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

PURPOSE: 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.

PATIENTS AND METHODS: 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.

RESULTS: 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.

CONCLUSION: 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).