Real-Life Effectiveness of Budesonide/Formoterol as Maintenance and Reliever Treatment via the Elpenhaler® Device in Patients with Asthma: The NOTOS Observational Study

Athena Gogali,1 Nikoletta Rovina,2 Konstantinos Samitas,3 Paschalis Steiropoulos,4 Dimitrios Potonos,3 Maria Bertoli,5 Polyanthi Papanastasiou,5 Alexandros Ginis,5 Konstantinos Kostikas1 1Respiratory Medicine Department, University of Ioannina, Ioannina, Greece; 2 1st Department of Respiratory Medicine, Medical School, National and Kapodistrian University of Athens and “Sotiria” Chest Hospital, Athens, Greece; 3 7th Respiratory Medicine Department, “Sotiria” Chest Hospital, Athens, Greece; 4Department of Pulmonology, University General Hospital of Alexandroupolis, Alexandroupoli, Greece; 5Medical Department, ELPEN Pharmaceutical Co. Inc., Attica, GreeceCorrespondence: Konstantinos Kostikas, Respiratory Medicine Department, University of Ioannina, Ioannina, Greece, Email [email protected]: Inhaled corticosteroid (ICS)/long-acting β 2-agonist combinations are crucial for the effective treatment of asthma. ICS/formoterol regimens serve both as controller and reliever medications, as recommended by GINA 2019 onwards. In the six-month real-life NOTOS study, we aimed to evaluate the real-life effectiveness of budesonide/formoterol (BUD/FOR) administered with the Elpenhaler® device as controller and/or reliever medication on asthma control, quality of life, and lung function in patients with asthma.Methods: We performed a multicenter open-label observational prospective study of adult asthma patients receiving BUD/FOR via Elpenhaler. Assessments were performed with Asthma Control Questionnaire (ACQ-6), Mini Asthma Quality of Life Questionnaire (MiniAQLQ), and spirometry. The incidence of exacerbations, frequency of rescue therapy use, and safety data were also recorded.Results: In the 1107 patients recruited, we observed statistical and clinically relevant improvements at 6 months from baseline, in ACQ-6 [mean change (95% CI) − 1.55 (− 1.61, − 1.4) points, p< 0.001], MiniAQLQ [1.76 (1.68, 1.82) points, p< 0.001], and FEV1 [0.35 (0.31,0.38) L, p< 0.001]. Subgroup analyses, according to the maintenance (A: BUD/FOR 200/6 μg “as needed”, B: BUD/FOR 200/6 maintenance, or C: BUD/FOR 400/12 μg maintenance) and the reliever treatments (none, BUD/FOR or short-acting β 2-agonists), showed significant improvements across all groups, with greater improvements observed in the higher maintenance dose of BUD/FOR group. The frequency of rescue therapy use was overall markedly reduced, and we observed no safety issues.Conclusion: In this real-life study, treatment with BUD/FOR, as controller and/or reliever via the Elpenhaler device, was associated with significant improvement in patients’ asthma control, quality of life, and lung function, over 6 months.Keywords: asthma control, quality of life, budesonide, formoterol, maintenance and reliever treatment, Elpenhaler, real-life study