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%≤ FEV₁%< 80%) despite dual therapies were switched to BDP/FF/GB DPI and followed for six 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.