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

  • STATUS
    Recruiting
  • participants needed
    150
  • sponsor
    AstraZeneca
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Updated on 16 February 2024
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corticosteroids
asthma
eosinophil count
benralizumab
lung function
decreased lung function

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 56 weeks after initiation of treatment.

Description

The aim and objective of this single arm, prospective observational study is to provide supporting RWE on the symptom relief of asthma patients qualified for benralizumab therapy in Belgium. The PRO measures consist of the Asthma Control Questionnaire (ACQ 6) as well as Patient Global Impression of Change and Severity (PGI-C and PGI-S), healthcare resource utilization (HCRU) and treatment satisfaction (TSQM-9). In addition change in daily OCS use and rate of exacerbations after initiation of benralizumab in real-world setting will be assessed

Details
Condition Severe Asthma
Age 18years - 99years
Clinical Study IdentifierNCT04221802
SponsorAstraZeneca
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

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 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/l 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 nave and have not previously received benralizumab prior to the start of this study

Exclusion Criteria

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
days from last dose of previous biologic
Patients with other documented lung disease other than asthma and not within reimbursed label
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