Status:
RECRUITING
A Real-life Observational Study in Severe Eosinophilic Asthma Adult Participant Treated With Benralizumab in Italy
Lead Sponsor:
AstraZeneca
Conditions:
Severe Eosinophilic Asthma
Eligibility:
All Genders
18+ years
Brief 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 remi...
Detailed Description
The ATHENA study aims to expand real-world evidence on benralizumab role in clinical practice, specifically evaluating its effectiveness in achieving clinical remission (complete and partial), as defi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 20 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
335 Patients enrolled
Trial Details
Trial ID
NCT07214753
Start Date
December 20 2025
End Date
December 31 2028
Last Update
January 9 2026
Active Locations (28)
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1
AZIENDA ULSS 6 EUGANEA_OSPEDALE DI CITTADELLA U.O.C. di Pneumologia
Cittadella, Padova, Italy, 35013
2
PRESIDIO OSPEDALIERO SANTA MARIA DELLA SPERANZA U.O.C. Medicina Interna
Battipaglia, Salerno, Italy, 84031
3
OSPEDALE MARIA S.S. DELLO SPLENDORE U.O.S.D. Allergologia Territoriale presidio ospedaliero Giulianova
Giulianova, Teramo, Italy, 64021
4
AULSS2 MARCA TREVIGIANA OSPEDALE CIVILE DI MONTEBELLUNA U.O.C. di Pneumologia
Montebelluna, Treviso, Italy, 31044