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

AstraZeneca

Status: Enrolling

Conditions: Severe Eosinophilic Asthma

Treatments: Biological: benralizumab

Study type: Observational

Funder types: Industry

Identifiers

NCT07214753

D3250R00141

Details and patient eligibility

About

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.

Full 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.

Enrollment: 335 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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