Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-24 @ 11:16 PM
NCT ID:
NCT05440656
Eligibility Criteria:
Inclusion Criteria:
* Male or female outpatients aged 18 to 75 years (inclusive) at the time of benralizumab prescription
* Patients with physician-diagnosed Severe Eosinophilic Asthma SEA inadequately controlled despite high-dose inhaled corticosteroids (ICS) plus long-acting β-agonists (LABA)
* Patients who have been prescribed but not yet initiated treatment with benralizumab according to the Summary of Product Characteristics (SmPC), prior to signed Informed Consent, and for whom the decision to prescribe this therapy is clearly separated from the physician's decision to include the patient in the current study
* For patients that are not Oral Corticosteroid (OCS)-dependent: Blood eosinophil count (BEC) ≥150 cells/μL in the 2 weeks before benralizumab initiation and a historical value of ≥300 cells/μL during the previous year
* For OCS-dependent patients: BEC ≥150 cells/μL in the 2 weeks before benralizumab initiation or a historical value of ≥300 cells/μL during the previous year
* History of ≥1 documented Clinically Significant Exacerbations (CSE) in the 48 weeks prior to benralizumab initiation, and of ≥2 CSEs in the previous 24 months
* Patients must be willing and able to read and complete the study specific questionnaires
* Patients must be willing and able to use the study-specific wearable/handheld devices.
Note: This requirement applies only at the time of benralizumab (Fasenra®) prescription. If a patient stops using any or both of the aforementioned devices for any reason during his/her participation in the study, (s)he may continue participating in the study and this will not be considered as a reason for withdrawal.
-Patients must provide a written Informed Consent prior to inclusion to the study
Exclusion Criteria:
* Patients that meet any of the contraindications to the administration of the benralizumab outlined in the SmPC
* Concomitant treatment with any other biologic agent for any indication
* Previous exposure to anti-IL5/ILR5 treatment
* Exposure to omalizumab in the past 6 months prior to benralizumab initiation
* Clinically important pulmonary disease other than asthma or ever been diagnosed with any disease, other than asthma, that is associated with elevated BEC
* Acute upper or lower respiratory infections within 8 weeks prior to the date of informed consent
* Heavy smokers with a \>20 pack-year smoking history
* Currently pregnant (or intention to become pregnant within the study period), breastfeeding or lactating women
* Known evidence of lack of adherence to asthma controller medications
* Use of immunosuppressive medication (including but not limited to: OCS \[for reasons other than asthma\], methotrexate, troleandomycin, cyclosporine, azathioprine, intramuscular long-acting depot corticosteroids \[for reasons other than asthma\] or any experimental anti-inflammatory therapy) within 3 months prior to the date of informed consent
* Patients who currently receive treatment with any investigational drug/device/intervention or who have received any investigational product within 30 days or 5 half-lives of the investigational agent (whichever is longer) before benralizumab initiation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05440656
Study Brief:
Protocol Section:
NCT05440656