurance; Serious illness insurance | 0 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants by Their Socio-economic Characteristics | With whom usually live; With spouse | 53 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants by Their Socio-economic Characteristics | With whom usually live; With one specific child | 21 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants by Their Socio-economic Characteristics | With whom usually live; Take turns in different children's homes | 0 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants by Their Socio-economic Characteristics | National basic medical insurance; Missing | 0 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants by Their Socio-economic Characteristics | With whom usually live; Missing | 0 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants by Their Socio-economic Characteristics | National basic medical insurance; None | 1 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants by Their Socio-economic Characteristics | With whom usually live; Other relatives | 0 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants by Their Socio-economic Characteristics | Education; No formal education | 1 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants by Their Socio-economic Characteristics | National basic medical insurance; Government medical insurance | 2 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants by Their Socio-economic Characteristics | Education; Elementary school | 27 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants by Their Socio-economic Characteristics | Education; Middle school | 24 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants by Their Socio-economic Characteristics | Commercial insurance; No | 65 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants by Their Socio-economic Characteristics | Education; High school-including vocational school | 15 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants by Their Socio-economic Characteristics | Commercial insurance; Missing | 0 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants by Their Socio-economic Characteristics | Education; Bachelor's degree and above | 4 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants by Their Socio-economic Characteristics | Education; Missing | 0 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants by Their Socio-economic Characteristics | Local permanent resident; No | 7 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants by Their Socio-economic Characteristics | National basic medical insurance; Urban resident medical insurance | 10 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants by Their Socio-economic Characteristics | Local permanent resident; Yes | 64 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants by Their Socio-economic Characteristics | Local permanent resident; Missing | 0 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants by Their Socio-economic Characteristics | Local permanent resident; No | 89 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants by Their Socio-economic Characteristics | National basic medical insurance; Urban resident medical insurance | 99 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants by Their Socio-economic Characteristics | Marriage condition; Married | 516 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants by Their Socio-economic Characteristics | With whom usually live; Other relatives | 0 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants by Their Socio-economic Characteristics | National basic medical insurance; None | 3 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants by Their Socio-economic Characteristics | Marriage condition; Divorced/Separated | 14 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants by Their Socio-economic Characteristics | National basic medical insurance; New cooperative medical insurance | 195 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants by Their Socio-economic Characteristics | Commercial insurance; Missing | 9 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants by Their Socio-economic Characteristics | Marriage condition; Widowed | 71 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants by Their Socio-economic Characteristics | Education; Bachelor's degree and above | 48 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants by Their Socio-economic Characteristics | Education; No formal education | 40 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants by Their Socio-economic Characteristics | Marriage condition; Unmarried | 6 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants by Their Socio-economic Characteristics | National basic medical insurance; Urban and rural resident basic medical insurance | 31 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants by Their Socio-economic Characteristics | National basic medical insurance; Urban employee medical insurance | 260 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants by Their Socio-economic Characteristics | Marriage condition; Missing | 8 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants by Their Socio-economic Characteristics | Local permanent resident; Missing | 8 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants by Their Socio-economic Characteristics | Education; Elementary school | 187 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants by Their Socio-economic Characteristics | With whom usually live; Live alone | 64 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants by Their Socio-economic Characteristics | National basic medical insurance; Government medical insurance | 14 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants by Their Socio-economic Characteristics | Education; Missing | 8 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants by Their Socio-economic Characteristics | With whom usually live; With spouse | 415 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants by Their Socio-economic Characteristics | Education; Middle school | 214 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants by Their Socio-economic Characteristics | With whom usually live; With one specific child | 173 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants by Their Socio-economic Characteristics | National basic medical insurance; Serious illness insurance | 2 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants by Their Socio-economic Characteristics | Commercial insurance; No | 564 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants by Their Socio-economic Characteristics | With whom usually live; Take turns in different children's homes | 9 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants by Their Socio-economic Characteristics | Commercial insurance; Yes | 42 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants by Their Socio-economic Characteristics | Local permanent resident; Yes | 518 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants by Their Socio-economic Characteristics | Education; High school-including vocational school | 118 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants by Their Socio-economic Characteristics | With whom usually live; Missing | 8 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants by Their Socio-economic Characteristics | National basic medical insurance; Missing | 11 Participants |
Secondary
Number of Participants Receiving COPD Maintenance Treatment 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).
