Impact of dry powder Beclometasone/Formoterol/Glycopyrronium Extrafine Single Inhaler Triple Therapy (efSITT) in patients with Chronic Obstructive Pulmonary Disease (COPD): TriNEXT Study

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Introduction: EfSITT has shown reduced symptoms and improved Health-Related Quality of Life (HRQoL) in COPD patients. While substantial data exists on pressurized metered-dose inhalers, real-world effectiveness (RWE) for DPI remains limited. Objectives: To assess improvement in HRQoL in COPD patients treated with dry powder BDP/FF/G efSITT in NEXThaler® device. Methods: A non-interventional prospective study in France, Spain and Italy, assessed DPI efSITT improvement in patients using CAT (QoL), VQ11 (QoL), D-12 (dyspnea), TAI (adherence) and connected watch over 6 months with visits at inclusion (D0), M3 and M6. This interim analysis focused on French patients at D0 and M3. Results: Of the 115 enrolled patients (mean age 67.6±7.5 years; 55% male; 27.8% with cardiovascular disease; 39.1% hypertension), 86.1% initiated DPI efSITT after dual therapy and 13.9% after free TT. At D0, patients had moderate (54,8%), severe (40%) and very severe (5,2%) air flow limitation and COPD was classified as GOLD B (64.4%) and as GOLD E (35.6%). Moderate/severe exacerbations occurred in 62.5% of them in the prior 12 months. CAT scores improved from 19.9± 6.7 (D0) to 16.9±7.4 (M3), with a mean change of-3.5± 6.8 (95%CI: -5.4, -1.6). Mean changes in VQ11 and D-12 were -2.8±9.6 (-5.4, -0.2) (D0: 28.4±9.2; M3: 26.1±9.7) and -6.7±8.4 (-9, -4.5) (D0: 16.9±9.3; M3: 10.8±8.5). Adherence to efSITT was good in 55.6% of patients (TAI). Conclusions: Statistically and clinically relevant improvement of respiratory symptoms and HRQoL was observed at M3. Most patients of the study stepped up from dual therapy to DPI efSITT.

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