Impact on Quality of Life in Greek asthmatic patients receiving Budesonide/Formoterol FDC as maintenance treatment, with or without additional reliever treatment. Results from the NOTOS study.

<bold>Background & Aim:</bold> As a persistent condition, asthma affects individuals’ quality of life (QoL). The NOTOS study evaluated the QoL of Greek asthmatic patients treated with the Fixed Dose Combination (FDC) of budesonide/formoterol (BUD/FOR) via Elpenhaler^® 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 this multicenter, non-interventional, observational 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). QoL was assessed using the Greek version of Mini Asthma Quality of Life Questionnaire (MiniAQLQ). <bold>Results:</bold> The mean change (Δ)(SD) in MiniAQLQ score after 6 months of treatment, demonstrated statistically significant (p<0.001) improvements in each group, exceeding the questionnaire’s Minimal Clinically Important Difference (MCID) of 0.50, thus indicating meaningful clinical improvement: (Δ)(SD) in A₁=1.22 (0.96), A₂=1.46 (0.73), B₁=1.45 (1.03), B₂=1.57 (1.03), B₃=1.90 (1.19), C₁=1.77 (1.07), C₂=1.99 (1.23) and C₃=2.00 (1.07). <bold>Conclusion:</bold> The NOTOS study confirms the positive impact of both controller and reliever treatment with the Fixed Dose Combination of budesonide/formoterol via the Elpenhaler^® device on the QoL of asthmatic patients after 6 months of treatment.