Détail du document
Identifiant
oai:pubmedcentral.nih.gov:1061...
Sujet
Study ProtocolAuteur
Braido, Fulvio Arnaboldi, Enrico Barile, Sara Cavalieri, Luca Ingrassia, Eleonora Russo, Maria Piraino, AlessioLangue
enEditeur
Dove
Catégorie
Journal of Asthma and Allergy
Année
2023
Date de référencement
16/08/2024
Mots clés
study asthmaRésumé
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
