NCT06422078 A Non-interventional, Prospective Study With Benralizumab
| NCT ID | NCT06422078 |
| Status | Recruiting |
| Phase | — |
| Sponsor | AstraZeneca |
| Condition | Asthma, Bronchial |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2024-07-25 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2024-07-25 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Criteria: * 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 3 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06422078 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 120 Years, studying Asthma, Bronchial. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06422078 currently recruiting?
Yes, NCT06422078 is actively recruiting participants. Contact the research team at information.center@astrazeneca.com for enrollment information.
Where is the NCT06422078 trial being conducted?
This trial is being conducted at Ahrensburg, Germany, Ansbach, Germany, Aschaffenburg, Germany, Auerbach, Germany and 11 additional locations.
Who is sponsoring the NCT06422078 clinical trial?
NCT06422078 is sponsored by AstraZeneca. The trial plans to enroll 300 participants.
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