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

NCT ID: NCT05032898

Last Updated: 2021-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-30

Study Completion Date

2023-12-31

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.

Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China-Japan Friendship Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chen Wang

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chen Wang, Doctor

Role: STUDY_CHAIR

Institue of Basic Medical Sciences Chinese Academy of Medical Sciences

Ting Yang, Doctor

Role: PRINCIPAL_INVESTIGATOR

China-Japan Friendship Hospital

Central Contacts

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Ting Yang, Doctor

Role: CONTACT

13651380809

Chen Wang, Doctor

Role: CONTACT

Other Identifiers

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AECOPD-IRS-II

Identifier Type: -

Identifier Source: org_study_id

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