Abstract
Rationale: The goal of asthma management is to achieve and maintain optimal asthma control. Patient-reported outcomes (PROs) are critical to assess the improvement of patient’s health in a real-world setting
Objective: to assess the evolution over time of PROs in asthmatic patients, not adequately controlled with ongoing treatments and initiating therapy with extrafine beclometasone dipropionate/formoterol fumarate (BDP/FF) via NEXThaler®
Methods: Multinational (DE, ES, FR, HU, IT, RO), multicentre, prospective, observational study in 650, moderate to severe adult asthmatic patients. Previously uncontrolled subjects, initiating treatment with extrafine BDP/FF via NEXThaler® as both maintenance and maintenance and reliever therapy (MART), will be followed up for 24 weeks. Primary outcome of the study will be the proportion of patients improving their asthma control. Patient-reported outcomes, through the Bring Your Own Device technology, will be electronically monitored using: 5-item Asthma Control Questionnaire for asthma control, EQ-5D for quality of life and Test of the Adherence to Inhalers’ for the adherence to treatment. A new PRO, the “Speed of change in health feeling” questionnaire, will be validated in a subgroup of 200 patients. Relevant small airways-related parameters (through spirometry, oscillometry and plethysmography) will be collected as well as FeNO
Conclusions: There is a growing need for evaluating patient-reported outcomes in a clinical setting and developing new tools to enhance asthma control. The NEWTON study will provide a real-life assessment of patients perceived clinical benefits, in a large cohort of asthmatics in Europe
Footnotes
Cite this article as: European Respiratory Journal 2021; 58: Suppl. 65, PA561.
This abstract was presented at the 2021 ERS International Congress, in session “Prediction of exacerbations in patients with COPD”.
This is an ERS International Congress abstract. No full-text version is available. Further material to accompany this abstract may be available at www.ers-education.org (ERS member access only).
- Copyright ©the authors 2021