- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04221802
Patient-reported Outcomes in Real-world Use of Benralizumab in Patients With Severe Eosinophilic Asthma in Belgium (BE-REAL)
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 Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Bruxelles, Belgium, 1200
- Research Site
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Charleroi, Belgium, 6042
- Research Site
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Edegem, Belgium, 2650
- Research Site
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Erpent, Belgium, 5101
- Research Site
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Kortrijk, Belgium, 8500
- Research Site
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La Louviere, Belgium, 7100
- Research Site
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Leuven, Belgium, 3000
- Research Site
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Liege, Belgium, 4000
- Research Site
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Mechelen, Belgium, 2800
- Research Site
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Roeselare, Belgium, 8800
- Research Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in patient-reported asthma related symptoms
Time Frame: up to 6 months after initiation of benralizumab
|
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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in patient-reported asthma related symptoms up to 112 weeks after initiation of benralizumab in a real-world setting
Time Frame: up to 112 weeks after initiation of benralizumab
|
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 112 weeks after initiation of benralizumab
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change in daily OCS use following initiation of benralizumab in real-world setting
Time Frame: up to 112 weeks after initiation of benralizumab
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Percent change from baseline daily OCS dose
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up to 112 weeks after initiation of benralizumab
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change in asthma status in a real-world setting
Time Frame: up to 112 weeks after initiation of benralizumab
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assessed with the Global Impression of Severity (PGI-S). The PGI-S score will be categorized according to the following responses post-baseline: very mild, mild, moderate, severe or very severe. PGI-S at baseline, week 2, 4, 8, 24, 56, 80 and 112 will be presented descriptively |
up to 112 weeks after initiation of benralizumab
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Rate of exacerbations after initiation of benralizumab in a real-world setting
Time Frame: up to 112 weeks after initiation of benralizumab
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assessed with the Number of exacerbations
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up to 112 weeks after initiation of benralizumab
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change of disease severity in a real-world setting
Time Frame: up to 8 weeks after initiation of benralizumab
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Assessed with the Global Impression of Change (PGI-C). The PGI-C score will be categorized according to the following responses post-baseline: much better; moderately better; a little better; about the same; a little worse; moderately worse; and much worse. PGI-C responder endpoint (a little better, moderately better, much better) will be summarised by visit for patients. |
up to 8 weeks after initiation of benralizumab
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Healthcare resource utilization in a real-world setting
Time Frame: up to 112 weeks after initiation of benralizumab
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assessed with the Health Care Resource Utilization Questionnaire (HCRU).
The HCRU will assess number of asthma-related ED/hospital admissions, number of visits to primary care physician or specialist, number of home visits by health care professional, number of pharmacy visits and number of work/school days lost due to asthma.
|
up to 112 weeks after initiation of benralizumab
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change in treatment satisfaction in a real-world setting
Time Frame: up to 112 weeks after initiation of benralizumab
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assessed with the Treatment Satisfaction Questionnaire for Medication (TSQM-9). The TSQM-9 domain scores range from 0 to 100 with higher scores representing higher satisfaction on that domain. The TSQM-9 scores will be presented descriptively by domain with a focus on efficacy and satisfaction. |
up to 112 weeks after initiation of benralizumab
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement of nasal polyposis relevant health status
Time Frame: up to 112 weeks after initiation of benralizumab
|
Nasal polyposis symptoms and sense of smell will be scored on a visual analogue scale (VAS) ranging from 0 to 10 in how bothersome they were in the past month (at baseline) or versus last visit (for all other timepoints) with 0 being not at all bothersome and 10 being extremely bothersome. The improvement of nasal polyposis relevant health status (symptoms and sense of smell) will be presented descriptively. |
up to 112 weeks after initiation of benralizumab
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Onset of effect of treatment
Time Frame: up to 8 weeks after initiation of benralizumab
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Assessed with one question up to what extent they agree or disagree that, during the past week, they could tell their medication was working. Answers range from strongly agree to strongly disagree. Patient experience of onset of effect of treatment will be presented descriptively |
up to 8 weeks after initiation of benralizumab
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safety and tolerability of benralizumab after initiation of benralizumab in real-world setting
Time Frame: up to 112 weeks after initiation of benralizumab
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The incidence of AEs: The total number of AEs/SAEs per patient, as well as the proportion of patients with at least one AE/SAE will be summarised
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up to 112 weeks after initiation of benralizumab
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dupont Lieve, Prof., Universitair Zienkenhuis Leuven
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D3250R00059
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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