COPD ExacerbationProECOPD_23NCT05852327
Risk Stratifying COPD Exacerbations
An observational study of COPD Exacerbation, run by Pamela Youde Nethersole Eastern Hospital at 2 sites in Hong Kong.
Trial summary
To identify clinical characteristics on presentation which predict differential outcomes in patients with exacerbation of COPD. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- COPD Exacerbation
- What is being tested?
- Observation only
- How many people
- 500 participants
- Where
- 2 sitesHong Kong
- Study dates
- 1 Feb 2023to 1 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Adult, Older adult
Study population: 500 subjects with COPD exacerbation
Who may be able to join
- 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
Who cannot join
- Age < 18 years old
- No informed consent
Trial locations and contacts
2 sites in 1 country.
Hong Kong2 sites, 2 recruiting
- Recruiting
Charles Wong
Hong Kong, Other
Charles Wong, MBChB, 25956111, wc679@ha.org.hk
- Recruiting
Pamela Youde Nethersole Eastern Hospital
Hong Kong
Charles Wong, MBChB, 25956111, wc679@ha.org.hk
About this study
Official title: Risk Stratifying COPD Exacerbations: a Prospective Study
To identify clinical characteristics on presentation which predict differential outcomes in patients with exacerbation of COPD.
Read the 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.
- Conditions
- COPD Exacerbation
- Being tested
- Observation only
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation onlyOther
Observation only
| Study group | Role | What they receive |
|---|---|---|
| COPD | Subjects with COPD exacerbation Receives: Other: Observation only |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital mortality
Number of patients died during hospitalization of ECOPD
Measured: 3-month
3-month mortality
Number of patients died 3 months after ECOPD
Measured: 3-month
Recurrent ECOPD
Number of patients with recurrent ECOPD post-discharge
Measured: 3-month
Viral etiology
Frequency of various viral etiology identified during ECOPD
Measured: 3-month
Bacterial etiology
Frequency of various bacterial etiology identified during ECOPD
Measured: 3-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start1 Feb 2023
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD ExacerbationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pamela Youde Nethersole Eastern Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wong Charles, Pamela Youde Nethersole Eastern Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05852327
- Sponsor's protocol ID
- ProECOPD_23
- Acronym
- ProECOPD_23
- Status last verified
- Dec 2023
- First submitted
- 1 May 2023
- Last updated
- 27 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Stratifying COPD Exacerbations: a Prospective Study
- ClinicalTrials.gov ID
- NCT05852327
- Acronym / sponsor ID
- ProECOPD_23 / ProECOPD_23
- Conditions
- COPD Exacerbation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Pamela Youde Nethersole Eastern HospitalUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 10 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD | – | Other: Observation onlySubjects with COPD exacerbation |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 500 subjects with COPD exacerbation
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Age < 18 years old
- No informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observation onlyObservation only | Other | COPD |
Primary outcome
In-hospital mortality
Time frame: 3-month
Number of patients died during hospitalization of ECOPD
3-month mortality
Time frame: 3-month
Number of patients died 3 months after ECOPD
Recurrent ECOPD
Time frame: 3-month
Number of patients with recurrent ECOPD post-discharge
Viral etiology
Time frame: 3-month
Frequency of various viral etiology identified during ECOPD
Bacterial etiology
Time frame: 3-month
Frequency of various bacterial etiology identified during ECOPD
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for COPD Exacerbation
RecruitingPhase 2
Rademikibart IV for Acute Asthma and COPD Exacerbation
Asthma Acute, COPD Exacerbation Acute
RecruitingObservational study
Characteristics and Outcomes of Patients Admitted to ICU for a Severe Acute Exacerbation of COPD.
COPD Exacerbation, ICU
Recruiting
A Prospective Study of Cardiovascular Risk of Patients Admitted for Acute Exacerbation of COPD
COPD
Active, not recruitingObservational study
CareCOPD - COPD Home Monitoring Study
Chronic Obstructive Pulmonary Disease
Not yet recruitingPhase 4
Efficacy of Nebulized Long-Acting Bronchodilators (Formoterol and Revefenacin) vs. Short-Acting Bronchodilators (Albuterol and Ipratropium) in Patients Presenting to the Emergency Department With Acute Exacerbation of COPD (ECOPD)
COPD Exacerbation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD Exacerbation, run by Pamela Youde Nethersole Eastern Hospital at 2 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital mortality (time frame: 3-month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2023.