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

• Conditions: Pulmonary Disease, Chronic Obstructive

• Registration Number: NCT05032898
• Lead Sponsor: China-Japan Friendship Hospital

Brief Summary

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

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.

Study Timeline

• Status Verified: 2021-08
• Study First Submitted: 2021-08-27
• Study First Submitted QC: 2021-08-27
• Last Update Submitted: 2021-08-27
• Study Start: 2021-09
• Study First Posted: 2021-09-02
• Last Update Posted: 2021-09-02
• Primary Completion: 2022-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Time to the first readmission due to acute exacerbation of chronic obstructive pulmonary disease	30 days, 1 year after day of discharge	Time to the first readmission due to acute exacerbation of chronic obstructive pulmonary disease (AECOPD) during follow-ups
Incidence of readmission due to acute exacerbation of chronic obstructive pulmonary disease within 1 year after discharge	1 year after day of discharge	Incidence of readmission due to acute exacerbation of chronic obstructive pulmonary disease (AECOPD) within 1 year after discharge
Post-bronchodilator forced vital capacity (L)	30 days, 1 year after day of discharge	Post-bronchodilator forced vital capacity (L) during follow-ups
Chronic obstructive pulmonary disease assessment test (CAT) score	At day of discharge (an expected median of 10 days), 30 days, 1 year after day of discharge	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.
Modified medical research council (mMRC) dyspnea scale	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 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.
Post-bronchodilator forced expiratory volume in one second (L)	30 days, 1 year after day of discharge	Post-bronchodilator forced expiratory volume in one second (L) during follow-ups
Predicted post-bronchodilator forced expiratory volume in one second (%)	30 days, 1 year after day of discharge	Predicted post-bronchodilator forced expiratory volume in one second (%) during follow-ups
Post-bronchodilator forced expiratory volume in one second to forced vital capacity	30 days, 1 year after day of discharge	Post-bronchodilator forced expiratory volume in one second to forced vital capacity during follow-ups
All-cause mortality	30 days and 1 year after day of discharge	All-cause mortality during follow-ups
Direct total cost of chronic obstructive pulmonary disease management	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 during hospitalization and follow-ups.