Severe Eosinophilic AsthmaATHENANCT07214753
A Real-life Observational Study in Severe Eosinophilic Asthma Adult Participant Treated With Benralizumab in Italy
An observational study of Severe Eosinophilic Asthma, run by AstraZeneca at 28 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Eosinophilic Asthma
- What is being tested?
- benralizumab
- How many people
- 335 participants
- Where
- 28 sitesItaly
- Study dates
- 20 Dec 2025to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Severe eosiniphilic asthma patients treated with benralizumab as per clinical practices
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
28 sites in 1 country. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
28 sites in 1 country
Italy28 sites, 28 recruiting
- Recruiting
Research Site
Bari, 70120
- Not yet recruiting
Research Site
Bergamo, 24127
- Recruiting
Research Site
Bologna, 40138
- Not yet recruiting
Research Site
Bologna, 40139
- Not yet recruiting
Research Site
Brescia, 25123
- Not yet recruiting
Research Site
Catania, 95123
- Recruiting
Research Site
Catanzaro, 88100
- Not yet recruiting
Research Site
Florence, 50134
- Not yet recruiting
Research Site
Foggia, 71122
- Not yet recruiting
Research Site
Messina, 98124
- Recruiting
Research Site
Milan, 20142
- Recruiting
Research Site
Modena, 41125
- Recruiting
Research Site
Naples, 80131
- Not yet recruiting
Research Site
Naples, 80131
- Not yet recruiting
Research Site
Padova, Cittadella, 35013
- Not yet recruiting
Research Site
Padova, 35128
- Recruiting
Research Site
Palermo, 90127
- Not yet recruiting
Research Site
Pavia, 27100
- Not yet recruiting
Research Site
Roma, 00152
- Recruiting
Research Site
Roma, 00189
- Not yet recruiting
Research Site
Salerno, Battipaglia, 84031
- Not yet recruiting
Research Site
Sassari, 07100
- Not yet recruiting
Research Site
Siena, 53100
- Recruiting
Research Site
Teramo, Giulianova, 64021
- Recruiting
Research Site
Torino, 10128
- Recruiting
Research Site
Treviso, Montebelluna, 31044
- Recruiting
Research Site
Varese, Tradate, 21049
- Not yet recruiting
Research Site
Verona, 37134
About this study
Official title: 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
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.
Read the 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 defined by SANI. Additionally, given the growing importance of biomarkers in asthma research, this study seeks to further investigate benralizumab immunological effects, potentially contributing to a deeper understanding of asthma pathophysiology and addressing existing knowledge conundrum. Additionally, the study will consolidate long-term safety data.
- Conditions
- Severe Eosinophilic Asthma
- Being tested
- benralizumab
- Medical subject headings
- Pulmonary Eosinophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
benralizumabBiological
Also called Fasenra
30mg s.c. as per SmPC
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 months
Secondary outcomes (16)
Number and percentage of patients achieving the criteria for clinical remission
Number and percentage of patient with the criteria for complete or partial remission according to the following criteria: No need to use OCS; Absence of asthma symptoms (ACT score from 20/25 to 25/25); Absence of asthma exacerbations; Stable lung function (FEV1 decline of no more than 100 mL).
Measured: 3, 6, 12 and 24 months
Rate of any and SA exacerbations
annualized exacerbations rate
Measured: 3, 6, 12 and 24 months
Mean change in Asthma Control Test (ACT) score
mean (SD) changes (min - max) overtime in ACT score
Measured: 1, 3, 6, 12 and 24 months vs baseline
Mean changes in Asthma Control Questionnaire (ACQ) score
mean (SD) changes (min - max) overtime in ACQ score
Measured: 1, 3, 6, 12 and 24 months vs baseline
Mean change in FEV1 - pre-BD
mean (SD) changes in FEV1 (L) overtime
Measured: 3, 6, 12 and 24 vs baseline
Mean changes in FEV1 - post-BD
mean (SD) changes in FEV1 (L) post-BD
Measured: 3, 6, 12 and 24 months vs baseline
Mean changes in FEV1 % predicted - pre-BD
mean (SD) changes in FEV1 % predicted pre-BD
Measured: 3, 6, 12 and 24 months vs baseline
Mean changes in FEV1 % predicted - post-BD
mean (SD) changes in FEV1 % predicted post-BD
Measured: 3, 6, 12 and 24 months vs baseline
Mean changes in FVC pre-BD
mean (SD) changes in FVC (L) pre-BD
Measured: 3, 6, 12 and 24 months vs baseline
Mean changes in FVC post-BD
mean (SD) changes in FVC (L) post-BD
Measured: 3, 6, 12 and 24 months vs baseline
Mean changes in pre-BD FEV1/FVC
