Capturing patient-centered outcomes using innovative technologies in adults with severe eosinophilic asthma on benralizumab: Τhe EMPOWAIR real-world study design

Severe eosinophilic asthma (SEA) is associated with poor disease control and compromised health-related quality of life (HRQoL), leading to a substantial psychosocial and economic disease burden. Benralizumab, an interleukin-5alpha receptor monoclonal antibody, is approved as an add-on maintenance treatment for SEA, yet real-world evidence of its effectiveness is limited. EMPOWAIR is a non-interventional, multicenter, 48-week prospective cohort study aiming to evaluate the clinical effectiveness and the patient-perceived impact of benralizumab on HRQoL, sleep quality, depression, anxiety, work productivity and activity impairment among SEA patients treated in routine care settings in Greece. The study will also engage advanced remote patient monitoring technologies using portable spirometers and wearable activity trackers to collect data on lung function parameters and physical activity. The study plans to consecutively enroll 150 adult patients treated by lung specialists practicing in various healthcare settings across the country over an 18-month recruitment period. Eligible patients must be newly prescribed benralizumab per the approved label. Primary data will be collected at enrollment and 4, 8, 16, 32, and 48 weeks after treatment initiation through routine clinic visits or telephone contacts as per the standard clinical practice. The primary objective is to assess the change from baseline in HRQoL, as measured by the St. George's Respiratory Questionnaire (SGRQ), and to estimate the proportion of patients achieving a minimum clinically important improvement in respiratory health status, defined as >= 4-point reduction from baseline in SGRQ total score, after 16 weeks of benralizumab treatment. The study rationale, design and protocol, are described herein.