Risk Stratifying COPD Exacerbations | NCT05852327

Studies
Risk Stratifying COPD Exacerbations

NCT05852327

Sponsor

Pamela Youde Nethersole Eastern Hospital

Status

Unknown status

Last Update Posted

Dec 27, 2023Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

COPD Exacerbation

Interventions

Observation only

Countries

Hong Kong

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2023Actual

Primary Completion Date

Feb 1, 2024Estimated

Completion Date

Feb 1, 2025Estimated

First Submitted Date

May 1, 2023

First Submission Date that Met QC Criteria

May 1, 2023

First Posted Date

May 10, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 23, 2023

Last Update Posted Date

Dec 27, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Wong Charles, Associate Consultant, Department of Medicine, Pamela Youde Nethersole Eastern HospitalPrincipal Investigator

Lead Sponsor

Pamela Youde Nethersole Eastern HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
COPD		Subjects with COPD exacerbation	Other: Observation only

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Observation only	Other	Observation only	COPD

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

500 subjects with COPD exacerbation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Charles Wong	Recruiting	Hong Kong	Other		Hong Kong

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided