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

Study Overview
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Brief Summary
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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.

Official Title
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COPD Disease Burden, Patient Characteristics, Maintenance Treatment Patterns and Factors Influencing Treatment Decisions in China Tier 2 and Tier 3 Hospitals

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Other: Prospective observational cohort study


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1: Participants with newly and previously diagnosed stable disease<br> | Other: Prospective observational cohort study<br>* Prospective observational cohort study<br>|
| Cohort 2: Participants with moderate acute exacerbation not requiring hospitalization<br> | Other: Prospective observational cohort study<br>* Prospective observational cohort study<br>|
| Cohort 3: Participants requiring hospitalization for an acute exacerbation<br> | Other: Prospective observational cohort study<br>* Prospective observational cohort study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants by each COPD maintenance treatment |  | Up to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants with disease severity and socio-economic factors by each COPD maintenance treatment |  | Baseline (Day 1) | 
| Percentage of participants whose prescribed maintenance treatment is stepped up (adding another maintenance treatment), stepped down (withdraw any of, switched, stopped (stop all maintenance treatment) or remained the same |  | Up to 3 months | 
| Percentage of participants by their Modified British Medical Research Council (mMRC) score at Baseline |  | Baseline (Day 1) | 
| Percentage of participants by their COPD assessment test (CAT) score |  | Up to 3 months | 
| Number of participants with history of exacerbations within 1 year prior to Baseline visit |  | Within 1 year prior to Baseline visit (Day 1) | 
| Percentage of participants receiving each treatment class at 3 months |  | At 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Disease burden, Chronic obstructive pulmonary disease, China, Maintenance treatment patterns