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

ItAlian, Multicenter, Observational, Prospective sTudy to Evaluate the acHievement of Clinical rEmission and immuNomodulation in Severe Eosinophilic Asthma Patients Treated With Benralizumab - the ATHENA Study

Observational AstraZeneca · NCT07214753

This study will test whether benralizumab helps adults with severe eosinophilic asthma reach partial or complete clinical remission during routine care in Italy.

Quick facts

Study typeObservational
Enrollment335 (estimated)
Ages18 Years and up
SexAll
SponsorAstraZeneca Industry-sponsored
Drugs / interventionsBenralizumab, omalizumab, reslizumab, dupilumab, tezepelumab, mepolizumab
Locations28 sites (Salerno, Battipaglia and 27 other locations)
Trial IDNCT07214753 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18 years) with severe uncontrolled eosinophilic asthma who have been prescribed benralizumab according to the approved label and local reimbursement criteria and can enroll within about a week of starting therapy are ideal candidates.

Not a fit: Patients who recently received benralizumab (within 12 months), are pregnant or breastfeeding, have contraindications to benralizumab, or have non-eosinophilic asthma phenotypes are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, the study could show that benralizumab helps more patients achieve partial or complete remission and reduces severe asthma attacks and steroid use.

How similar studies have performed: Randomized trials and real-world reports have shown benralizumab reduces exacerbations and blood eosinophils, but applying SANI-defined clinical remission as a primary real-world endpoint is less established and relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Salerno, Battipaglia and 27 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 Severe Eosinophilic Asthma
Last reviewed 2026-06-10 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.