EMPOWAIR: A real-world, multicenter, prospective cohort study using innovative remote patient monitoring technologies in adults with severe eosinophilic asthma treated with Benralizumab in routine care settings in Greece

INTRODUCTION

Asthma is a chronic respiratory disease that encompasses a broad spectrum of phenotypes and endotypes. Approximately 5-10% of patients with asthma suffer from severe disease, which cannot be adequately controlled by conventional treatment with a high dose of inhaled corticosteroids combined with long-acting β2-agonists or oral corticosteroids (OCS), or control is lost when de-escalating treatment. Based on a 2021 report of the International Severe Asthma Registry, in >80% of patients with severe asthma, the disease is characterized by the presence of eosinophilia, which causes inflammation and hyperresponsiveness of the airways, and is referred to as severe eosinophilic asthma (SEA). Patients with SEA experience substantial symptom burden and frequent disease exacerbations, which contribute to disease-related morbidity and progressive loss of lung function. Benralizumab is a monoclonal antibody (mAb) approved for add-on biologic treatment of SEA, in 2017 and 2018 in the USA and Europe, respectively.

STUDY DESIGN- RESEARCH OBJECTIVES

EMPOWAIR (“A rEal-world, Multicenter, 48-week Prospective cohort study to capture clinical and patient-centered Outcomes in adults With severe eosinophilic Asthma treated wIth benRalizumab in routine care settings in Greece”, NCT05440656) is a single-country, non-interventional, multicenter, 48-week prospective cohort study which will include adult patients with SEA initiated on benralizumab in routine care settings of Greece. The study will be carried out by 20-25 sites comprising private practices and hospital clinics specializing in the management of asthma in geographically diverse locations throughout Greece.The overall duration of the study is expected to be approximately 126 weeks (~29 months), including a recruitment period of 78 weeks and an observation period of 48 weeks.

DATA COLLECTION

1. Primary data will be collected at enrollment and study visits
2. Study-specific physical activity data will be collected using a WAT device (Fitbit® wristband).
3. For the home-based spirometric measurements, patients will be provided the portable hand-held Air Next spirometer.
4. Secondary data will be abstracted from patients’ medical records and through patient self-report

PRIMARY OBJECTIVE

• To assess the change from baseline in HRQoL (measured by the SGRQ) and to estimate the proportion of patients achieving a minimum clinically important improvement in respiratory health status after 16 weeks of treatment with benralizumab.

DISCUSSION

EMPOWAIR employs a multifaceted approach to assess the effect of benralizumab treatment on clinical and patient-centered outcomes in patients with SEA treated in routine care settings in Greece.

• The study will make use of portable spirometers and WATs, handled by the patients themselves, to measure and record spirometric parameters and physical activity, respectively.
• This is the first time that such technological devices are being used in a real-world study of asthma at a country-level in Greece.
• The devices are thought to empower patients in their everyday asthma self-management with no intention to interfere with clinicians’ decision-making and patient treatment plan.
• The study outcomes will be enhanced by enrolling patients from geographically diverse locations throughout Greece, accounting for variations in medical practice paradigms.