Change in Patient-Reported Outcomes in Severe Eosinophilic Asthma Patients Treated With Benralizumab Under Real-life Conditions

NCT ID: NCT04184284

Last Updated: 2024-12-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 246 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-11-15
• Study Completion Date: 2023-12-19

Brief Summary

The main aim of this study is to investigate the change in asthma control after 6 months of therapy in patients treated with benralizumab biologic therapy for severe eosinophilic asthma under real-life conditions in a pulmonary care setting in Germany. The study also aims to investigate Quality-of-Life (QoL), the early treatment response, treatment effectiveness and the change in asthma control over time, following benralizumab therapy. This study will also describe the physician-chosen reasons for starting beralizumab therapy or switching to benralizumab therapy.

Conditions

Asthma

Keywords

benralizumab

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Primary Study Cohort - Anti-IL5/IL5R naïve patients

Severe eosinophilic asthma patients who have never received anti-Interleukin-5 / anti-Interleukin-5-receptor (anti-IL-5/anti-IL-5R) biologic treatment for severe eosinophilic asthma, for whom the investigator had decided to initiate benralizumab biologic treatment.

No interventions assigned to this group

Secondary Study Cohort - Biologic experienced patients

Patients that previously received a biologic treatment for severe asthma (at least one dose).

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Male or female patients aged 18 years or older with confirmed diagnosis of severe asthma according to the ATS/ERS and local German guidelines
• Decision was made by the investigator (regardless of this NIS) to start treating the patient with benralizumab according to severe eosinophilic asthma indication (NB: can include patients that are switched from another EU approved biologic treatment if required for a medical reason).
• Patients must be able and willing to read and comprehend written instructions, and comprehend and complete the questionnaires required by the protocol
• After full explanation, patients must have signed an informed consent document indicating that they understand the purpose of and the procedures required for the study and are willing to participate in the study.

Exclusion Criteria

• Concomitant treatment with any other biologic for any indication
• Patients already treated with benralizumab
• Clinically important pulmonary disease other than asthma including: chronic obstructive pulmonary disease (as main diagnosis), bronchiectasis, idiopathic pulmonary fibrosis, pulmonary hypertension, alpha-1-antitrypsin-deficiency, and malignancy of any kind (NB: the following conditions are permitted: nasal polyposis, allergic rhinitis, atopic dermatitis, non-idiopathic pulmonary fibrosis).
• An acute or chronic condition that, in the investigator's opinion, would limit the patient's ability to complete questionnaires or participate in this study or impact the interpretations of results.
• Concurrent biologics for asthma are not allowed except for stable allergen immunotherapy (defined as a stable dose and regimen at the time of enrolment). Acceptable wash-out periods for other asthma biologics: ≥30 days from last dose of previous biologic
• Pregnancy or lactation period
• Participation in an observational trial that might, in the investigator's opinion, influence the assessment for the current study, or participation in a randomized clinical trial in the last 3 months

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Research Site

Aschaffenburg, , Germany

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Augsburg, , Germany

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Bamberg, , Germany

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Beelitz, , Germany

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Berlin, , Germany

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Biberach, , Germany

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Bonn, , Germany

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Bremen, , 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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Flensburg, , Germany

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Frankfurt, , Germany

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Fürstenwalde, , Germany

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Gelsenkirchen, , Germany

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Gerlingen, , Germany

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Gotingen, , Germany

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Halberstadt, , 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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Hemer, , Germany

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Hettstedt, , Germany

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Ibbenbueren, , Germany

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Immenhausen, , Germany

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Konstanz, , Germany

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Leipzig, , Germany

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Magdeburg, , Germany

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Marburg, , Germany

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Markkleeberg, , Germany

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München, , Germany

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Neu-Isenburg, , Germany

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Peine, , Germany

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Radebeul, , Germany

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Regensburg, , Germany

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Reinfeld, , Germany

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Rheine, , Germany

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Rostock, , Germany

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Roth, , Germany

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Saalfeld, , Germany

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Schleswig, , Germany

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Teuchern, , Germany

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Treuenbrietzen, , Germany

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Waren, , Germany

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Warendorf, , Germany

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Wedel, , Germany

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Wiesbaden, , Germany

Research Site

Witten, , Germany

Countries

Germany

Related Links

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D3250R00053&attachmentIdentifier=9e610f4f-74eb-4fa3-9d76-16af3879d0a4&fileName=D3250R00053_imPROve_CSR-Synopsis_V1.0_ctt_redacted.pdf&versionIdentifier=

CSR Synopsis

Other Identifiers

D3250R00053

Identifier Type: -

Identifier Source: org_study_id