NCT06422078Recruiting
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
Source: ClinicalTrials.gov · Last updated 28 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 300 (estimated)
- First submitted
- 15 May 2024
- Start date
- 25 Jul 2024
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- AstraZeneca
- Diseases
- Asthma
- NCT number
- NCT06422078
What you commit to
- Study type: Observational
- Planned participants: 300
- From 25 Jul 2024 to the primary completion date, 31 Dec 2027
- 40 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- History of anaphylaxis to any biologic 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
- Any condition, that, in the opinion of the investigator, could jeopardize the safety of the patient
Other
- 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
- Pregnancy or lactation period (status to be proactively asked by the investigator)
Who the study is looking for
- 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
Age in the registry: 18 years to 120 years · Sex: All · Does not accept healthy volunteers
Sites (40)
Sites in registry order. Save your city in your profile to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.