Clinical trial NCT05032898: Acute Exacerbation of Chronic Obstructive Pulmonary Disease Inpatient Registry Study Stage II
Official title: Acute Exacerbation of Chronic Obstructive Pulmonary Disease Inpatient Registry Study Stage II
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: registries
demography
therapeutics
disease management
mortality
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2021-09-02
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients hospitalized with acute exacerbation of chronic obstructive pulmonary disease will be consecutively recruited from target hospitals.

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.

Eligibility criteria: 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

Primary outcomes:
measure: All-cause in-hospital mortality
timeFrame: From date of admission to date of discharge, an expected median of 10 days
measure: Incidence of readmission due to acute exacerbation of chronic obstructive pulmonary disease within 30 days after discharge
timeFrame: 30 days after day of discharge
Secondary outcomes:
measure: All-cause mortality
timeFrame: 30 days and 1 year after day of discharge
measure: Incidence of readmission due to acute exacerbation of chronic obstructive pulmonary disease within 1 year after discharge
timeFrame: 1 year after day of discharge
measure: Time to the first readmission due to acute exacerbation of chronic obstructive pulmonary disease
timeFrame: 30 days, 1 year after day of discharge
measure: Post-bronchodilator forced expiratory volume in one second (L)
timeFrame: 30 days, 1 year after day of discharge
measure: Predicted post-bronchodilator forced expiratory volume in one second (%)
timeFrame: 30 days, 1 year after day of discharge
measure: Post-bronchodilator forced vital capacity (L)
timeFrame: 30 days, 1 year after day of discharge
measure: Post-bronchodilator forced expiratory volume in one second to forced vital capacity
timeFrame: 30 days, 1 year after day of discharge
measure: Chronic obstructive pulmonary disease assessment test (CAT) score
timeFrame: At day of discharge (an expected median of 10 days), 30 days, 1 year after day of discharge
measure: Modified medical research council (mMRC) dyspnea scale
timeFrame: At day of discharge (an expected median of 10 days), 30 days, 1 year after day of discharge
measure: Direct total cost of chronic obstructive pulmonary disease management
timeFrame: At day of discharge (an expected median of 10 days), 30 days, 1 year after day of discharge
Other outcomes:
Locations:
Study officials:
affiliation: Institue of Basic Medical Sciences Chinese Academy of Medical Sciences
name: Chen Wang, Doctor
role: STUDY_CHAIR
affiliation: China-Japan Friendship Hospital
name: Ting Yang, Doctor
role: PRINCIPAL_INVESTIGATOR
References: