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Real-World study tests Benralizumab's impact on severe asthma control

NCT ID NCT06422078

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 28, 2026 · Updated 2 times

Summary

This study follows 300 adults with severe eosinophilic asthma who are prescribed benralizumab as part of their normal care in Germany. Researchers will track changes in asthma control, lung function, and medication use over one year. The goal is to see how the drug performs outside of controlled clinical trials.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
benralizumab
What this could lead to
If successful, this study could show that benralizumab helps patients with severe asthma achieve better control and reduce their need for other medications in real-world settings.
What could go wrong
This is an observational study, not a controlled trial, so results may be influenced by factors other than the drug. It is also limited to Germany, which may not apply to other populations.

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

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Dec 2027

An estimate. End dates often move.

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

The study population will consist of adult patients, who were diagnosed with severe eosinophilic asthma treated by pulmonary specialists, for whom the indication to start benralizumab therapy was received independently of study participation.

Ages

18 to 120 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 patients aged 18 years or older * Confirmed diagnosis of severe eosinophilic asthma (defined according to the European Respiratory Society and American Thoracic Society and local German guidelines) treated with high-dose inhaled corticosteroids (ICS) plus long-acting beta agonists (LABA) * Prescribed treatment with benralizumab according to label and local market reimbursement criteria * Benralizumab treatment was not part of the study decision and treatment decision was met prior and independently of the study * Patients must be able and willing to read and comprehend written instructions * After full explanation, patients must have signed an informed consent form (ICF) indicating that they understand the purpose of, and the procedures required for the study and are willing to participate in the study * Patients must be willing to report asthma patient-reported outcomes (PROs) every 4 weeks and medication intake weekly Exclusion Criteria: * Patients who participate in an observational trial that might, in the investigators' opinion, influence the assessment for current study; or participated in a randomized clinical trial in the last 3 months * History of anaphylaxis to any biologic therapy * Prior treatment with any asthma biologic therapy within the last 3 months * Concurrent asthma biologic therapy * Helminth parasitic infection diagnosed within 24 weeks prior to the date informed consent was obtained that had not been treated with, or had failed to respond to standard of care (SOC) therapy * Any other pulmonary disease than asthma that, in the investigator's point of view, would have an impact on the interpretation of results * An acute or chronic condition that, in the investigator's point of view, would limit the patient's ability to complete questionnaires or participate in this study or impact the interpretations of results * Current or history of malignancy within 5 years before the enrolment date with the following exceptions: * In-situ carcinoma of the cervix where curative therapy has been completed and patients are in remission for at least 12 months prior to enrolment date * Basal cell or superficial squamous skin cancer * Pregnancy or lactation period (status to be proactively asked by the investigator) * Any condition, that, in the opinion of the investigator, could jeopardize the safety of the patient

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Conditions

The condition(s) this trial relates to.

asthma inherited susceptibility to asthma pulmonary eosinophilia T2-high asthma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Asthma, bronchial

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    40 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Research Site

    RECRUITING

    Ahrensburg, Germany

  • Research Site

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    Ansbach, Germany

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    Aschaffenburg, Germany

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    Auerbach, Germany

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    Augsburg, Germany

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    Bad Homburg, Germany

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    Berlin, Germany

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    Cottbus, Germany

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    Darmstadt, Germany

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    Dresden, Germany

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    Düsseldorf, Germany

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    Ehringshausen, Germany

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    Erkelenz, Germany

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    Essen, Germany

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    Flensburg, Germany

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    Frankfurt am Main, Germany

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    Garmisch-Partenkirchen, Germany

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    Halle, Germany

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    Hamburg, Germany

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    Hanover, Germany

  • Research Site

    WITHDRAWN

    Heidelberg, Germany

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    Heidelberg, Germany

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    Hohenstein-Ernsttahl, Germany

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    Itzehoe, Germany

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    Jena, Germany

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    Leipzig, Germany

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    Loerrach, Germany

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    Lübeck, Germany

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    Lüneburg, Germany

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    Markkleeberg, Germany

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    Mönchengladbach, Germany

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    Neuruppin, Germany

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    Nuremberg, Germany

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    Papenburg, Germany

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    Rostock, Germany

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    Saalfeld, Germany

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    Spardorf, Germany

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    Weißenburg, Germany

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    Wilhelmshaven, Germany

  • Research Site

    RECRUITING

    Würzburg, Germany

  • Research Site

    RECRUITING

    Zossen, Germany

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