Clinical trial NCT04221802: Patient-reported Outcomes in Real-world Use of Benralizumab in Patients With Severe Eosinophilic Asthma in Belgium
Official title: A Multicentre Single Arm Observational Prospective Study to Assess Demographic Characteristics Burden of Disease PRO's in Uncontrolled, Severe Eosinophilic Asthma Patients Aged 18y or Older and Qualifying for Treatment With Benralizumab in BE
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Asthma
Keywords: Severe asthma, benralizumab, real-world, observational
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2020-01-09
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.

Detailed 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

Eligibility criteria: 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.

Primary outcomes:
measure: change in patient-reported asthma related symptoms
timeFrame: up to 6 months after initiation of benralizumab
Secondary outcomes:
measure: Change in patient-reported asthma related symptoms up to 112 weeks after initiation of benralizumab in a real-world setting
timeFrame: up to 112 weeks after initiation of benralizumab
measure: change in daily OCS use following initiation of benralizumab in real-world setting
timeFrame: up to 112 weeks after initiation of benralizumab
measure: change in asthma status in a real-world setting
timeFrame: up to 112 weeks after initiation of benralizumab
measure: Rate of exacerbations after initiation of benralizumab in a real-world setting
timeFrame: up to 112 weeks after initiation of benralizumab
measure: change of disease severity in a real-world setting
timeFrame: up to 8 weeks after initiation of benralizumab
measure: Healthcare resource utilization in a real-world setting
timeFrame: up to 112 weeks after initiation of benralizumab
measure: change in treatment satisfaction in a real-world setting
timeFrame: up to 112 weeks after initiation of benralizumab
Other outcomes:
measure: Improvement of nasal polyposis relevant health status
timeFrame: up to 112 weeks after initiation of benralizumab
measure: Onset of effect of treatment
timeFrame: up to 8 weeks after initiation of benralizumab
measure: safety and tolerability of benralizumab after initiation of benralizumab in real-world setting
timeFrame: up to 112 weeks after initiation of benralizumab
Locations:
city: Bruxelles
country: Belgium
facility: Research Site
city: Charleroi
country: Belgium
facility: Research Site
city: Edegem
country: Belgium
facility: Research Site
city: Erpent
country: Belgium
facility: Research Site
city: Kortrijk
country: Belgium
facility: Research Site
city: La Louviere
country: Belgium
facility: Research Site
city: Leuven
country: Belgium
facility: Research Site
city: Liege
country: Belgium
facility: Research Site
city: Mechelen
country: Belgium
facility: Research Site
city: Roeselare
country: Belgium
facility: Research Site
Study officials:
affiliation: Universitair Zienkenhuis Leuven
name: Dupont Lieve, Prof.
role: PRINCIPAL_INVESTIGATOR
References: