Real-Life Effectiveness of Budesonide/Formoterol as Maintenance and Reliever Treatment via the Elpenhaler® Device in Patients with Asthma: The NOTOS Observational Study.
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引用次数: 0
Abstract
Aim: Inhaled corticosteroid (ICS)/long-acting β2-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 β2-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.
期刊介绍：
An international, peer-reviewed journal publishing original research, reports, editorials and commentaries on the following topics: Asthma; Pulmonary physiology; Asthma related clinical health; Clinical immunology and the immunological basis of disease; Pharmacological interventions and new therapies.
Although the main focus of the journal will be to publish research and clinical results in humans, preclinical, animal and in vitro studies will be published where they shed light on disease processes and potential new therapies.
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