Actively Recruiting
A Non-interventional, Prospective Study With Benralizumab to Investigate Clinical Outcome Based on Standard of Care Medication in Real-life
Led by AstraZeneca · Updated on 2026-05-19
300
Participants Needed
41
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying severe eosinophilic asthma patients who are treated with benralizumab in everyday medical settings in Germany. This prospective observational study aims to understand how well asthma is controlled, how patients quality of life is affected, changes in lung function, and medication use over time. The study focuses on patients receiving high-dose inhaled corticosteroids plus long-acting beta agonists and prescribed benralizumab according to approved guidelines. Patients will be followed for up to 52 weeks while they receive their usual benralizumab treatment without any changes directed by the study. Asthma control will be assessed using standard tests like the Asthma Control Test ACT and the Asthma Impairment and Risk Questionnaire AIRQ at various times. Quality of life will be measured with the mini Asthma Quality of Life Questionnaire miniAQLQ at the start and during routine visits. Patients will also keep a weekly record of their asthma medication intake using a paper or electronic diary. During the study, participants will have regular assessments of asthma control, lung function, and medication usage. Researchers will analyze changes in scores from questionnaires, doses of inhaled corticosteroids, and lung function measures such as forced expiratory volume and capacity. Biomarkers including eosinophils, immunoglobulin E, and exhaled nitric oxide will be monitored. The study will evaluate outcomes at baseline and weeks 12, 24, and 52 to better understand real-life effects of benralizumab treatment. Participants must be willing to regularly report their symptoms and medication use throughout the study period.
CONDITIONS
Brief Title
A Non-interventional, Prospective Study With Benralizumab
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 18 years or older
- Confirmed diagnosis of severe eosinophilic asthma treated with high-dose inhaled corticosteroids plus long-acting beta agonists
- Prescribed benralizumab treatment according to label and local reimbursement criteria
- Benralizumab treatment decision made independently of the study
- Ability and willingness to read and understand written instructions
- Signed informed consent form indicating understanding and willingness to participate
- Willingness to report asthma patient-reported outcomes every 4 weeks and medication intake weekly
You will not qualify if you...
- Participation in other observational trials influencing this study or randomized clinical trial participation within the last 3 months
- History of anaphylaxis to any biologic therapy
- Prior treatment with any asthma biologic therapy within the last 3 months
- Concurrent asthma biologic therapy
- Untreated or unresponsive helminth parasitic infection diagnosed within 24 weeks before consent
- Any other pulmonary disease impacting result interpretation
- Acute or chronic conditions limiting questionnaire completion or participation
- Current or history of malignancy within 5 years with exceptions for certain skin cancers and treated in-situ cervical carcinoma
- Pregnancy or lactation
- Any condition jeopardizing patient safety as judged by the investigator
Research Team
A
AstraZeneca Clinical Study Information Center
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