Trials / Completed
CompletedNCT04221802
Patient-reported Outcomes in Real-world Use of Benralizumab in Patients With Severe Eosinophilic Asthma in Belgium
A Multicentre Single Arm Observational Prospective Study to Assess Demographic Characteristics Burden of Disease PRO's in Uncontrolled, Severe Eosinophilic Asthma Patients Aged 18y or Older and Qualifying for Treatment With Benralizumab in BE
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 76 (actual)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
Summary
This study aims to assess health and quality of life outcomes in patients treated with benralizumab, within a Belgian Real-World setting. To prove the clinical value of benralizumab in a Real-World setting, the study will document the effect of benralizumab within a time frame of 112 weeks after initiation of treatment.
Detailed description
The aim and objective of this single arm, prospective observational study is to provide supporting RWE on the symptom relief of asthma patients qualified for benralizumab therapy in Belgium. The PRO measures consist of the Asthma Control Questionnaire (ACQ 6) as well as Patient Global Impression of Change and Severity (PGI-C and PGI-S), healthcare resource utilization (HCRU) and treatment satisfaction (TSQM-9). In addition change in daily OCS use and rate of exacerbations after initiation of benralizumab in real-world setting will be assessed
Conditions
Timeline
- Start date
- 2019-12-23
- Primary completion
- 2024-05-13
- Completion
- 2024-05-13
- First posted
- 2020-01-09
- Last updated
- 2025-05-06
Locations
10 sites across 1 country: Belgium
Source: ClinicalTrials.gov record NCT04221802. Inclusion in this directory is not an endorsement.