Phase
Condition
Asthma
Treatment
N/AClinical Study ID
Ages 18-120 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female patients aged 18 years or older
Confirmed diagnosis of severe eosinophilic asthma (defined according to the EuropeanRespiratory 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 marketreimbursement criteria
Benralizumab treatment was not part of the study decision and treatment decision wasmet 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 thestudy and are willing to participate in the study
Patients must be willing to report asthma patient-reported outcomes (PROs) every 4weeks and medication intake weekly
Exclusion
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 randomizedclinical 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 informedconsent was obtained that had not been treated with, or had failed to respond tostandard 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 limitthe patient's ability to complete questionnaires or participate in this study orimpact the interpretations of results
Current or history of malignancy within 5 years before the enrolment date with thefollowing exceptions:
In-situ carcinoma of the cervix where curative therapy has been completed andpatients 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 safetyof the patient
Study Design
Study Description
Connect with a study center
Research Site
Ansbach,
GermanyActive - Recruiting
Research Site
Auerbach,
GermanyActive - Recruiting
Research Site
Berlin,
GermanyActive - Recruiting
Research Site
Cottbus,
GermanyActive - Recruiting
Research Site
Darmstadt,
GermanyActive - Recruiting
Research Site
Dusseldorf,
GermanyActive - Recruiting
Research Site
Ehringshausen,
GermanyActive - Recruiting
Research Site
Frankfurt am Main,
GermanyActive - Recruiting
Research Site
Hamburg,
GermanyActive - Recruiting
Research Site
Heidelberg,
GermanyActive - Recruiting
Research Site
Itzehoe,
GermanyActive - Recruiting
Research Site
Jena,
GermanyActive - Recruiting
Research Site
Leipzig,
GermanyActive - Recruiting
Research Site
Lorrach,
GermanyActive - Recruiting
Research Site
Lubeck,
GermanyActive - Recruiting
Research Site
Markkleeberg,
GermanyActive - Recruiting
Research Site
Papenburg,
GermanyActive - Recruiting
Research Site
Rostock,
GermanyActive - Recruiting
Research Site
Saalfeld,
GermanyActive - Recruiting
Research Site
Weissenburg,
GermanyActive - Recruiting
Research Site
Wilhelmshaven,
GermanyActive - Recruiting
Research Site
Wurzburg,
GermanyActive - Recruiting
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