BDP/FF NEXThaler to Improve Asthma Control Status in the Real World: The NEWTON Study.
Matteo BoniniEnrico ArnaboldiSara BarileLuca CavalieriEleonora IngrassiaMaria RussoAlessio PirainoPublished in: Journal of asthma and allergy (2023)
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.
Keyphrases
- patient reported outcomes
- chronic obstructive pulmonary disease
- lung function
- newly diagnosed
- clinical practice
- ejection fraction
- mental health
- public health
- stem cells
- cross sectional
- metabolic syndrome
- physical activity
- clinical trial
- drug delivery
- cystic fibrosis
- machine learning
- climate change
- high intensity
- study protocol
- replacement therapy
- deep learning
- combination therapy
- insulin resistance
- peritoneal dialysis
- placebo controlled
- phase iii