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 type

Study topic

DiseaseĀ /health condition

Study type

Non-interventional study

Scope of the study

Effectiveness study (incl. comparative)
Safety study (incl. comparative)

Data collection methods

Secondary use of data
Population studied

Short description of the study population

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).
Study design details

Study design

An international, multicentre, retrospective database study

Main study objective

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.