RecruitingNCT07214753
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
Sponsor
AstraZeneca
Enrollment
335 participants
Start Date
Dec 20, 2025
Study Type
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria4
- 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 Criteria6
- 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
Interventions
BIOLOGICALbenralizumab
30mg s.c. as per SmPC
Locations(28)
View Full Details on ClinicalTrials.gov
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NCT07214753