RecruitingNCT06422078
A Non-interventional, Prospective Study With Benralizumab
A Non-interventional, Prospective Study With Benralizumab to Investigate Clinical Outcome Based on Standard of Care Medication in Real-life
Sponsor
AstraZeneca
Enrollment
300 participants
Start Date
Jul 25, 2024
Study Type
OBSERVATIONAL
Conditions
Summary
This is a prospective, non-interventional, single-arm, multicenter study to investigate asthma control, and health-related quality of life (HRQL), lung function and asthma medication intake in severe eosinophilic asthma patients treated with benralizumab in a real-life setting in Germany.
Eligibility
Min Age: 18 YearsMax Age: 120 Years
Inclusion Criteria7
- Male or female patients aged 18 years or older
- Confirmed diagnosis of severe eosinophilic asthma (defined according to the European Respiratory Society and American Thoracic Society and local German guidelines) treated with high-dose inhaled corticosteroids (ICS) plus long-acting beta agonists (LABA)
- Prescribed treatment with benralizumab according to label and local market reimbursement criteria
- Benralizumab treatment was not part of the study decision and treatment decision was met prior and independently of the study
- Patients must be able and willing to read and comprehend written instructions
- After full explanation, patients must have signed an informed consent form (ICF) indicating that they understand the purpose of, and the procedures required for the study and are willing to participate in the study
- Patients must be willing to report asthma patient-reported outcomes (PROs) every 4 weeks and medication intake weekly
Exclusion Criteria12
- Patients who participate in an observational trial that might, in the investigators' opinion, influence the assessment for current study; or participated in a randomized clinical trial in the last 3 months
- History of anaphylaxis to any biologic therapy
- Prior treatment with any asthma biologic therapy within the last 6 months
- Concurrent asthma biologic therapy
- Helminth parasitic infection diagnosed within 24 weeks prior to the date informed consent was obtained that had not been treated with, or had failed to respond to standard of care (SOC) therapy
- Any other pulmonary disease than asthma that, in the investigator's point of view, would have an impact on the interpretation of results
- An acute or chronic condition that, in the investigator's point of view, would limit the patient's ability to complete questionnaires or participate in this study or impact the interpretations of results
- Current or history of malignancy within 5 years before the enrolment date with the following exceptions:
- In-situ carcinoma of the cervix where curative therapy has been completed and patients are in remission for at least 12 months prior to enrolment date
- Basal cell or superficial squamous skin cancer
- Pregnancy or lactation period (status to be proactively asked by the investigator)
- Any condition, that, in the opinion of the investigator, could jeopardize the safety of the patient
Locations(41)
View Full Details on ClinicalTrials.gov
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NCT06422078