Time frame: 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. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants Receiving COPD Maintenance Treatment at 3 Months | N-acetyl cysteine/carbocysteine | 80 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants Receiving COPD Maintenance Treatment at 3 Months | Theophylline | 93 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants Receiving COPD Maintenance Treatment at 3 Months | Triple therapy (ICS/LABA/LAMA, SITT) | 240 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants Receiving COPD Maintenance Treatment at 3 Months | MITT | 51 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants Receiving COPD Maintenance Treatment at 3 Months | LABA/LAMA | 127 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants Receiving COPD Maintenance Treatment at 3 Months | LAMA | 92 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants Receiving COPD Maintenance Treatment at 3 Months | MITT or SITT | 291 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants Receiving COPD Maintenance Treatment at 3 Months | ICS/LABA | 136 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants Receiving COPD Maintenance Treatment at 3 Months | Triple therapy (ICS/LABA/LAMA, SITT) | 11 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants Receiving COPD Maintenance Treatment at 3 Months | LAMA | 6 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants Receiving COPD Maintenance Treatment at 3 Months | LABA/LAMA | 12 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants Receiving COPD Maintenance Treatment at 3 Months | ICS/LABA | 21 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants Receiving COPD Maintenance Treatment at 3 Months | MITT | 4 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants Receiving COPD Maintenance Treatment at 3 Months | Theophylline | 6 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants Receiving COPD Maintenance Treatment at 3 Months | MITT or SITT | 15 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants Receiving COPD Maintenance Treatment at 3 Months | N-acetyl cysteine/carbocysteine | 7 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants Receiving COPD Maintenance Treatment at 3 Months | LAMA | 20 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants Receiving COPD Maintenance Treatment at 3 Months | Theophylline | 82 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants Receiving COPD Maintenance Treatment at 3 Months | LABA/LAMA | 35 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants Receiving COPD Maintenance Treatment at 3 Months | N-acetyl cysteine/carbocysteine | 52 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants Receiving COPD Maintenance Treatment at 3 Months | Triple therapy (ICS/LABA/LAMA, SITT) | 181 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants Receiving COPD Maintenance Treatment at 3 Months | MITT or SITT | 227 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants Receiving COPD Maintenance Treatment at 3 Months | MITT | 46 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants Receiving COPD Maintenance Treatment at 3 Months | ICS/LABA | 109 Participants |
Secondary
Number of Participants Requiring Hospitalization by Their Each Dyspnea, Eosinopenia, Consolidation, Acidemia and Atrial Fibrillation (DECAF) Risk Group
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants Requiring Hospitalization by Their Each Dyspnea, Eosinopenia, Consolidation, Acidemia and Atrial Fibrillation (DECAF) Risk Group | Mild | 503 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants Requiring Hospitalization by Their Each Dyspnea, Eosinopenia, Consolidation, Acidemia and Atrial Fibrillation (DECAF) Risk Group | Moderate | 49 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants Requiring Hospitalization by Their Each Dyspnea, Eosinopenia, Consolidation, Acidemia and Atrial Fibrillation (DECAF) Risk Group | Severe | 5 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants Requiring Hospitalization by Their Each Dyspnea, Eosinopenia, Consolidation, Acidemia and Atrial Fibrillation (DECAF) Risk Group | Missing | 58 Participants |
Secondary
Number of Participants Whose Prescribed Maintenance Treatment Was Stepped up, Stepped Down, Stopped, Switched, Remained the Same
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.
