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Recruiting NCT07214753

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

— Observational Severe Eosinophilic Asthma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: benralizumab.
Who it may be relevant to
Registry conditions: Severe Eosinophilic Asthma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

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.

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.

Interventions

  • Biological benralizumab
    30mg s.c. as per SmPC

Primary outcome measures

  • Number and percentage of patients achieving clinical remission, partial and complete, as per SANI Definition [Time frame: 24 months]
Secondary outcome measures (12)
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 28 centers
  • Research Site — Salerno
  • Research Site — Padova
  • Research Site — Teramo
  • Research Site — Treviso
  • Research Site — Varese
  • Research Site — Bari
  • Research Site — Bergamo
  • Research Site — Bologna
  • … and 20 more centers

Identifiers

NCT: NCT07214753 · D3250R00141

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