Real-world benralizumab treatment for adults with severe eosinophilic asthma in Italy

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 is a prospective, multicenter observational study enrolling adults with severe uncontrolled eosinophilic asthma who are starting benralizumab in routine clinical practice. The study will track clinical outcomes using SANI definitions to document partial and complete clinical remission, and will collect biomarker and immunological data to explore drug effects. Data will be gathered at participating Italian centers and used to expand long-term real-world safety and effectiveness evidence. No experimental treatments are assigned; patients receive benralizumab per approved label and local reimbursement rules.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adults (≥ 18 years old) diagnosed with severe uncontrolled eosinophilic asthma.
* Benralizumab has been prescribed according to the approved label and local reimbursement criteria
* Provision of signed Informed Consent Form (ICF) prior to any study-related activities
* Benralizumab has been initiated within 7 days prior to study enrollment or is planned to be initiated within 7 days after enrollment (in the latter case, provided that the decision to prescribe benralizumab is made prior to the decision to enroll the patient in the study).

Exclusion Criteria:

* Benralizumab treatment within the 12 months prior to study enrollment and up to 8 days before enrollment
* Previous participation (in the 12 months before enrollment), current participation or plan to participate within the follow up period to any other clinical trial.
* Contraindication to benralizumab as per current Summary of Product Characteristics (SmPC).
* Pregnant or lactating women.
* patients with any clinical condition that may interfere with the subject's ability to cooperate and comply with the study procedures based on the Investigator's judgement.
* Previous or concomitant use of omalizumab, reslizumab, dupilumab, tezepelumab or mepolizumab without washout period as per clinical practice

Where it's running

• Research Site
  Teramo, Giulianova, Italy Recruiting
• Research Site
  Treviso, Montebelluna, Italy Recruiting
• Research Site
  Varese, Tradate, Italy Recruiting
• Research Site
  Bari, Italy Recruiting
• Research Site
  Bologna, Italy Recruiting
• Research Site
  Catanzaro, Italy Recruiting

Study contacts

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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Continued benralizumab for participants who completed a prior benralizumab study

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• Investigating benralizumab for children with eosinophilic diseases

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• Observational study on asthma control with benralizumab

  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.

  Recruiting at 40 sites AstraZeneca · Ahrensburg and 40 other locations · NCT06422078

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.