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New asthma drug shows promise in real-world greek study

NCT ID NCT05440656

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

152 people

The number who actually took part.

Started

Jun 2022

Finished

Apr 2025

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

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

  • Research Site

    Alexandroupoli, 68100, Greece

  • Research Site

    Athens, 11521, Greece

  • Research Site

    Athens, 11527, Greece

  • Research Site

    Athens, 12462, Greece

  • Research Site

    Athens, 15125, Greece

  • Research Site

    Athens, 17562, Greece

  • Research Site

    Corfu, 49100, Greece

  • Research Site

    Heraklion, 71500, Greece

  • Research Site

    Ioannina, 45500, Greece

  • Research Site

    Rio, 26504, Greece

  • Research Site

    Thessaloniki, 55535, Greece

  • Research Site

    Thessaloniki, 56429, Greece

  • Research Site

    Thessaloniki, 57010, Greece

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