Skip to main content
TrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor about whether a trial is right for you.
RECRUITINGOBSERVATIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form 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 Who Should NOT Join This Trial: - 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 willing to sign a consent form 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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 * 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

Locations (20)

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
Research Site
Düsseldorf, Germany
Research Site
Ehringshausen, Germany
Research Site
Erkelenz, Germany
Research Site
Essen, Germany
Research Site
Flensburg, Germany
Research Site
Frankfurt am Main, Germany
Research Site
Garmisch-Partenkirchen, Germany
Research Site
Halle, Germany
Research Site
Hamburg, Germany
Research Site
Hanover, Germany