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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05032898
• Other study ID #: AECOPD-IRS-II
• Status: Not yet recruiting
• Start date: September 2021
• Est. completion date: December 2023

Study information

• Verified date: August 2021
• Source: China-Japan Friendship Hospital
• Contact: Ting Yang, Doctor
• Phone: 13651380809
• Email: dryangting[@]qq.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1500
• Est. completion date: December 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
China-Japan Friendship Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause in-hospital mortality	All-cause mortality during hospitalization	From date of admission to date of discharge, an expected median of 10 days
Primary	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	All-cause mortality	All-cause mortality during follow-ups	30 days and 1 year after day of discharge
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Post-bronchodilator forced vital capacity (L)	Post-bronchodilator forced vital capacity (L) during follow-ups	30 days, 1 year after day of discharge
Secondary	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
Secondary	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
Secondary	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
Secondary	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