A Non-interventional, Prospective Study With Benralizumab
NCT ID: NCT06422078
Last Updated: 2026-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2024-07-25
2027-07-31
Brief Summary
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Detailed Description
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The asthma control will be analyzed by using the Asthma Control Test (ACT) and the Asthma Impairment and Risk Questionnaire (AIRQ®) at different timepoints during the study period either collected by the investigator or self-reported by the patient. In addition, health realted quality of life will be assessed at baseline and routine follow-up visits using the mini Asthma Quality of Life Questionnaire (miniAQLQ) which is collected by the investigator. To investigate the medication intake and assess the changes in asthma medication, the patients will record their weekly medication intake in a paper-based or an electronic medication diary throughout the study.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
* History of anaphylaxis to any biologic therapy
* Prior treatment with any asthma biologic therapy within the last 6 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
18 Years
120 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Ahrensburg, , Germany
Research Site
Ansbach, , Germany
Research Site
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
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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
Research Site
Wilhelmshaven, , Germany
Research Site
Würzburg, , Germany
Research Site
Zossen, , Germany
Countries
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Central Contacts
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Other Identifiers
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D3250R00124
Identifier Type: -
Identifier Source: org_study_id
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