New asthma drug shows promise in real-world greek study
NCT ID NCT05440656
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study followed 152 adults in Greece with severe eosinophilic asthma who were starting benralizumab, a medication that helps control severe asthma. Researchers measured not only standard asthma control but also quality of life, sleep, mood, and physical activity using wearable trackers over 48 weeks. The goal was to see how the drug works in routine care beyond just lung function.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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152 people
The number who actually took part.
- Started
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Jun 2022
- Finished
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Apr 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Private practices and hospital clinics specializing in the management of asthma in geographically diverse locations throughout Greece
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Research Site
Alexandroupoli, 68100, Greece
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Research Site
Athens, 11521, Greece
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Research Site
Athens, 11527, Greece
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Research Site
Athens, 12462, Greece
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Research Site
Athens, 15125, Greece
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Research Site
Athens, 17562, Greece
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Research Site
Corfu, 49100, Greece
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Research Site
Heraklion, 71500, Greece
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Research Site
Ioannina, 45500, Greece
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Research Site
Rio, 26504, Greece
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Research Site
Thessaloniki, 55535, Greece
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Research Site
Thessaloniki, 56429, Greece
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Research Site
Thessaloniki, 57010, Greece
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Other studies related to the condition(s) this trial covers.
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