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NCT05440656

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

Sponsor: AstraZeneca

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

152

Start Date

2022-06-29

Completion Date

2025-04-13

Last Updated

2026-04-15

Healthy Volunteers

No

Interventions

DRUG

Cohort

Participants with Severe Eosinophilic Asthma

Locations (13)

Research Site

Alexandroupoli, Greece

Research Site

Athens, Greece

Research Site

Athens, Greece

Research Site

Athens, Greece

Research Site

Athens, Greece

Research Site

Athens, Greece

Research Site

Corfu, Greece

Research Site

Heraklion, Greece

Research Site

Ioannina, Greece

Research Site

Rio, Greece

Research Site

Thessaloniki, Greece

Research Site

Thessaloniki, Greece

Research Site

Thessaloniki, Greece