Risk Stratifying COPD Exacerbations (ProECOPD_23)

Risk Stratifying COPD Exacerbations: a Prospective Study

To identify clinical characteristics on presentation which predict differential outcomes in patients with exacerbation of COPD.

Study Overview

• Status: Recruiting
• Conditions: COPD Exacerbation
• Intervention / Treatment: Other: Observation only

Detailed Description

Exacerbations of COPD (ECOPD) are heterogenous but are often considered as a single clinical entity. Clinical characteristics on presentation may predict outcome of patients with ECOPD.

DECAF score was previously proposed to predict in-hospital mortality but has not been validated in Asian subjects. ROME classification was recently proposed to better risk stratify ECOPD according to symptoms, physiological parameters and laboratory findings on admission, but no prospective validation study is available so far.

This study aims to identify clinical characteristics on presentation to predict outcome of patients with ECOPD.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Pamela Youde Nethersole Eastern Hospital
    • Contact: Charles Wong, MBChB; Phone Number: 25956111; Email: wc679@ha.org.hk
  • Other
    • Hong Kong, Other, Hong Kong
      • Recruiting
      • Charles Wong
      • Contact: Charles Wong, MBChB; Phone Number: 25956111; Email: wc679@ha.org.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

500 subjects with COPD exacerbation

Description

Inclusion Criteria:

• Background history of COPD, defined by the GOLD 2023 guidelines
• Presented with exacerbation of COPD, defined by the GOLD 2023 guidelines
• Age >= 18 years old
• Informed consent available

Exclusion Criteria:

• Age < 18 years old
• No informed consent

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
COPD; Subjects with COPD exacerbation	Other: Observation only; Observation only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
In-hospital mortality	Number of patients died during hospitalization of ECOPD	3-month
3-month mortality	Number of patients died 3 months after ECOPD	3-month
Recurrent ECOPD	Number of patients with recurrent ECOPD post-discharge	3-month
Viral etiology	Frequency of various viral etiology identified during ECOPD	3-month
Bacterial etiology	Frequency of various bacterial etiology identified during ECOPD	3-month

Collaborators and Investigators

• Sponsor: Pamela Youde Nethersole Eastern Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: May 1, 2023
• First Submitted That Met QC Criteria: May 1, 2023
• First Posted (Actual): May 10, 2023

Study Record Updates

• Last Update Posted (Estimated): December 27, 2023
• Last Update Submitted That Met QC Criteria: December 23, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Lung Diseases, Obstructive; Chronic Disease; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: ProECOPD_23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No