Evaluating asthma control in patients using Budesonide/Formoterol FDC as maintenance treatment, with or without reliever, in Greece. Results from the NOTOS study.

<bold>Background & Aim:</bold> Adjustments to asthma treatment are made based on patients’ symptom control and risk assessment¹. The NOTOS study assessed asthma control in Greek patients treated with the fixed dose combination (FDC) of budesonide/formoterol (BUD/FOR) via Elpenhaler^® device as controller, with or without treatment with low-dose (LD) BUD/FOR or short-acting beta-agonist (SABA) as a reliever. <bold>Methods:</bold> In the NOTOS study (<ext-link>NCT04835961</ext-link>) 1008 patients were categorized, according to their controller treatment, into three groups: A₁ (as-needed treatment with LD BUD/FOR), B₁ (maintenance treatment with FDC BUD/FOR 200/6μg), and C₁ (maintenance treatment with FDC BUD/FOR 400/12μg) and according to their reliever treatment with LD BUD/FOR (groups B₂, C₂) or SABA (A₂, B₃, C₃). Asthma control was assessed using the Greek version of Asthma Control Questionnaire (ACQ-6). <bold>Results:</bold> Clinically significant improvement in asthma control (MCID≥0.50 in ACQ) was observed across all groups after 6 months. The mean change (Δ) (SD) in ACQ-6 score for each group was: A₁=-0.95 (0.91), A₂=-1.11 (0.59), B₁=-1.32 (0.98), B₂=-1.40 (0.92), B₃=-1.32 (0.77), C₁=-1.58 (0.88), C₂=-1.85 (1.30) and C₃=-1.81 (0.94). <bold>Conclusion:</bold> The NOTOS study demonstrated a clinically significant improvement in asthma control for patients under controller treatment with FDC of BUD/FOR after 6 months. Notable improvement was observed in patients using LD BUD/FOR as the preferred reliever compared to those using SABA as reliever treatment.