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

NCT04184284 | Completed

• 1 other identifier: D3250R00053
• Study Type: observational
• Target: 246
• Locations: 1 country
• Sites: 50

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

Outcome Measures

Primary Outcomes (1)

• The change in asthma control after 6 months of treatment in anti-IL5/IL5R naïve patients initiated with benralizumab treatment

  Change from baseline in (Asthma Control Test - questionnaire) ACT score after 6 months treatment in anti-IL5/IL5R naïve patients. ACT is a simple, validated, 5-item tool giving a total score from 5 (worst control) to 25 (best control). Scores of 20 to 25 denote well-controlled asthma, scores ≤19 identifies patients with poorly controlled asthma. The minimum clinically important difference (MCID) is reported to be 3 points.

  Baseline and 6 months after baseline

Secondary Outcomes (11)

• The investigator reported treatment effectiveness after 6 months of treatment in anti-IL5/IL5R naïve patients initiated with benralizumab treatment

  6 months after first treatment

• The change in health-related quality of life (HRQL) in anti-IL5/IL5R naïve patients initiated with benralizumab treatment

  Baseline and 6 months after first treatment

• The early treatment response in anti-IL5/IL5R naïve patients initiated with benralizumab treatment, day 7, ACQ-6

  Baseline and day 7 after first treatment

• The early treatment response in anti-IL5/IL5R naïve patients initiated with benralizumab treatment, day 7, VAS-1

  Baseline and day 7 after first treatment

• The early treatment response in anti-IL5/IL5R naïve patients initiated with benralizumab treatment, day 7, VAS-2

  Baseline and day 7 after first treatment

Other Outcomes (8)

• The change of physical activity over time in anti-IL5/IL5R naïve patients

  Baseline until end of follow-up (approx. 24 months after enrollment)

• The change in asthma control after 6, 12, 18 and 24 months of treatment in biologic experienced patients, using ACT

  Baseline, 6, 12, 18 and 24 months after first treatment

• The change in asthma control and the maintained response after initiation of benralizumab treatment in biologic experienced patients using ACQ-6

  Baseline, 6, 12, 18 and 24 months after first treatment

Study Arms (2)

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.

Secondary Study Cohort - Biologic experienced patients

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

approximately 350 to 500 patients in 70 pulmonology sites (hospitals and outpatient practices) in Germany Primary study cohort: approximately 250 patients Secondary study cohort: approximately 100 to 250 patients

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (50)

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

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Witten, Germany

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Related Links

• CSR Synopsis

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2019
• First Posted: December 3, 2019
• Study Start: November 15, 2019
• Primary Completion: December 19, 2023
• Study Completion: December 19, 2023
• Last Updated: December 9, 2024

Record last verified: 2024-12

Locations

DE (50)