Home › Trials › NCT06422078

Observational study on asthma control with benralizumab

A Non-interventional, Prospective Study With Benralizumab to Investigate Clinical Outcome Based on Standard of Care Medication in Real-life

Observational AstraZeneca · NCT06422078

This study is testing how well benralizumab helps people with severe eosinophilic asthma manage their symptoms and improve their quality of life over a year.

Quick facts

Study typeObservational
Enrollment300 (estimated)
Ages18 Years to 120 Years
SexAll
SponsorAstraZeneca Industry-sponsored
Drugs / interventionsbenralizumab
Locations41 sites (Ahrensburg and 40 other locations)
Trial IDNCT06422078 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate asthma control, health-related quality of life, lung function, and medication intake in patients with severe eosinophilic asthma receiving benralizumab treatment in Germany. It will involve a single-arm, multicenter approach where patients will report their asthma control and medication usage over a period of up to 52 weeks. The study will utilize validated questionnaires and patient-reported outcomes to gather data on asthma management in a real-world setting.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of severe eosinophilic asthma who are currently treated with high-dose inhaled corticosteroids and long-acting beta agonists.

Not a fit: Patients who do not have severe eosinophilic asthma or are not currently receiving benralizumab treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of asthma management and improve quality of life for patients with severe eosinophilic asthma.

How similar studies have performed: Other studies have shown success in evaluating asthma treatments in real-world settings, making this approach both relevant and potentially impactful.

Eligibility criteria

Show full inclusion / exclusion 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 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

Where this trial is running

Ahrensburg and 40 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Asthma, Bronchialbenralizumabsevere eosinophilic asthmaquality of lifeasthma control
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.