Use, Effectiveness, and Safety of Inhaler Devices for LABA/LAMA Fixed-Dose Combinations in Patients with COPD

In Italy, long-acting bronchodilator (LABA/LAMA) fixed-dose combinations are widely used for treating chronic obstructive pulmonary disease (COPD). These medications are available in various inhaler devices, but clinical guidelines do not recommend a specific device, leaving the choice to clinicians...

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Main Authors: Sara Lopes, Maria Lucia Marino, Filomena Fortinguerra, Nera Agabiti, Valeria Belleudi, Francesco Trotta
Format: Article
Language:English
Published: Taylor & Francis Group 2025-05-01
Series:COPD
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Online Access:https://www.tandfonline.com/doi/10.1080/15412555.2025.2506548
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author Sara Lopes
Maria Lucia Marino
Filomena Fortinguerra
Nera Agabiti
Valeria Belleudi
Francesco Trotta
author_facet Sara Lopes
Maria Lucia Marino
Filomena Fortinguerra
Nera Agabiti
Valeria Belleudi
Francesco Trotta
author_sort Sara Lopes
collection DOAJ
description In Italy, long-acting bronchodilator (LABA/LAMA) fixed-dose combinations are widely used for treating chronic obstructive pulmonary disease (COPD). These medications are available in various inhaler devices, but clinical guidelines do not recommend a specific device, leaving the choice to clinicians based on patient needs. To date, no studies have directly compared the effectiveness and safety of different LABA/LAMA devices. This retrospective observational study evaluated the utilization, effectiveness, and safety of LABA/LAMA inhaler devices in COPD patients in the Lazio region, representing about 10% of Italy’s population. Patients aged 45 and older who initiated LABA/LAMA treatment between January 2017 and December 2019 were included. The devices analyzed were dry powder inhalers (DPI) capsule/strip (DPI-t, reference group), DPI with a reservoir (DPI-r), and soft mist inhalers (SMI). The study identified 12,346 eligible patients, with over 80% having prior COPD drug use. Of these, 53.2% used DPI-t, 19.7% DPI-r, and 27.1% SMI. No significant differences in severe exacerbations, mortality, pneumonia, or cerebro-cardiovascular events were observed among the devices. Hazard ratios for key outcomes (e.g., severe exacerbations, mortality) showed overlapping confidence intervals across device types, suggesting no device offered superior effectiveness or safety. This is the first study to assess LABA/LAMA device use in real-world clinical practice for COPD. Findings suggest therapeutic equivalence among devices, supporting flexibility in prescribing. Further research is needed to inform cost-effective prescribing policies for LABA/LAMA therapies.
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spelling doaj-art-cd98015a4a754746868f41ebfb3c40d52025-08-20T03:48:24ZengTaylor & Francis GroupCOPD1541-25551541-25632025-05-0122110.1080/15412555.2025.2506548Use, Effectiveness, and Safety of Inhaler Devices for LABA/LAMA Fixed-Dose Combinations in Patients with COPDSara Lopes0Maria Lucia Marino1Filomena Fortinguerra2Nera Agabiti3Valeria Belleudi4Francesco Trotta5Department of Epidemiology, Lazio Regional Health Service, Rome, ItalyItalian Medicines Agency, Rome, ItalyItalian Medicines Agency, Rome, ItalyDepartment of Epidemiology, Lazio Regional Health Service, Rome, ItalyDepartment of Epidemiology, Lazio Regional Health Service, Rome, ItalyItalian Medicines Agency, Rome, ItalyIn Italy, long-acting bronchodilator (LABA/LAMA) fixed-dose combinations are widely used for treating chronic obstructive pulmonary disease (COPD). These medications are available in various inhaler devices, but clinical guidelines do not recommend a specific device, leaving the choice to clinicians based on patient needs. To date, no studies have directly compared the effectiveness and safety of different LABA/LAMA devices. This retrospective observational study evaluated the utilization, effectiveness, and safety of LABA/LAMA inhaler devices in COPD patients in the Lazio region, representing about 10% of Italy’s population. Patients aged 45 and older who initiated LABA/LAMA treatment between January 2017 and December 2019 were included. The devices analyzed were dry powder inhalers (DPI) capsule/strip (DPI-t, reference group), DPI with a reservoir (DPI-r), and soft mist inhalers (SMI). The study identified 12,346 eligible patients, with over 80% having prior COPD drug use. Of these, 53.2% used DPI-t, 19.7% DPI-r, and 27.1% SMI. No significant differences in severe exacerbations, mortality, pneumonia, or cerebro-cardiovascular events were observed among the devices. Hazard ratios for key outcomes (e.g., severe exacerbations, mortality) showed overlapping confidence intervals across device types, suggesting no device offered superior effectiveness or safety. This is the first study to assess LABA/LAMA device use in real-world clinical practice for COPD. Findings suggest therapeutic equivalence among devices, supporting flexibility in prescribing. Further research is needed to inform cost-effective prescribing policies for LABA/LAMA therapies.https://www.tandfonline.com/doi/10.1080/15412555.2025.2506548Chronic obstructive pulmonary diseaseLABA/LAMAinhaler deviceuseeffectivenesssafety
spellingShingle Sara Lopes
Maria Lucia Marino
Filomena Fortinguerra
Nera Agabiti
Valeria Belleudi
Francesco Trotta
Use, Effectiveness, and Safety of Inhaler Devices for LABA/LAMA Fixed-Dose Combinations in Patients with COPD
COPD
Chronic obstructive pulmonary disease
LABA/LAMA
inhaler device
use
effectiveness
safety
title Use, Effectiveness, and Safety of Inhaler Devices for LABA/LAMA Fixed-Dose Combinations in Patients with COPD
title_full Use, Effectiveness, and Safety of Inhaler Devices for LABA/LAMA Fixed-Dose Combinations in Patients with COPD
title_fullStr Use, Effectiveness, and Safety of Inhaler Devices for LABA/LAMA Fixed-Dose Combinations in Patients with COPD
title_full_unstemmed Use, Effectiveness, and Safety of Inhaler Devices for LABA/LAMA Fixed-Dose Combinations in Patients with COPD
title_short Use, Effectiveness, and Safety of Inhaler Devices for LABA/LAMA Fixed-Dose Combinations in Patients with COPD
title_sort use effectiveness and safety of inhaler devices for laba lama fixed dose combinations in patients with copd
topic Chronic obstructive pulmonary disease
LABA/LAMA
inhaler device
use
effectiveness
safety
url https://www.tandfonline.com/doi/10.1080/15412555.2025.2506548
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