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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.
Full 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
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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 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:
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.
Exclusion criteria
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Data sourced from clinicaltrials.gov
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