A Real-life Observational Study in Severe Eosinophilic As... | NCT07214753

Status Module

Record Verification Date

Jul 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 20, 2025Actual

Primary Completion Date

Dec 31, 2028Estimated

Completion Date

Dec 31, 2028Estimated

First Submitted Date

Oct 6, 2025

First Submission Date that Met QC Criteria

Oct 6, 2025

First Posted Date

Oct 9, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 7, 2026

Last Update Posted Date

Jul 8, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

335Estimated

Name	Type	Description	Arm Group Labels	Other Names
benralizumab	Biological	30mg s.c. as per SmPC		Fasenra

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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).	3, 6, 12 and 24 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Severe eosiniphilic asthma patients treated with benralizumab as per clinical practices

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
AstraZeneca Clinical Study Information Center	Contact	1-877-240-9479		information.center@astrazeneca.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site	Not yet recruiting	Salerno	Battipaglia	84031	Italy
Research Site

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D017681	Hypereosinophilic Syndrome
D004802	Eosinophilia
D007960	Leukocyte Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases