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NCT05852327 Clinical Trial

Risk Stratifying COPD Exacerbations

COPD Exacerbation Clinical Trial

— ProECOPD_23  

Official title:
Risk Stratifying COPD Exacerbations: a Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05852327
Other study ID # ProECOPD_23
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 1, 2023
Est. completion date February 1, 2025

Study information
Verified date December 2023
Source Pamela Youde Nethersole Eastern Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date February 1, 2025
Est. primary completion date February 1, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Observation only
Observation only

Locations
Country Name City State
Hong Kong Charles Wong Hong Kong Other
Hong Kong Pamela Youde Nethersole Eastern Hospital Hong Kong

Sponsors (1)
Lead Sponsor Collaborator
Pamela Youde Nethersole Eastern Hospital

Country where clinical trial is conducted

Hong Kong, 

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