NCT05852327

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 1, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 10, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

December 27, 2023

Status Verified

December 1, 2023

Enrollment Period

1 year

First QC Date

May 1, 2023

Last Update Submit

December 23, 2023

Conditions

COPD Exacerbation

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (1)

COPD

Subjects with COPD exacerbation

Other: Observation only

Interventions

Observation onlyOTHER

Observation only

COPD

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

500 subjects with COPD exacerbation

You may qualify if:

  • 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

You may not qualify if:

  • Age \< 18 years old
  • No informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Charles Wong

Hong Kong, Other, Hong Kong

RECRUITING

Pamela Youde Nethersole Eastern Hospital

Hong Kong, Hong Kong

RECRUITING

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Consultant, Department of Medicine

Study Record Dates

First Submitted

May 1, 2023

First Posted

May 10, 2023

Study Start

February 1, 2023

Primary Completion

February 1, 2024

Study Completion

February 1, 2025

Last Updated

December 27, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

HK(2)