Symptom Improvement with BDP/FF/G Fixed Triple Inhalation Powder in Moderate to Severe COPD Patients Uncontrolled with Dual Therapies: A Non-Interventional, Open-Label, Single-Arm, Prospective Study (RESPONSE Slovenia).

Abstract

People living with COPD are frequently inadequately treated due to underdiagnosis or misdiagnosis. The aim of this study was to evaluate the real-world performance of the beclomethasone dipropionate/formoterol fumarate/glycopyrronium (BDP/FF/G) fixed triple combination formulated in a dry powder inhaler (DPI) in improving symptoms, lung function, and adherence in moderate to severe COPD patients uncontrolled on dual therapies. We conducted a non-interventional, open-label, single-arm, multicenter, prospective study across 19 outpatient centers in Slovenia. The primary objective was to measure symptom improvement with the COPD Assessment Tool (CAT). A total of 359 patients with moderate to severe COPD (97% classified as GOLD E, frequent exacerbators) were followed for 24 weeks. There was a significant 6-point reduction in the CAT score after switching from dual therapies to BDP/FF/G inhalation powder (95% CI: -7.0 to -5.5; p < 0.0001). FEV₁ increased by 110 mL (95% CI: 90-130; p < 0.0001) and FVC by 95 mL (95% CI: 65-120; p < 0.0001), reaching a statistically significant improvement of 2.5 percentage points in the FEV₁/FVC quotient. The net improvement in dyspnea severity was 50.9% (95% CI 44.7%-57.2%), as assessed using the modified Medical Research Council (mMRC) Scale. Treatment adherence improved significantly after 6 months of triple therapy. In our cohort, switching uncontrolled moderate-to-severe COPD patients from dual therapy to BDP/FF/G fixed triple inhalation powder led to significant improvements in symptoms, lung function, dyspnea, sleep quality, and treatment adherence.