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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pulmonary Disease, Chronic Obstructive

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 Type: Observational
• Enrollment (Anticipated): 1500

Contacts and Locations

• Study Contact: Name: Chen Wang, Doctor; Email: cyh-birm@263.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients hospitalized with acute exacerbation of chronic obstructive pulmonary disease will be consecutively recruited from target hospitals.

Description

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 Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: China-Japan Friendship Hospital
• Investigators: Study Chair: Chen Wang, Doctor, Institue of Basic Medical Sciences Chinese Academy of Medical Sciences; Principal Investigator: Ting Yang, Doctor, China-Japan Friendship Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2021
• Primary Completion (ANTICIPATED): December 1, 2022
• Study Completion (ANTICIPATED): December 1, 2023

Study Registration Dates

• First Submitted: August 27, 2021
• First Submitted That Met QC Criteria: August 27, 2021
• First Posted (ACTUAL): September 2, 2021

Study Record Updates

• Last Update Posted (ACTUAL): September 2, 2021
• Last Update Submitted That Met QC Criteria: August 27, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: mortality; therapeutics; disease management; registries; demography
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: AECOPD-IRS-II

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data that underlie the results (text, tables, figures, and appendices) reported in the publication of summary data, study protocol, statistical analysis plan (SAP), analytic code will be shared from 1 to 3 years following the completion of data cleaning. All above could be shared with researches who provide a methodologically sound and feasible proposal approved by principal investigator (email address: cyh-birm@263.net, dryangting@qq.com) and a signed data access agreement.
• IPD Sharing Time Frame: From 1 to 3 years following the completion of data cleaning.
• IPD Sharing Access Criteria: Researches should send a proposal to cyh-birm@263.net or dryangting@qq.com. If the proposal is methodologically sound, feasible and approved by the principal investigator, data requestor could gain access after signing a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No