Acute Exacerbation of Chronic Obstructive Pulmonary Disease Inpatient Registry Study Stage II

Study Overview
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Brief Summary
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The aim of this study is to provide high quality data and give a comprehensive overview of characteristics, clinical features, management and prognosis during exacerbations and stable periods among inpatients with acute exacerbation of chronic obstructive pulmonary disease in real-world China.

Detailed Description
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Objective: The aim of this study is to provide high quality data and give a comprehensive overview of characteristics, clinical features, management and prognosis during exacerbations and stable periods among inpatients with acute exacerbation of chronic obstructive pulmonary disease in real-world China. Eligibility Criteria: Details are shown in the Eligibility Criteria part. Procedures and Measurements: At admission, each eligible subject will be given an in-depth interview to collect the demographics, smoking history, medical history, management of disease during stable period, etc. During hospitalization, treatment and auxiliary examination results including laboratory and lung function tests will be recorded if available. To ensure the quality and uniformity of spirometry data, training on performing spirometry will be provided to each study site by professional doctors from central site. At discharge, physicians will record the discharge diagnoses and clinical outcomes including death, intensive care unit admission, chronic obstructive pulmonary disease assessment test (CAT) score and total direct cost for each participant. During follow-ups, clinical outcomes including death and exacerbation events, change of medication, new-developed complications, auxiliary examination results, and economic burden will be collected.

Official Title
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Acute Exacerbation of Chronic Obstructive Pulmonary Disease Inpatient Registry Study Stage II

Conditions
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Pulmonary Disease, Chronic Obstructive

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥18 years of age hospitalized with main diagnosis of acute exacerbation of chronic obstructive pulmonary disease (AECOPD) Exclusion Criteria: refusing to sign informed consent forms participating in clinical trials or intervention studies of drugs diagnosed as active pulmonary tuberculosis, or acute left heart failure

Ages Eligible for Study
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Minimum Age: 18 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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause in-hospital mortality | All-cause mortality during hospitalization | From date of admission to date of discharge, an expected median of 10 days | 
| Incidence of readmission due to acute exacerbation of chronic obstructive pulmonary disease within 30 days after discharge | Incidence of readmission due to acute exacerbation of chronic obstructive pulmonary disease (AECOPD) within 30 days after discharge | 30 days after day of discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | All-cause mortality during follow-ups | 30 days and 1 year after day of discharge | 
| Incidence of readmission due to acute exacerbation of chronic obstructive pulmonary disease within 1 year after discharge | Incidence of readmission due to acute exacerbation of chronic obstructive pulmonary disease (AECOPD) within 1 year after discharge | 1 year after day of discharge | 
| Time to the first readmission due to acute exacerbation of chronic obstructive pulmonary disease | Time to the first readmission due to acute exacerbation of chronic obstructive pulmonary disease (AECOPD) during follow-ups | 30 days, 1 year after day of discharge | 
| Post-bronchodilator forced expiratory volume in one second (L) | Post-bronchodilator forced expiratory volume in one second (L) during follow-ups | 30 days, 1 year after day of discharge | 
| Predicted post-bronchodilator forced expiratory volume in one second (%) | Predicted post-bronchodilator forced expiratory volume in one second (%) during follow-ups | 30 days, 1 year after day of discharge | 
| Post-bronchodilator forced vital capacity (L) | Post-bronchodilator forced vital capacity (L) during follow-ups | 30 days, 1 year after day of discharge | 
| Post-bronchodilator forced expiratory volume in one second to forced vital capacity | Post-bronchodilator forced expiratory volume in one second to forced vital capacity during follow-ups | 30 days, 1 year after day of discharge | 
| Chronic obstructive pulmonary disease assessment test (CAT) score | Chronic obstructive pulmonary disease assessment test (CAT) score at day of discharge and during follow-ups. CAT is an 8-item questionnaire used to measure the impact of respiratory disease on patients' health status. The score of CAT ranges from 0 to 40, with 0 indicating the best health status while 40 as the worst. | At day of discharge (an expected median of 10 days), 30 days, 1 year after day of discharge | 
| Modified medical research council (mMRC) dyspnea scale | Modified medical research council (mMRC) dyspnea scale at day of discharge and during follow-ups. mMRC includes 5 grades (0, 1, 2, 3 and 4), where higher grade reflects worse health-related quality of life and higher symptom burden. | At day of discharge (an expected median of 10 days), 30 days, 1 year after day of discharge | 
| Direct total cost of chronic obstructive pulmonary disease management | Direct total cost of chronic obstructive pulmonary disease management during hospitalization and follow-ups. | At day of discharge (an expected median of 10 days), 30 days, 1 year after day of discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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registries, demography, therapeutics, disease management, mortality