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

AstraZeneca335 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

335

Conditions

Severe Eosinophilic Asthma

Interventions

benralizumabBIOLOGICAL

30mg s.c. as per SmPC

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (28)

Research Site

Salerno, Battipaglia, Italy

Outcomes

Primary Outcomes

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

Time frame: 24 months

Secondary Outcomes

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).

Time frame: 3, 6, 12 and 24 months

Rate of any and SA exacerbations

annualized exacerbations rate

Time frame: 3, 6, 12 and 24 months

Mean change in Asthma Control Test (ACT) score

mean (SD) changes (min - max) overtime in ACT score

Time frame: 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

Time frame: 1, 3, 6, 12 and 24 months vs baseline

Mean change in FEV1 - pre-BD

mean (SD) changes in FEV1 (L) overtime

Time frame: 3, 6, 12 and 24 vs baseline

Mean changes in FEV1 - post-BD

mean (SD) changes in FEV1 (L) post-BD

Time frame: 3, 6, 12 and 24 months vs baseline

Central Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479 information.center@astrazeneca.com

Data from ClinicalTrials.gov

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