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NCT07214753Recruiting

A Real-life Observational Study in Severe Eosinophilic Asthma Adult Participant Treated With Benralizumab 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

Source: ClinicalTrials.gov · Last updated 18 Sept 2026

Brief summary (registry, in English)

This is an observational, multicenter, prospective study on patients with severe eosinophilic asthma treated with benralizumab aimed at evaluating the achievement of partial and complete clinical remission.

Status (registry)
Recruiting
Study type
Observational
Enrollment
335 (estimated)
First submitted
6 Oct 2025
Start date
20 Dec 2025
Primary completion date
31 Dec 2028
Lead sponsor
AstraZeneca
Diseases
Asthma
NCT number
NCT07214753

What you commit to

  • Study type: Observational
  • Planned participants: 335
  • From 20 Dec 2025 to the primary completion date, 31 Dec 2028
  • 24 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

  • 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.
  • Previous or concomitant use of omalizumab, reslizumab, dupilumab, tezepelumab or mepolizumab without washout period as per clinical practice

Other illness

  • 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.

Other

  • Contraindication to benralizumab as per current Summary of Product Characteristics (SmPC).
  • Pregnant or lactating women.

Who the study is looking for

  • 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).

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (24)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Research Site
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BariItalyRecruiting
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BergamoItalyNot yet recruiting
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BolognaItalyRecruiting
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BresciaItalyNot yet recruiting
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CataniaItalyNot yet recruiting
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CatanzaroItalyRecruiting
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FlorenceItalyNot yet recruiting
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FoggiaItalyNot yet recruiting
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MessinaItalyNot yet recruiting
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MilanItalyRecruiting
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ModenaItalyRecruiting
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NaplesItalyRecruiting
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PadovaItalyNot yet recruiting
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PalermoItalyRecruiting
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PaviaItalyNot yet recruiting
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RomaItalyNot yet recruiting
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SalernoItalyNot yet recruiting
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SassariItalyNot yet recruiting
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SienaItalyNot yet recruiting
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TeramoItalyRecruiting
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TorinoItalyRecruiting
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TrevisoItalyRecruiting
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VareseItalyRecruiting
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VeronaItalyNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.