mean (SD) changes in pre-BD FEV1/FVC (ratio)
Measured: 3, 6, 12 and 24 months vs baseline
Mean changes in pre-BD FEF 25-75
mean (SD) changes in pre_BD FEF25-75 (L/sec)
Measured: 3, 6, 12 and 24 months vs baseline
Mean changes in post-BD FEF 25-75
mean (SD) changes in post-BD FEF25-75 (L/sec)
Measured: 3, 6, 12 and 24 months vs baseline
Mean changes in post-BD FEV1/FVC
mean (SD) changes in post-BD FEV1/FVC (ratio)
Measured: 3, 6, 12 and 24 months vs baseline
Change in inhaled maintenance therapy and inhaled corticosteroid (ICS/LABA/LAMA, ICS/LABA) use and dosage
Change in inhaled maintenance therapy and inhaled corticosteroid (ICS/LABA/LAMA, ICS/LABA) use and dosage after benralizumab treatment
Measured: 3, 6, 12 and 24 months
Change in mOCS use and daily dose
Change in mOCS use and daily dose after benralizumab administartion
Measured: 3, 6, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start20 Dec 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Eosinophilic AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 335 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07214753
- Sponsor's protocol ID
- D3250R00141
- Acronym
- ATHENA
- Status last verified
- Sep 2026
- First submitted
- 6 Oct 2025
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07214753
- Acronym / sponsor ID
- ATHENA / D3250R00141
- Conditions
- Severe Eosinophilic Asthma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 335 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 9 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 defined by SANI. Additionally, given the growing importance of biomarkers in asthma research, this study seeks to further investigate benralizumab immunological effects, potentially contributing to a deeper understanding of asthma pathophysiology and addressing existing knowledge conundrum. Additionally, the study will consolidate long-term safety data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Severe eosiniphilic asthma patients treated with benralizumab as per clinical practices
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| benralizumabAlso: Fasenra30mg s.c. as per SmPC | Biological | – |
Primary outcome
Number and percentage of patients achieving clinical remission, partial and complete, as per SANI Definition
Time frame: 24 months
Number and percentage of patient who met the 4 remission criteria (complete or partial) at 12 months and maintained up to 24months
16 secondary outcomes
Number and percentage of patients achieving the criteria for clinical remission
Time frame: 3, 6, 12 and 24 months
Rate of any and SA exacerbations
Time frame: 3, 6, 12 and 24 months
Mean change in Asthma Control Test (ACT) score
Time frame: 1, 3, 6, 12 and 24 months vs baseline
Mean changes in Asthma Control Questionnaire (ACQ) score
Time frame: 1, 3, 6, 12 and 24 months vs baseline
Mean change in FEV1 - pre-BD
Time frame: 3, 6, 12 and 24 vs baseline
Mean changes in FEV1 - post-BD
Time frame: 3, 6, 12 and 24 months vs baseline
Mean changes in FEV1 % predicted - pre-BD
Time frame: 3, 6, 12 and 24 months vs baseline
Mean changes in FEV1 % predicted - post-BD
Time frame: 3, 6, 12 and 24 months vs baseline
Mean changes in FVC pre-BD
Time frame: 3, 6, 12 and 24 months vs baseline
Mean changes in FVC post-BD
Time frame: 3, 6, 12 and 24 months vs baseline
Mean changes in pre-BD FEV1/FVC
Time frame: 3, 6, 12 and 24 months vs baseline
Mean changes in pre-BD FEF 25-75
Time frame: 3, 6, 12 and 24 months vs baseline
Mean changes in post-BD FEF 25-75
Time frame: 3, 6, 12 and 24 months vs baseline
Mean changes in post-BD FEV1/FVC
Time frame: 3, 6, 12 and 24 months vs baseline
Change in inhaled maintenance therapy and inhaled corticosteroid (ICS/LABA/LAMA, ICS/LABA) use and dosage
Time frame: 3, 6, 12 and 24 months
Change in mOCS use and daily dose
Time frame: 3, 6, 12 and 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
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Blood Exosomal Multi-omics and Lung Radiomics for Predicting Efficacy and Prognosis of Severe Eosinophilic ACOS With Biologics
Severe Eosinophilic ACOS (Asthma-COPD Overlap)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AstraZeneca Clinical Study Information Center contact
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Eosinophilic Asthma, run by AstraZeneca at 28 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and percentage of patients achieving clinical remission, partial and complete, as per SANI Definition (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.