A Real-life Observational Study in Severe Eosinophilic Asthma Adult Participant Treated With Benralizumab in Italy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

335 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-20

Study Completion Date

2028-12-31

Brief Summary

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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.

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Detailed Description

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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

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Severe Eosinophilic Asthma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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benralizumab

30mg s.c. as per SmPC

Intervention Type BIOLOGICAL

Other Intervention Names

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Fasenra

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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