Exacerbations and Their Outcomes International (EXACOS International)

NCT05750810 | Completed

• 1 other identifier: ESR-21-21659
• Study Type: observational
• Target: 3,477
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to quantify the burden of severe AECOPD in South Korea, by investigating the association between frequency of severe AECOPD and clinical and health-care utilization outcomes.

Conditions

COPD; Exacerbation Copd

Outcome Measures

Primary Outcomes (4)

• the frequency of severe AECOPD

  To estimate the frequency of severe AECOPD, in a COPD population

  10-year

• time trends in the frequency of severe exacerbations

  To describe any time trends in the frequency of severe exacerbations throughout the study period (over a 2-year period)

  2-year

• lung function decline over time

  To describe lung function decline over time (FEV1)

  3-year

• health care resource utilization

  To quantify health care resource utilization by number of severe AECOPD over a 2-year period

  2-year

Interventions

Severe exacerbation frequency OTHER

A severe exacerbation will be primarily defined as a hospitalization (with or without ICU) or an emergency department visit as a result of worsening of COPD symptoms.

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study was based on the Korea COPD Subgroup Study (KOCOSS) database, constructed from a nationwide prospective cohort study-initiated in April 2012-that involved 54 medical centers in South Korea. It was designed to evaluate characteristics of COPD patients in South Korea.

You may qualify if:

• Over 40 years old South Korean COPD patients(Bronchodilator test results FEV1/FVC \<0.7)
• COPD patients who complain of cough, sputum, dyspnea
• Unrelated smoking history

You may not qualify if:

• other disease like asthma patients which is similar to COPD symptoms.
• patients who is not suitable for pulmonary function test and communication
• myocardial infarction or cerebrovascular event within the previous 3 months
• pregnants
• patients who disagree with registration
• rheumatoid patients
• cancer patients(including metastatic cancer, leukemia, lymphoma)
• irritable bowel syndrome
• patients who use systemic steroids over 8 weeks due to other diseases except COPD

Sponsors & Collaborators

• Joon Young Choi: lead
• Seoul St. Mary's Hospital: collaborator
• Hallym University Medical Center: collaborator
• Konkuk University Hospital: collaborator

Study Sites (1)

Incheon St. Mary's Hospital

Incheon, Gyeongki, 21431, South Korea

Location

Related Publications (1)

• Rhee CK, Choi JY, Park YB, Yoo KH. Clinical Characteristics and Frequency of Chronic Obstructive Pulmonary Disease Exacerbations in Korean Patients: Findings From the KOCOSS Cohort 2012-2021. J Korean Med Sci. 2024 May 20;39(19):e164. doi: 10.3346/jkms.2024.39.e164.

  PMID: 38769923 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical assistant professor

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: March 2, 2023
• Study Start: April 1, 2012
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: March 2, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)