Beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium bromide (BDP/F/GB) 87/5/9 µg via pMDI is also approved in the European Union. In the United States and the European Union, approved treatments for COPD include budesonide/glycopyrronium/formoterol fumarate dihydrate (BGF) 320/14.4/10 µg via pressurized metered dose inhaler (pMDI) and fluticasone furoate/umeclidinium/vilanterol (FF/UM/VI) 100/62.5/25 µg via dry powder inhaler (DPI). Multiple single-inhaler inhaled corticosteroid/long-acting muscarinic antagonist/long-acting β 2-agonist (ICS/LAMA/LABA) therapies are approved for COPD maintenance treatment. Small airways disease plays a key role in chronic obstructive pulmonary disease (COPD) and is a major cause of airway obstruction therefore, it is a critical target of pharmacotherapy. Further research is needed to understand if the enhanced delivery of BGF translates to clinical benefits. Importantly, using an identical inhalation profile, there was an approximately five-fold difference in small airways deposition for the ICS components, with only a small percentage of the ICS from FF/UM/VI reaching the small airways. ConclusionsīGF was associated with greater total, central, and small airways deposition for all components versus FF/UM/VI. For the common profile, total, central, and regional small airways deposition were significantly greater for BGF versus FF/UM/VI (nominal p < 0.001), overall and for treatment components notably, regional small airways deposition of the ICS components was approximately five-fold greater with budesonide versus fluticasone furoate (16.1% vs. Mean regional small airways deposition was also greater across inhalation profiles with BGF (16.9–23.6%) versus FF/UM/VI (6.8–8.7%) and for each treatment component. ResultsĪcross inhalation profiles, mean total lung deposition was consistently higher with BGF (47.0–54.1%) versus FF/UM/VI (20.8–22.7%) and for each treatment component, with greater deposition for BGF also seen in the central large airways. For the common profile, deposition for BGF versus FF/UM/VI was compared post-hoc using paired t-tests. Simulations were performed using multiple inhalation profiles of varying durations and flow rates representing patterns suited for a pressurized metered-dose inhaler or dry-powder inhaler (four for BGF, two for FF/UM/VI, with one common profile). Total, central, and regional small airways deposition as a percentage of delivered dose of budesonide/glycopyrronium/formoterol fumarate dihydrate (BGF) 160/7.2/5 µg per actuation and fluticasone furoate/umeclidinium/vilanterol (FF/UM/VI) 100/62.5/25 µg were evaluated using in silico FRI based on in vitro aerodynamic particle size distributions of each device. Three-dimensional airway models were produced from 20 patients with moderate-to-very severe COPD. Deposition was assessed using real-world inhalation profiles simulating everyday use where optimal inhalation may be compromised. This study evaluated lung deposition of two inhaled corticosteroid (ICS)/long-acting β 2-agonist/long-acting muscarinic antagonist single-inhaler triple therapies using in silico functional respiratory imaging (FRI). Small airways disease plays a key role in the pathogenesis of chronic obstructive pulmonary disease (COPD) and is a major cause of obstruction therefore, it is a critical pharmacotherapy target.
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