oai:pubmedcentral.nih.gov:1061...
Dove
Journal of Asthma and Allergy
2023
16.08.2024
In this article, we discuss the importance of real-world data in the treatment of patients with asthma and specifically the role of maintenance and reliever therapy (MART) with beclometasone dipropionate (BDP)/formoterol fumarate dihydrate (FF) delivered through a dry-powder inhaler (DPI) that contains an extrafine formulation.
We also present the design of the NEWTON study.
This multinational, multicenter, prospective, observational study will evaluate the real-world use of extrafine BDP/FF via a DPI as maintenance therapy and MART in patients with moderate to severe asthma.
The study’s primary outcome will be the proportion of patients improving their asthma control.
Digitally collected patient-reported outcomes, such as the 5-item Asthma Control Questionnaire, the EuroQol 5-dimension 5-level, and the Test of the Adherence to Inhalers, will be used to assess the patient’s asthma control, quality of life, and treatment adherence.
Moreover, a new patient-reported outcome, the “Speed of change in health feeling” questionnaire, will be validated in a subgroup of patients.
Overall, the results of this study will provide a real-life assessment of patients who perceived clinical benefits in a large cohort of asthmatics in Europe treated as per current clinical practice.
Braido, Fulvio,Arnaboldi, Enrico,Barile, Sara,Cavalieri, Luca,Ingrassia, Eleonora,Russo, Maria,Piraino, Alessio, 2023, BDP/FF NEXThaler to Improve Asthma Control Status in the Real World: The NEWTON Study, Dove