Severe Eosinophilic Asthma
Conditions
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.
Interventions
BIOLOGICALbenralizumab
30mg s.c. as per SmPC
Sponsors
AstraZeneca
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number and percentage of patients achieving clinical remission, partial and complete, as per SANI Definition | 24 months | Number and percentage of patient who met the 4 remission criteria (complete or partial) at 12 months and maintained up to 24months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number and percentage of patients achieving the criteria for clinical remission | 3, 6, 12 and 24 months | 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). |
| Rate of any and SA exacerbations | 3, 6, 12 and 24 months | annualized exacerbations rate |
| Mean change in Asthma Control Test (ACT) score | 1, 3, 6, 12 and 24 months vs baseline | mean (SD) changes (min - max) overtime in ACT score |
| Mean changes in Asthma Control Questionnaire (ACQ) score | 1, 3, 6, 12 and 24 months vs baseline | mean (SD) changes (min - max) overtime in ACQ score |
| Mean change in FEV1 - pre-BD | 3, 6, 12 and 24 vs baseline | mean (SD) changes in FEV1 (L) overtime |
| Mean changes in FEV1 - post-BD | 3, 6, 12 and 24 months vs baseline | mean (SD) changes in FEV1 (L) post-BD |
| Mean changes in FEV1 % predicted - pre-BD | 3, 6, 12 and 24 months vs baseline | mean (SD) changes in FEV1 % predicted pre-BD |
| Mean changes in FEV1 % predicted - post-BD | 3, 6, 12 and 24 months vs baseline | mean (SD) changes in FEV1 % predicted post-BD |
| Mean changes in FVC pre-BD | 3, 6, 12 and 24 months vs baseline | mean (SD) changes in FVC (L) pre-BD |
| Mean changes in FVC post-BD | 3, 6, 12 and 24 months vs baseline | mean (SD) changes in FVC (L) post-BD |
| Mean changes in pre-BD FEV1/FVC | 3, 6, 12 and 24 months vs baseline | mean (SD) changes in pre-BD FEV1/FVC (ratio) |
| Mean changes in pre-BD FEF 25-75 | 3, 6, 12 and 24 months vs baseline | mean (SD) changes in pre\_BD FEF25-75 (L/sec) |
| Mean changes in post-BD FEF 25-75 | 3, 6, 12 and 24 months vs baseline | mean (SD) changes in post-BD FEF25-75 (L/sec) |
| Mean changes in post-BD FEV1/FVC | 3, 6, 12 and 24 months vs baseline | mean (SD) changes in post-BD FEV1/FVC (ratio) |
| Change in inhaled maintenance therapy and inhaled corticosteroid (ICS/LABA/LAMA, ICS/LABA) use and dosage | 3, 6, 12 and 24 months | Change in inhaled maintenance therapy and inhaled corticosteroid (ICS/LABA/LAMA, ICS/LABA) use and dosage after benralizumab treatment |
| Change in mOCS use and daily dose | 3, 6, 12 and 24 months | Change in mOCS use and daily dose after benralizumab administartion |
Countries
Italy
Contacts
CONTACTAstraZeneca Clinical Study Information Center
Outcome results
None listed