Time frame: Up to 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. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants Whose Prescribed Maintenance Treatment Was Stepped up, Stepped Down, Stopped, Switched, Remained the Same | Stepped up | 67 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants Whose Prescribed Maintenance Treatment Was Stepped up, Stepped Down, Stopped, Switched, Remained the Same | Stepped down | 26 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants Whose Prescribed Maintenance Treatment Was Stepped up, Stepped Down, Stopped, Switched, Remained the Same | Stopped | 25 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants Whose Prescribed Maintenance Treatment Was Stepped up, Stepped Down, Stopped, Switched, Remained the Same | Switched | 9 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants Whose Prescribed Maintenance Treatment Was Stepped up, Stepped Down, Stopped, Switched, Remained the Same | Remained the same | 568 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants Whose Prescribed Maintenance Treatment Was Stepped up, Stepped Down, Stopped, Switched, Remained the Same | Missing | 102 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants Whose Prescribed Maintenance Treatment Was Stepped up, Stepped Down, Stopped, Switched, Remained the Same | Missing | 34 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants Whose Prescribed Maintenance Treatment Was Stepped up, Stepped Down, Stopped, Switched, Remained the Same | Stepped up | 4 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants Whose Prescribed Maintenance Treatment Was Stepped up, Stepped Down, Stopped, Switched, Remained the Same | Switched | 1 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants Whose Prescribed Maintenance Treatment Was Stepped up, Stepped Down, Stopped, Switched, Remained the Same | Remained the same | 30 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants Whose Prescribed Maintenance Treatment Was Stepped up, Stepped Down, Stopped, Switched, Remained the Same | Stepped down | 1 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants Whose Prescribed Maintenance Treatment Was Stepped up, Stepped Down, Stopped, Switched, Remained the Same | Stopped | 1 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants Whose Prescribed Maintenance Treatment Was Stepped up, Stepped Down, Stopped, Switched, Remained the Same | Stepped down | 14 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants Whose Prescribed Maintenance Treatment Was Stepped up, Stepped Down, Stopped, Switched, Remained the Same | Stopped | 18 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants Whose Prescribed Maintenance Treatment Was Stepped up, Stepped Down, Stopped, Switched, Remained the Same | Missing | 217 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants Whose Prescribed Maintenance Treatment Was Stepped up, Stepped Down, Stopped, Switched, Remained the Same | Switched | 0 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants Whose Prescribed Maintenance Treatment Was Stepped up, Stepped Down, Stopped, Switched, Remained the Same | Stepped up | 180 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants Whose Prescribed Maintenance Treatment Was Stepped up, Stepped Down, Stopped, Switched, Remained the Same | Remained the same | 186 Participants |
Secondary
Number of Participants With at Least One Co-morbidity
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).
Time frame: Up to 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. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants With at Least One Co-morbidity | 512 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants With at Least One Co-morbidity | 52 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants With at Least One Co-morbidity | 571 Participants |
Secondary
Number of Participants With COPD Medication History
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).
