Patient-reported Outcomes in Real-world Use of Benralizumab in Patients With Severe Eosinophilic Asthma in Belgium

NCT04221802 | Completed

• 1 other identifier: D3250R00059
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 10

Brief Summary

This study aims to assess health and quality of life outcomes in patients treated with benralizumab, within a Belgian Real-World setting. To prove the clinical value of benralizumab in a Real-World setting, the study will document the effect of benralizumab within a time frame of 112 weeks after initiation of treatment.

Conditions

Severe Asthma

Keywords

Severe asthma, benralizumab, real-world, observational

Outcome Measures

Primary Outcomes (1)

• change in patient-reported asthma related symptoms

  assessed with the Asthma Control Questionnaire (ACQ-6). The primary outcome variable (asthma control responder) is defined as a patient who had an at least (≥) 0.5-unit improvement in ACQ-6 score.

  up to 6 months after initiation of benralizumab

Secondary Outcomes (7)

• Change in patient-reported asthma related symptoms up to 112 weeks after initiation of benralizumab in a real-world setting

  up to 112 weeks after initiation of benralizumab

• change in daily OCS use following initiation of benralizumab in real-world setting

  up to 112 weeks after initiation of benralizumab

• change in asthma status in a real-world setting

  up to 112 weeks after initiation of benralizumab

• Rate of exacerbations after initiation of benralizumab in a real-world setting

  up to 112 weeks after initiation of benralizumab

• change of disease severity in a real-world setting

  up to 8 weeks after initiation of benralizumab

Other Outcomes (3)

• Improvement of nasal polyposis relevant health status

  up to 112 weeks after initiation of benralizumab

• Onset of effect of treatment

  up to 8 weeks after initiation of benralizumab

• safety and tolerability of benralizumab after initiation of benralizumab in real-world setting

  up to 112 weeks after initiation of benralizumab

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will enrol severe asthma patients who qualify for a treatment with benralizumab according to the label and Belgian reimbursement criteria and who have received reimbursement for treatment with benralizumab

You may qualify if:

• Male or female patients 18 years or older with physician's confirmed diagnosis of severe, uncontrolled asthma
• Asthma requiring high dose inhaled corticosteroid plus long-acting β adrenoceptor agonist as maintenance treatment
• A decreased lung function (FEV1 \<80%), demonstrated by spirometry in the 12 months before initiation of treatment
• Patients need to fulfil one of the criteria:
• at least 2 hospitalizations or ER treatments for severe asthma during last 12 months, or
• at least 2 asthma exacerbations during last 12 months (worsening of asthma with need of systemic corticotherapy for at least 3 days for non cortico-dependent patients, and/or an ER visit and or a hospitalization),
• or cortico-dependent (at least 6 months treatment with OCS at a daily dose of 4 mg or more of methylprednisolone or 5 mg or more of prednisolone for adults)
• Peripheral blood eosinophil count ≥300cells/μl at initiation of benralizumab treatment and in the year before.
• Obtained reimbursement for treatment with benralizumab
• Provision of signed written informed consent form (ICF) indicating that they understand the purpose of the study and procedures required for participation in the study.
• Patients must be able and willing to read and comprehend written instructions and comprehend and complete the questionnaires required by the protocol.
• Benralizumab naïve and have not previously received benralizumab prior to the start of this study.

You may not qualify if:

• Patients currently enrolled in an interventional clinical study in parallel (i.e. have not completed) including those with biologic treatment, will be excluded from the study except for patients who are in parallel documented in the Belgian Severe Asthma Registry (BSAR).
• 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
• Patients with other documented lung disease other than asthma and not within reimbursed label.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (10)

Research Site

Brussels, 1200, Belgium

Location

Research Site

Charleroi, 6042, Belgium

Location

Research Site

Edegem, 2650, Belgium

Location

Research Site

Erpent, 5101, Belgium

Location

Research Site

Kortrijk, 8500, Belgium

Location

Research Site

La Louvière, 7100, Belgium

Location

Research Site

Leuven, 3000, Belgium

Location

Research Site

Liège, 4000, Belgium

Location

Research Site

Mechelen, 2800, Belgium

Location

Research Site

Roeselare, 8800, Belgium

Location

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 Officials

• Dupont Lieve, Prof.

  Universitair Zienkenhuis Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2019
• First Posted: January 9, 2020
• Study Start: December 23, 2019
• Primary Completion: May 13, 2024
• Study Completion: May 13, 2024
• Last Updated: May 6, 2025

Record last verified: 2025-05

Locations

BE (10)