A Real-life Observational Study in Severe Eosinophilic Asthma Adult Participant Treated With Benralizumab in Italy
ATHENA
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
1 other identifier
observational
335
1 country
28
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 remission.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2025
Typical duration for all trials
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 6, 2025
CompletedFirst Posted
Study publicly available on registry
October 9, 2025
CompletedStudy Start
First participant enrolled
December 20, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
April 9, 2026
April 1, 2026
3 years
October 6, 2025
April 8, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Number and percentage of patients achieving clinical remission, partial and complete, as per SANI Definition
Number and percentage of patient who met the 4 remission criteria (complete or partial) at 12 months and maintained up to 24months
24 months
Secondary Outcomes (16)
Number and percentage of patients achieving the criteria for clinical remission
3, 6, 12 and 24 months
Rate of any and SA exacerbations
3, 6, 12 and 24 months
Mean change in Asthma Control Test (ACT) score
1, 3, 6, 12 and 24 months vs baseline
Mean changes in Asthma Control Questionnaire (ACQ) score
1, 3, 6, 12 and 24 months vs baseline
Mean change in FEV1 - pre-BD
3, 6, 12 and 24 vs baseline
- +11 more secondary outcomes
Interventions
Eligibility Criteria
Severe eosiniphilic asthma patients treated with benralizumab as per clinical practices
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (28)
Research Site
Salerno, Battipaglia, 84031, Italy
Research Site
Padova, Cittadella, 35013, Italy
Research Site
Teramo, Giulianova, 64021, Italy
Research Site
Treviso, Montebelluna, 31044, Italy
Research Site
Varese, Tradate, 21049, Italy
Research Site
Bari, 70120, Italy
Research Site
Bergamo, 24127, Italy
Research Site
Bologna, 40138, Italy
Research Site
Bologna, 40139, Italy
Research Site
Brescia, 25123, Italy
Research Site
Catania, 95123, Italy
Research Site
Catanzaro, 88100, Italy
Research Site
Florence, 50134, Italy
Research Site
Foggia, 71122, Italy
Research Site
Messina, 98124, Italy
Research Site
Milan, 20142, Italy
Research Site
Modena, 41125, Italy
Research Site
Naples, 80131, Italy
Research Site
Naples, 80131, Italy
Research Site
Padova, 35128, Italy
Research Site
Palermo, 90127, Italy
Research Site
Pavia, 27100, Italy
Research Site
Roma, 00152, Italy
Research Site
Roma, 00189, Italy
Research Site
Sassari, 07100, Italy
Research Site
Siena, 53100, Italy
Research Site
Torino, 10128, Italy
Research Site
Verona, 37134, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2025
First Posted
October 9, 2025
Study Start
December 20, 2025
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2028
Last Updated
April 9, 2026
Record last verified: 2026-04