Effects of triple pharmacological therapy on post-discharge outcomes in patients with COPD
Effects of triple pharmacological therapy on post-discharge outcomes in patients with COPD
EU PAS number: EUPAS1000000444
Study Status : Ongoing*
This is an international, multicentre, retrospective observational study that aims to:
- Determine the rate of hospital readmission for acute exacerbations of COPD (AECOPD) within one year after discharge.
- Assess the time to first exacerbation, readmission, or major adverse cardiovascular event (MACE) during this period.
- Examine how triple therapy (LAMA/LABA/ICS) prescribing changes before and after hospital discharge.
- Identify patients at highest risk of early readmission (within 30 days) and characterise those who remain exacerbation-free versus those with recurrent events despite therapy.
- Explore mortality and healthcare resource utilisation in the year following hospitalisation.
Rationale
Chronic Obstructive Pulmonary Disease (COPD) is the third leading cause of death worldwide, marked by progressive airflow obstruction and recurrent exacerbations that worsen outcomes and increase healthcare costs(1).
Triple therapy (LAMA/LABA/ICS) has been shown in clinical studies to improve lung function and reduce exacerbations. However, its real-world use remains inconsistent, partly due to concerns over side effects such as pneumonia. As a result, many patients may not be receiving the most appropriate therapy after hospitalisation(2).
Readmissions after AECOPD remain high — with up to one-third of patients re-hospitalised within three months — and are often linked with serious cardiovascular events. There is an urgent need to better understand how treatment decisions, particularly triple therapy, affect outcomes in everyday practice(3).
Statement of Need
Despite recommendations, the use of triple therapy after hospital discharge remains inconsistent. This variation appears linked to physicians’ attitudes toward triple therapy and to discharge protocols, which differ across centres and countries. A clearer understanding of these differences, and of the underlying causes of hospital readmissions, is essential.
There is an opportunity to improve COPD management through early identification of patients unlikely to benefit from triple therapy, who may instead require alternative strategies such as biologic therapy. This study aims to identify patients most at risk of readmission and to evaluate the risk/benefit ratio of triple therapy on an individual patient basis.
Study design
In this retrospective study, each participating site will be asked to extract data from their hospital records according to a standardised set of study variables defined by REG, under the supervision of the Principal Investigator and Steering Committee.
Each site will submit its own dataset, which will then be harmonised, validated, and combined with others to create a single comprehensive study dataset. This process ensures consistency across sites while capturing the diversity of real-world clinical practice in different healthcare systems.
- Enrolment period: 2018–2023 (based on discharge date for severe AECOPD). Each patient will be followed for one-year post-discharge, with final follow-up completed in 2024.
Study Population
We aim to include approximately 2,800 COPD patients across all participating centres. Eligible patients must have spirometry-defined COPD, be aged 40 years or older, have a smoking history of at least 10 pack-years, and have been hospitalised for severe AECOPD.
Patients will be excluded if they have a life expectancy shorter than 6 months, concomitant chronic respiratory conditions (e.g. fibrosis, tuberculosis), or severe co-morbidities likely to limit survival.
Participating study sites
This study currently involves 16 sites, representing a wide range of healthcare systems and clinical practices. Additional centres are actively being invited to join the study, and we welcome interest from new sites who wish to participate.
For further information or to express interest in becoming a participating site, please contact Dr Valeria Perugini (valeria@regresearchnetwork.org).
Principal Investigator
- Chin Kook Rhee
Study Steering Committee
- Marc Miravitlles
- Nicolas Roche
- Bernardino Alcazar Navarrete
- Miriam Barrecheguren
- Matevz Harlander
- Antonio Anzueto
- Therese Lapperre
Status
The study is ongoing. Additional sites are currently recruiting. If you would like further information please contact Valeria Perugini (valeria@regresearchnetwork.org).
Funding
The study is funded by an unrestricted grant from Chiesi Farmaceutici S.p.A.
References
- Miravitlles M, Ribera A., et al. Respir Res. 2017;18:67.
- Suissa S, Kessler R, et al. Eur Respir J. 2011;37(2):264-272.
- Chen S, Miravitlles M, et al. Int J Chron Obstruct Pulmon Dis. 2022;17:2187–2000.