Effects of one year treatment with extrafine fixed triple inhaled therapy in moderate COPD in a real-life setting – results of the RATIONALE study

<bold>Introduction:</bold> Single inhaler triple therapy (SITT) is still considered as a last resort for patients with severe airflow limitation in many countries. Also there is a lack of evidence of efficacy from randomized controlled trials in patients who received open triple combinations. A non-interventional, prospective study was conducted to assess the efficacy of extrafine beclomethasone (BDP), formoterol (FF), glycopyrronium (GB) SITT in symptomatic, moderate COPD patients. <bold>Methods:</bold> RATIONALE is a 52-week, non-interventional, multicentre, prospective study evaluating the efficacy of beclomethasone/formoterol/glycopyrronium SITT in patients with moderate COPD. Main eligibility criteria were age ≥35 years, 50%≤FEV1≤80%, COPD Assessment Test (CAT) score≥10 or modified Medical Research Council score (mMRC)≥2 and ≥2 moderate/severe exacerbations/years. <bold>Results:</bold> 928 patients were included in this study. 648 patients (69.82%) received dual therapy (LABA-LAMA or ICS-LABA) and 280 patients (30.18%) open triple combination before enrollment. The average mMRC scores decreased significantly (p<0.0001). The mean values in the CAT and VAS scores improved significantly(p<0.0001). The proportion of patients not reporting any limitations in all EQ-5D-3L domains (p<0.0001) and the proportion of patients not reporting cough/sputum production also improved significantly (p<0.0001). <bold>Conclusions:</bold> Significant improvements were seen in all of the assessed parameters, showing a clear benefit for extrafine SITT in moderate COPD patients who were symptomatic on previous dual or open triple therapy.