Symptoms improvement and lung function benefits of fixed triple therapy with beclomethasone/formoterol/glycopyrronium inhalation powder in patients with moderate-to-severe COPD: outcomes of the Bulgarian arm of the RESPONSE study.

BACKGROUND

The fixed triple beclomethasone dipropionate/formoterol fumarate/glycopyrronium (BDP/FF/GB) therapy is available in both pressurized metered-dose inhaler (pMDI) and dry powder inhaler (DPI) formulations for chronic obstructive pulmonary disease (COPD) treatment. While the pMDI form has been extensively investigated in pivotal trials and real-world studies, real-world data on the DPI (88/5/9 μg) formulation remain limited. The RESPONSE study assessed the real-world effectiveness of BDP/FF/GB inhalation powder in a cohort of moderate-to-severe COPD patients uncontrolled with dual combinations.

METHODS

This non-interventional, prospective, multicenter study was conducted across 21 Bulgarian sites. COPD patients (≥35 years) with persistent symptoms [COPD Assessment Tool (CAT) ≥10 and/or modified Medical Research Council (mMRC) ≥2] and moderate or severe pulmonary obstruction [30%≤ forced expiratory volume in 1 second as a percentage of predicted value (FEV1%) <80%] despite dual therapies were switched to BDP/FF/GB DPI and followed for 6 months. The primary endpoint was improvement in CAT scores. Secondary endpoints included lung function, treatment adherence, dyspnea and the percentage of patients achieving CAT score reduction ≥2 from baseline.

RESULTS

A total of 363 patients completed the study. Mean CAT scores improved significantly from 23.0 at baseline to 16.9 (P<0.001), regardless of prior dual therapy or inhaler type. Mean (± SD) FEV1% increased from 47.6%±11.9% to 53.2%±15.75% (P<0.001). Treatment adherence and dyspnea also showed significant improvement. Notably, 87.9% of participants achieved a CAT score reduction ≥2 points.

CONCLUSIONS

The RESPONSE study showed that switching to BDP/FF/GB DPI was associated with clinically meaningful improvements in symptoms, lung function, and adherence in COPD patients inadequately controlled on dual therapy, supporting its role as a practical escalation option in routine care.