ProECOPD_23: Risk Stratifying COPD Exacerbations

• Sponsor: Pamela Youde Nethersole Eastern Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05852327
• Collaborator: (none)
• Enrollment: 500
• Locations: 2
• Anticipated Duration (Months): 24
• Patients Per Site: 250
• Patients Per Site Per Month: 10.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
COPD Exacerbation	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 Design

• Study Type: Observational
• Anticipated Enrollment: 500 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Risk Stratifying COPD Exacerbations: a Prospective Study
• Actual Study Start Date: Feb 1, 2023
• Anticipated Primary Completion Date: Feb 1, 2024
• Anticipated Study Completion Date: Feb 1, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. In-hospital mortality [3-month]

   Number of patients died during hospitalization of ECOPD

2. 3-month mortality [3-month]

   Number of patients died 3 months after ECOPD

3. Recurrent ECOPD [3-month]

   Number of patients with recurrent ECOPD post-discharge

4. Viral etiology [3-month]

   Frequency of various viral etiology identified during ECOPD

5. Bacterial etiology [3-month]

   Frequency of various bacterial etiology identified during ECOPD

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Charles Wong	Hong Kong	Other	Hong Kong
2	Pamela Youde Nethersole Eastern Hospital	Hong Kong		Hong Kong

Sponsors and Collaborators

• Pamela Youde Nethersole Eastern Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wong Charles, Associate Consultant, Department of Medicine, Pamela Youde Nethersole Eastern Hospital
• ClinicalTrials.gov Identifier: NCT05852327
• Other Study ID Numbers: ProECOPD_23
• First Posted: May 10, 2023
• Last Update Posted: May 16, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pulmonary Disease, Chronic Obstructive

Study Results

No Results Posted as of May 16, 2023