A Real-World Prospective Observational Study to Describe the Safety Profile and Clinical Outcomes of Budesonide/Glycopyrrolate/Formoterol Fumarate (BGF) In Chinese Patients with Chronic Obstructive Pulmonary Disease (COPD).

OBJECTIVES

This observational, multicenter, prospective, single-arm study (NCT04536402) aimed to describe the safety profile and clinical outcomes of Budesonide/Glycopyrrolate/Formoterol Fumarate metered dose inhaler (BGF MDI) for Chinese patients with COPD in clinical practice.

METHODS

COPD patients who had been prescribed and had planned to take at least one inhalation of BGF MDI were followed-up for 12 weeks at 4-week intervals. The primary endpoints were incidences of adverse events (AEs) and serious adverse events (SAEs). Secondary endpoints included changes from baseline in COPD Assessment Test (CAT) score and St George's Respiratory Questionnaire (SGRQ) score and patient global impression of change (PGIC) scale at week 4. Patients were also stratified into subgroups according to the asthma history, exacerbation history, and baseline treatment and assessed.

RESULTS

Of the enrolled 3,317 patients, 2,137 completed and 1,180 discontinued the study. No unexpected safety signals were observed; most AEs were mild (13.2%) or moderate (7.2%). SAEs occurred in 4.9% of patients. BGF MDI was associated with decreased CAT and SGRQ total scores (mean [SD] changes from baseline: -6.7 [7.27], -14.5 [18.19]) and increased FEV1 (189 mL, n = 241) at week 12. Similar trend of improvement was also observed in the subgroups. At week 4, 84.8% rated overall PGIC status as "improved," and 87.6% were satisfied with the MDI device.

CONCLUSION

In real-world practice, BGF MDI demonstrated good tolerability consistent with previous RCTs, and associated with a trend toward improvement in patients' symptoms, quality of life, and lung function, regardless of asthma history, exacerbation history, or baseline treatment.

TRIAL REGISTRATION: NCT04536402 (ClinicalTrials.gov), registered on 28 August 2020.