The impact of stepping up treatment from LABA/LAMA to extrafine single inhaler triple therapy on exacerbations of Greek patients with Chronic Obstructive Pulmonary Disease: The IMPROVE study

OBJECTIVE: Extrafine single inhaler triple therapy (efSITT) with beclometasone dipropionate, formoterol fumarate, and glycopyrronium (BDP/FF/G 87/5/9 μg) has shown clinical benefits in Chronic Obstructive Pulmonary Disease (COPD) patients, including fewer exacerbations in randomized controlled trials. The IMPROVE study evaluated its real-world effectiveness in Greece in COPD patients previously treated with dual bronchodilation, focusing on exacerbations and other clinical outcomes. METHODS: This prospective, multicenter, observational study was conducted over 52 weeks. The 1103 eligible patients had moderate-to-severe COPD, an indication for treatment with efSITT, and were symptomatic despite receiving dual bronchodilation. The number of exacerbations, COPD Assessment Test (CAT) score, lung function parameters, use of rescue medication and adherence were recorded at baseline (visit 1), 6 months (visit 2), and 12 months (visit 3) after treatment. RESULTS: The percentage of patients with ≥1 exacerbation decreased from 100 % at visit 1 to 23.1% at visit 3 (p < 0.001). The mean CAT score decreased from 22.5 points at visit 1, to 16.6 at visit 2 and 14.2 at visit 3 (p < 0.001 for all pair comparisons). The mean TAI score increased from 44.6 points at visit 1, to 47.1 at visit 2 and 47.6 at visit 3. (p < 0.001 for V1/2 and V1/3 pairs, p = 0.024 for V2/3). Between visit 1 and visit 3, mean FEV1 increased from 1.6 L to 1.7 L (p < 0.001, n = 396). CONCLUSIONS: The IMPROVE findings indicate that extrafine BDP/FF/G improves clinical outcomes in symptomatic COPD patients previously treated with dual bronchodilation in a real-world setting in Greece.