Effects of triple pharmacological therapy on post-discharge outcomes in patients with COPD

25/09/2025
02/09/2026
EU PAS number:
EUPAS1000000444
Study
Planned
Study summary
No information provided.
Study identification

EU PAS number

EUPAS1000000444

Study ID

1000000444

Official title and acronym

Effects of triple pharmacological therapy on post-discharge outcomes in patients with COPD

DARWIN EU® study

No

Study countries

Belgium
France
Korea, Republic of
Malta
Poland
Singapore
Spain

Study description

This is an international, multicentre, retrospective database study designed to identify patients at the highest risk of hospital readmission, with a specific focus on evaluating the risk/benefit ratio of triple therapy on an individual basis. By addressing these objectives, the study aims to contribute to the development of targeted strategies for improving patient outcomes and optimising resource utilisation.

The study will utilise anonymised, research-quality data extracted from electronic medical records (EMRs) within hospital databases across multiple countries.

It spans a five-year period, from January 1, 2018, to December 31, 2022, with the following key components:
Enrollment Period -> January 1, 2018, to December 21, 2021 (based on the date of discharge following a severe exacerbation).
Follow-Up Period -> One year after the date of discharge.

Inclusion Criteria:
Spirometry-confirmed COPD diagnosis (post-bronchodilator FEV1/FVC <0.7 within one year before enrollment).
Age 40 years.
Smoking history of 10 pack-years.
Recent discharge from the hospital due to a severe exacerbation.
Patients receiving any therapy (mono-, duo-, triple therapy, or no therapy).

Exclusion Criteria:
Life expectancy shorter than six months.
Presence of concomitant chronic respiratory conditions, such as current asthma, severe bronchiectasis, cystic fibrosis, lung fibrosis, or active tuberculosis.
Severe comorbidities likely to limit survival to less than six months (e.g., active neoplasm or severe cardiac insufficiency).

This study has the potential to significantly improve clinical management for COPD patients by identifying those at high risk of hospital readmission and evaluating the individualised risk/benefit ratio of triple therapy. Additionally, it will enhance understanding of factors influencing readmissions and guide targeted interventions, ultimately improving patient outcomes and optimising healthcare resource utilisation.

Study status

Planned
Research institutions and networks

Institutions

Respiratory Effectiveness Group (REG)

Contact details

Chin Kook Rhee

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:

Study start date

Planned:

Data analysis start date

Planned:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable