BDP/FF NEXThaler to Improve Asthma Control Status in the Real World: The NEWTON Study

Fulvio Braido,1,2 Enrico Arnaboldi,1,2 Sara Barile,3 Luca Cavalieri,4 Eleonora Ingrassia,4 Maria Russo,1,2 Alessio Piraino4 1Respiratory Unit for Continuity of Care, IRCCS, Ospedale Policlinico San Martino, Genova, Italy; 2Department of Internal Medicine (DiMI), University of Genova, Genova, Italy; 3Chiesi Farmaceutici S.p.A., Parma, Italy; 4Chiesi Italia S.p.A ., Parma, ItalyCorrespondence: Fulvio Braido, Respiratory Unit for Continuity of Care, IRCCS, Ospedale Policlinico San Martino, Genova, Italy, Email fulvio.braido@unige.itAbstract: 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.Keywords: asthma, dry-powder inhaler, beclometasone dipropionate/formoterol fumarate, observational study