Real-world safety of budesonide/glycopyrrolate/formoterol in Chinese patients with chronic obstructive pulmonary disease

<bold>Background:</bold> Budesonide/glycopyrronium/formoterol (BGF) is a triple therapy delivered in a metered dose inhaler (MDI) for chronic obstructive pulmonary disease (COPD), this was the first real-world study evaluating the safety and effectiveness of BGF in Chinese COPD patients. <bold>Methods:</bold> In this multi-centre, prospective, observational, single-arm study (<ext-link>NCT04536402</ext-link>), Chinese COPD patients prescribed with BGF MDI were followed up for 12 weeks. Here we report the primary safety endpoints of incidences of adverse events (AEs) and serious AEs (SAEs), and secondary endpoint Aerosphere Delivery Technology (ADT) MDI preference questionnaire (AMPQ). <bold>Results:</bold> In the full analysis set (n=3317, 82.9% male, 96.2% ≥50 years old), during the study, AEs occurred in 793 (23.9%) patients and SAEs in 164 (4.9%) patients. Most AEs were mild (13.2%) or moderate (7.2%). The most common AEs were pneumonia (1.8%), hypokalaemia (1.6%), and upper respiratory tract infection and dysphonia (1.4% each). Pneumonia and bronchitis, which are considered as lower respiratory tract infections, totally occurred in 82 (2.5%) patients. Adverse drug reactions (ADRs) were reported in 141 (4.3%) patients, but serious ADRs (SADRs) in only 2 (0.1%) patients. The most common ADR was dysphonia (1.2%). At Week 4, among 2679 (80.8%) patients with AMPQ assessed, 2488 (92.8%) strongly agreed or agreed that the device was easy to use, and 2347 (87.6%) strongly agreed or agreed that they were satisfied with the device overall. Mean AMPQ total score was 20.6 (full score 25). <bold>Conclusions:</bold> BGF MDI was safe and well-tolerated in real-world clinical practice and most patients were satisfied with the device.