NCT05440656

A Real World Study to Capture Clinical and Patient Centered Outcomes in Adults With Severe Eosinophilic Asthma Treated With Benralizumab.

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 152 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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 (Fasenra®), an interleukin (IL)-5-alpha receptor monoclonal antibody, is approved as an add-on maintenance treatment for SEA. This study aims at collecting real-world data that extend beyond the clinical effectiveness of benralizumab to the participant-reported impact of treatment on their HRQoL, sleep quality, depression, anxiety, work productivity and activity impairment, but also on treatment effectiveness. Recent technological advances in portable spirometers and wearable activity trackers (WAT) to increase physical activity for participants with asthma, even for older participants, allow this study to collect data on lung function parameters and physical activity from such devices for the first time at a country level in Greece. Using a multi-aspect approach, this study will generate real-world evidence on a broad range of both well-established clinical and novel patient-centered outcomes which are critical to the assessment of the therapeutic benefit both from the physician's and the participant's perspective. All main study outcomes will be examined at various timepoints throughout the course of the 48-week observation period, starting as early as 4 weeks after treatment initiation, thus enabling the identification of 'early' treatment responders with a closer focus on patients' physical and psychological well-being and HRQoL in addition to asthma control and lung function metrics

Conditions

• Severe Eosinophilic Asthma

Interventions

Type	Name	Description
DRUG	Cohort	Participants with Severe Eosinophilic Asthma

Timeline

• Start date: 2022-06-29
• Primary completion: 2025-04-13
• Completion: 2025-04-13
• First posted: 2022-07-01
• Last updated: 2026-04-15

Locations

13 sites across 1 country: Greece