Real-world efficacy of BDP/FF/G fixed triple inhalation powder (NEXThaler) therapy in the treatment of moderate to severe COPD patients (RESPONSE study).

Chronic obstructive pulmonary disease (COPD) remains a leading cause of morbidity and mortality worldwide, placing a significant burden on healthcare systems and patients' quality of life. The cornerstone of treatment includes fixed triple combinations of inhaled corticosteroids (ICS), long-acting β2-agonists (LABA), and long-acting muscarinic antagonists (LAMA) shown to improve lung function, reduce exacerbations, and enhance symptom control in patients with moderate to severe disease. However, there is still a lack of clinical evidence for the real-life effectiveness of fixed triple combinations. RESPONSE was a non-interventional, prospective, 26-week study, assessing the effectiveness of beclometasone/formoterol/glycopyrronium-bromide (BDP/FF/G) 88/5/9 μg administered via a dry powder inhaler (DPI), in symptomatic COPD patients, with moderate to severe airflow obstruction, previously treated with LABA-LAMA or ICS-LABA dual combinations. The study included 3 visits, where data on demographic and COPD-specific parameters, symptoms, quality of life (based on the EQ-5D-3L questionnaire), adherence (based on the TAI-12 questionnaire) and lung function were collected. The primary objective was the change of COPD Assessment Test (CAT) scores during the study, compared to baseline. Altogether, data of 1336 patients had been analysed. Their average age was 67 years and 50.3 % were female. The average CAT score was 20.4 and the average FEV1 was 52.3 %. Most patients had some limitation in one or more dimensions of EQ-5D-3L, with an average visual analogue scale score (VAS) of 59.1. After 6 months of treatment, there was a significant and clinically relevant improvement in average CAT score by 6.3 points (95 % CI: 6.0-6.7; p < 0.001) and average FEV1 by +120 mL (95 % CI: 100-140, p < 0.001). There was a significant improvement in all dimensions of EQ-5D-3L, with an average increase of 12.1 (95 % CI: 11.3-12.3, p < 0.001) points in the VAS score. The RESPONSE study is the first to evaluate the real-world effectiveness of the BDP/FF/G 88/5/9 μg DPI in patients with moderate to severe COPD. At the time of publication, this DPI formulation represents the only available extrafine particle-size fixed triple combination therapy for COPD. We demonstrated that BDP/FF/G DPI led to improvements in symptoms, quality of life, lung function, and even in adherence after patients were switched from dual therapy (LABA/LAMA or ICS/LABA).