Severe AsthmaBE-REALNCT04221802
Patient-reported Outcomes in Real-world Use of Benralizumab in Patients With Severe Eosinophilic Asthma in Belgium
An observational study of Severe Asthma, run by AstraZeneca at 10 sites in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Severe Asthma
- How many people
- 76 participants
- Where
- 10 sitesBelgium
- Study dates
- 23 Dec 2019to 13 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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),
Show all 12Show fewer
- 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.
Who cannot join
- 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 locations and contacts
10 sites in 1 country.
10 sites in 1 country
Belgium10 sites
Research Site
Brussels, 1200
Research Site
Charleroi, 6042
Research Site
Edegem, 2650
Research Site
Erpent, 5101
Research Site
Kortrijk, 8500
Research Site
La Louvière, 7100
Research Site
Leuven, 3000
Research Site
Liège, 4000
Research Site
Mechelen, 2800
Research Site
Roeselare, 8800
About this study
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
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.
Read the 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
- Conditions
- Severe Asthma
- Keywords
- Severe asthma, benralizumab, real-world, observational
- Medical subject headings
- Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
change in patient-reported asthma related symptoms
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.
Measured: up to 6 months after initiation of benralizumab
Secondary outcomes (7)
Change in patient-reported asthma related symptoms up to 112 weeks after initiation of benralizumab in a real-world setting
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.
Measured: up to 112 weeks after initiation of benralizumab
change in daily OCS use following initiation of benralizumab in real-world setting
Percent change from baseline daily OCS dose
Measured: up to 112 weeks after initiation of benralizumab
change in asthma status in a real-world setting
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
Measured: up to 112 weeks after initiation of benralizumab
Rate of exacerbations after initiation of benralizumab in a real-world setting
assessed with the Number of exacerbations
Measured: up to 112 weeks after initiation of benralizumab
change of disease severity in a real-world setting
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.
Measured: up to 8 weeks after initiation of benralizumab
Healthcare resource utilization in a real-world setting
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.
Measured: up to 112 weeks after initiation of benralizumab
change in treatment satisfaction in a real-world setting
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.
Measured: up to 112 weeks after initiation of benralizumab
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2020
- Study start23 Dec 2019
- Primary completion13 May 2024
- Study completion13 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dupont Lieve, Prof., Principal investigator, Universitair Zienkenhuis Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04221802
- Sponsor's protocol ID
- D3250R00059
- Acronym
- BE-REAL
- Status last verified
- May 2025
- First submitted
- 5 Dec 2019
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04221802
- Acronym / sponsor ID
- BE-REAL / D3250R00059
- Conditions
- Severe Asthma
- Keywords
- Severe asthma, benralizumab, real-world, observational
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 23 Dec 2019 (actual)
- Primary completion
- 13 May 2024 (actual)
- Study completion
- 13 May 2024 (actual)
- First posted
- 9 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
7 secondary outcomes
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
change in daily OCS use following initiation of benralizumab in real-world setting
Time frame: up to 112 weeks after initiation of benralizumab
change in asthma status in a real-world setting
Time frame: up to 112 weeks after initiation of benralizumab
Rate of exacerbations after initiation of benralizumab in a real-world setting
Time frame: up to 112 weeks after initiation of benralizumab
change of disease severity in a real-world setting
Time frame: up to 8 weeks after initiation of benralizumab
Healthcare resource utilization in a real-world setting
Time frame: up to 112 weeks after initiation of benralizumab
change in treatment satisfaction in a real-world setting
Time frame: up to 112 weeks after initiation of benralizumab
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- CSR SynopsisLink provided by the sponsor.
Related trials for Severe Asthma
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
RecruitingPhase 2
A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma
Asthma
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig ( PF-07275315) in People With Severe Asthma
Asthma
RecruitingPhase 3
Phase 3b Study in Patients With Severe Asthma Treated With Tezepelumab
Severe Asthma
Active, not recruitingPhase 3
A Study to Test if a Fixed-Dose Combination of Fluticasone Propionate/Albuterol Sulfate is Effective in Preventing Asthma Exacerbations
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dupont Lieve, Prof. principal investigator
Universitair Zienkenhuis Leuven
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Asthma, run by AstraZeneca at 10 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in patient-reported asthma related symptoms (time frame: up to 6 months after initiation of benralizumab). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025.