Time frame: At Pre-Baseline (Within 1 month before 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. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants With COPD Medication History | LABA | 1 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants With COPD Medication History | Use the maintenance treatment | 523 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants With COPD Medication History | LAMA | 75 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants With COPD Medication History | LABA/LAMA | 108 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants With COPD Medication History | ICS/LABA | 136 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants With COPD Medication History | Triple therapy (ICS/LABA/LAMA, SITT) | 134 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants With COPD Medication History | MITT | 49 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants With COPD Medication History | Theophylline | 105 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants With COPD Medication History | MITT or SITT | 183 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants With COPD Medication History | N-acetyl cysteine/carbocysteine | 73 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants With COPD Medication History | MITT or SITT | 11 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants With COPD Medication History | Triple therapy (ICS/LABA/LAMA, SITT) | 7 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants With COPD Medication History | Use the maintenance treatment | 38 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants With COPD Medication History | ICS/LABA | 12 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants With COPD Medication History | Theophylline | 7 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants With COPD Medication History | LAMA | 0 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants With COPD Medication History | N-acetyl cysteine/carbocysteine | 6 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants With COPD Medication History | LABA | 0 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants With COPD Medication History | MITT | 4 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants With COPD Medication History | LABA/LAMA | 11 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants With COPD Medication History | Theophylline | 330 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants With COPD Medication History | LABA/LAMA | 26 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants With COPD Medication History | ICS/LABA | 92 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants With COPD Medication History | Triple therapy (ICS/LABA/LAMA, SITT) | 98 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants With COPD Medication History | MITT or SITT | 148 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants With COPD Medication History | MITT | 50 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants With COPD Medication History | N-acetyl cysteine/carbocysteine | 175 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants With COPD Medication History | Use the maintenance treatment | 476 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants With COPD Medication History | LAMA | 15 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants With COPD Medication History | LABA | 0 Participants |
Secondary
Number of Participants With History of Exacerbations in Within 1 Year Prior to Baseline
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).
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants With History of Exacerbations in Within 1 Year Prior to Baseline | LAMA | 13 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants With History of Exacerbations in Within 1 Year Prior to Baseline | LABA | 0 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants With History of Exacerbations in Within 1 Year Prior to Baseline | LABA/LAMA | 36 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants With History of Exacerbations in Within 1 Year Prior to Baseline | ICS/LABA | 46 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants With History of Exacerbations in Within 1 Year Prior to Baseline | Triple therapy (ICS/LABA/LAMA, SITT) | 52 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants With History of Exacerbations in Within 1 Year Prior to Baseline | MITT | 22 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants With History of Exacerbations in Within 1 Year Prior to Baseline | Theophylline | 45 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants With History of Exacerbations in Within 1 Year Prior to Baseline | MITT or SITT | 74 Participants |
| Cohort 1: Participants Presenting With Stable Disease | Number of Participants With History of Exacerbations in Within 1 Year Prior to Baseline | N-acetyl cysteine/carbocysteine | 27 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants With History of Exacerbations in Within 1 Year Prior to Baseline | Theophylline | 7 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants With History of Exacerbations in Within 1 Year Prior to Baseline | MITT | 4 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants With History of Exacerbations in Within 1 Year Prior to Baseline | LABA/LAMA | 11 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants With History of Exacerbations in Within 1 Year Prior to Baseline | Triple therapy (ICS/LABA/LAMA, SITT) | 7 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants With History of Exacerbations in Within 1 Year Prior to Baseline | N-acetyl cysteine/carbocysteine | 6 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants With History of Exacerbations in Within 1 Year Prior to Baseline | ICS/LABA | 12 Participants |
| Cohort 2: Participants Presenting With a Moderate Acute Exacerbation Not Requiring Hospitalization | Number of Participants With History of Exacerbations in Within 1 Year Prior to Baseline | MITT or SITT | 11 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants With History of Exacerbations in Within 1 Year Prior to Baseline | LABA/LAMA | 26 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants With History of Exacerbations in Within 1 Year Prior to Baseline | ICS/LABA | 92 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants With History of Exacerbations in Within 1 Year Prior to Baseline | Triple therapy (ICS/LABA/LAMA, SITT) | 97 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants With History of Exacerbations in Within 1 Year Prior to Baseline | MITT or SITT | 147 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants With History of Exacerbations in Within 1 Year Prior to Baseline | MITT | 50 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants With History of Exacerbations in Within 1 Year Prior to Baseline | N-acetyl cysteine/carbocysteine | 174 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants With History of Exacerbations in Within 1 Year Prior to Baseline | LAMA | 15 Participants |
| Cohort 3: Participants Requiring Hospitalization for an Acute Exacerbation | Number of Participants With History of Exacerbations in Within 1 Year Prior to Baseline | Theophylline | 326 Participants |