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A Non-interventional, Prospective Study With Benralizumab | Clinical Trials | Clareo Health

RECRUITING

A Non-interventional, Prospective Study With Benralizumab

A Non-interventional, Prospective Study With Benralizumab to Investigate Clinical Outcome Based on Standard of Care Medication in Real-life

NCT06422078•AstraZeneca

View on ClinicalTrials.gov

Summary

This is a prospective, non-interventional, single-arm, multicenter study to investigate asthma control, and health-related quality of life (HRQL), lung function and asthma medication intake in severe eosinophilic asthma patients treated with benralizumab in a real-life setting in Germany.

Detailed Description

This is a prospective observational study to investigate the asthma control and health realted quality of life (HRQL) of benralizumab treated patients in routine clinical practice, their asthma medication intake, and their changes in asthma medication during the study, up to 52 weeks. 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.

Eligibility

Age

18 - 120 years

Sex

ALL

Healthy Volunteers

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 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
+2 more criteria

Locations (41)

Research Site

Ahrensburg, Germany

Research Site

Ansbach, Germany

Research Site

Aschaffenburg, Germany

Research Site

Auerbach, Germany

Research Site

Augsburg, Germany

Research Site

Bad Homburg, Germany

Research Site

Berlin, Germany

Research Site

Cottbus, Germany

Research Site

Darmstadt, Germany

Research Site

Dresden, Germany

Key Dates

Start Date

July 25, 2024

Primary Completion Date

July 31, 2027

Completion Date

July 31, 2027

Last Updated

March 2, 2026

Enrollment

300

ESTIMATED participants

Conditions

Asthma, Bronchial

Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479 information.center@astrazeneca.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 2, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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