Observational study on asthma control with benralizumab

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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

Where it's running

• Research Site
  Ahrensburg, Germany Recruiting
• Research Site
  Ansbach, Germany Recruiting
• Research Site
  Aschaffenburg, Germany Recruiting
• Research Site
  Auerbach, Germany Recruiting
• Research Site
  Augsburg, Germany Recruiting
• Research Site
  Bad Homburg, Germany Recruiting

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.