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

Status: Recruiting
Location: See all (34) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 120
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
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Ahrensburg
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Ansbach
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Auerbach
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Bad Homburg
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Berlin
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Cottbus
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Darmstadt
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Düsseldorf
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Ehringshausen
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Essen
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Flensburg
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Frankfurt Am Main
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Halle
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Hamburg
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Hanover
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Heidelberg
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Hohenstein-ernsttahl
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Itzehoe
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Jena
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Leipzig
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Loerrach
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Lübeck
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Lüneburg
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Markkleeberg
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Neuruppin
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Nuremberg
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Papenburg
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Rostock
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Saalfeld
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Spardorf
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Weißenburg
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Wilhelmshaven
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Würzburg
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Zossen
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2024-07-25
Estimated Completion Date: 2027-07-31
Participants
Target number of participants: 300
Related Therapeutic Areas
Sponsors
Leads: AstraZeneca

This content was sourced from clinicaltrials.gov