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

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AstraZeneca

Status

Active, not recruiting

Conditions

Severe Asthma

Study type

Observational

Funder types

Industry

Identifiers

NCT04221802
D3250R00059

Details and patient eligibility

About

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

Enrollment

76 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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:

  • 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.

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:

  • ≥30 days from last dose of previous biologic
  • Patients with other documented lung disease other than asthma and not within reimbursed label.

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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