BGF inhaler safe to use in COPD patients

Treatment with budesonide/glycopyrrolate/formoterol (BGF) using a metered dose inhaler (MDI) demonstrates an acceptable safety profile and improves symptoms in patients with chronic obstructive pulmonary disease (COPD) in a real-world clinical setting, results of the TORES study have shown. 

Eligible patients were recruited from 42 centres (tertiary hospitals) in China. They had a diagnosis of chronic obstructive pulmonary disease (COPD) and were prescribed to take at least one inhalation of BGF MDI based on physician’s decision. 

A total of 3,349 patients (mean age 67.2 years, 82.9 percent male) underwent screening, of whom 3,317 received at least one dose of BGF. Of these, 48.7 percent were at low risk of exacerbation, and 51.0 percent did not receive prior maintenance therapy. More than half of the patients (57.7 percent) had an eosinophil count of ≥100/mm3. 

Nearly one in four participants (n=793, 23.9 percent) experienced one or more adverse events (AEs), most of which were either mild (13.2 percent) or moderate (7.2 percent) in severity. The most common AEs reported were pneumonia (1.8 percent), hypokalemia (1.6 percent), upper respiratory tract infection (1.4 percent), and dysphonia (1.4 percent). 

Of note, 25 patients (0.8 percent) had at least one AE leading to death, but all were deemed unrelated to the study drug. 

In addition, 164 patients (4.9 percent) had at least one serious AE, of which the most frequently reported were pneumonia (0.4 percent) and lower respiratory tract infection (0.3 percent). Adverse drug reactions (ADR) also occurred in 141 patients (4.3 percent), with dysphonia (1.2 percent) being the most common. Serious ADRs, such as hypertension and hypertensive crisis, occurred in two patients (0.1 percent). 

In terms of efficacy, “BGF MDI is associated with notable improvements in symptoms and quality of life for patients with COPD,” said lead investigator Dr Yongchang Sun from Peking University Third Hospital, Beijing, China, who presented the findings at APSR 2024. 

At week 4, use of BGF MDI resulted in significant reductions in COPD Assessment Test (CAT) (‒4.6) and in St George’s Respiratory Questionnaire (SGRQ; ‒11.0) total scores. This trend persisted through 12 weeks.  

Majority of the patients achieved the minimum clinically important difference (MCID) in CAT (68.3 percent) and SGRQ scores (62.7 percent) at 4 weeks. The number of patients achieving MCID increased continuously over 12 weeks. 

BGF MDI also contributed to improved lung function in COPD patients. After treatment, the FEV1 increased by 234 mL at week 4, 291 mL at week 8, and 189 mL at week 12 compared with baseline. 

MDI device 

Most of the patients expressed satisfaction with the Aerosphere Delivery Technology MDI device. Specifically, 92.8 percent of participants said they could easily use the device, while 87.6 percent said they were satisfied with its use. 

In subgroup analysis, the improvements in symptoms and quality of life among patients treated with BGF MDI persisted over 12 weeks, regardless of smoking or asthma status. 

For patients with CAT score ≥10, BGF MDI resulted in significant improvements in CAT and SGRQ total scores, which were sustained through 12 weeks. The same trend was also observed regardless of airflow limitation severity, exacerbation history, and baseline treatment. 

“BGF via Aerosphere inhaler was well-established in patients with COPD in a real-world setting, and the majority of patients were satisfied with the co-suspension MDI device,” Sun said. 

“A numeric trend of greater improvement in symptoms and quality of life was observed in patients using BGF MDI as initial treatment or switching from oral drugs, which warrants further research,” he added.