Acute Exacerbation of Chronic Obstructive Pulmonary Disease Inpatient Registry Study

Chronic Obstructive Pulmonary Disease Clinical Trial

— AECOPD-IRS  

Official title:

Acute Exacerbation of Chronic Obstructive Pulmonary Disease Inpatient Registry Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02657525
• Other study ID #: 2015-88
• Status: Active, not recruiting
• Phase: N/A
• First received: January 14, 2016
• Last updated: February 3, 2016
• Start date: January 2016
• Est. completion date: January 2020

Study information

• Verified date: February 2016
• Source: China-Japan Friendship Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The purpose of this study is to investigate the demographic characteristics, clinical features, diagnoses and treatments of AECOPD hospitalized patients in China, and disease prognosis and its economic burden.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 7600
• Est. completion date: January 2020
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

=18 years of age; hospitalized patients with main diagnosis as AECOPD.

Exclusion Criteria:

Patients diagnosed as active pulmonary tuberculosis, or acute left heart failure; Patients participating in clinical trials or intervention studies of drugs.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
China-Japan Friendship Hospital	China Soong Ching Ling Foundation, Peking University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-hospital mortality	All-cause and cause-specific mortality will be described.	12 months	No
Primary	Readmission	Readmission rate caused by AECOPD within 1 month after discharged from hospital.	12 months	No
Secondary	All-cause and cause-specific mortality	All-cause and cause-specific mortality will be described at different time points (1, 2, 3 years)	3 years	No
Secondary	Recurrence of acute exacerbation of COPD	Frequency of AECOPD recurrence will be described during follow-ups, the date of first recurrence after discharge will be analysed.	3 years	No
Secondary	Lung function and quality of life assessment	Lung function will be measured regularly, quality of life will be assessed by questionnaires	3 years	No
Secondary	Healthcare costs	Direct costs of hospital stay will be recorded.	12 months	No