Severe Eosinophilic AsthmaBEEPSNCT03907137
Real World Study With Benralizumab in Severe Asthma in Switzerland
An observational study of Severe Eosinophilic Asthma, run by AstraZeneca at 12 sites in Switzerland.
Trial summary
BEEPS describes the utility of patient reported outcomes (PRO) as simple, pragmatic, and sensitive tool to assess early treatment response of benralizumab to document the level of asthma control and change in medication after 1 to 16 weeks post-treatment initiation including use of OCS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Eosinophilic Asthma
- How many people
- 79 participants
- Where
- 12 sitesSwitzerland
- Study dates
- 21 Jan 2019to 4 Jan 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will recruit 77 male and female patients aged ≥ 18 years with severe, eosinophilic asthma who meet all inclusion criteria and none of the exclusion criteria. Approximately 15-20 specialist centres across Switzerland will participate in the study which have experience with biologic treatment, can initiate treatment with benralizumab and have a good oversight on the severe asthma population, as in some settings the patients are referred for longer term stationary care to achieve asthma control.
Who may be able to join
- Subject eligible for enrolment in the study and treatment for benralizumab according to the specific Swiss label must meet all the following criteria:
- Male or female patients older than 18 years with physician's confirmed diagnosis of severe, uncontrolled asthma according to ATS/ERS guidelines.
- Asthma requiring high-dose ICS plus LABA as maintenance treatment.
- Minimum of 2 exacerbations in the last 12 months.
- Documented peripheral blood eosinophil count ≥ 300 cells/μL blood.
- 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 (ACQ-5, PGI-C and PGI-S).
Who cannot join
- Subjects meeting any of the following criteria will not be eligible to participate in the study:
- Documented lung diseases other than asthma, e.g. COPD, and not within reimbursed label, e.g pregnancy or lactation.
- Currently enrolled in an interventional clinical study in parallel, except:
- Patients being in parallel documented in a national asthma registry.
- Patients having completed any other clinical trial including those with biologic treatment.
- An acute or chronic condition that, in the investigator's opinion, would limit the patients' ability to complete questionnaires or participate in this study or impact the interpretations of results.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Switzerland12 sites
Research Site
Aathal, 8607
Research Site
Basel, 4031
Research Site
Bern, 3010
Research Site
Chur, 7000
Research Site
Geneva, 1211
Research Site
Liestal, 4410
Research Site
Lucerne, 6000
Research Site
Sion, 1950
Research Site
Wetzikon, 8620
Research Site
Zurich, 8006
Research Site
Zurich, 8032
Research Site
Zurich, 8044
About this study
Official title: Utilisation of Benralizumab in the Clinical Practise in Severe Eosinophilic Asthma Patients in Switzerland
BEEPS describes the utility of patient reported outcomes (PRO) as simple, pragmatic, and sensitive tool to assess early treatment response of benralizumab to document the level of asthma control and change in medication after 1 to 16 weeks post-treatment initiation including use of OCS. The generated data on the time of asthma symptom relief after initiation of benralizumab will support patient management for a better disease control in severe asthma patients under benralizumab treatment. To assess long term outcomes the patients will have a last mandatory visit after 56 weeks, with no visits scheduled between week 16 and 56.
Read the detailed description
The aim and objective of this single arm, prospective observational study is to describe patient reported outcomes (PRO) in severe eosinophilic asthma patients who are treated with benralizumab according to the label granted in Switzerland. The PRO measures consist of the weekly Asthma Control Questionnaire (ACQ-5) as well as Patient Global Impression of Change and Severity (PGI-C and PGI-S) collected at each visit (0, 1, 2, 4, 8, 16, 56 weeks). In addition the patient fills out twice daily the patient electronic asthma diary (eDiary) capturing daily symptoms and symptom free days together with a PEF (Peak Expiratory Flow) measurement. Persistance with eDiary and PEF will be assessed after 56 weeks. The percentage of patients successfully reducing their OCS dose will be evaluated after 16 weeks of treatment with benralizumab and if OCS reduction is persistent until week 56. Furthermore, the proportion of patients with an ACQ-5 score improvement of ≥ 0.5 after 8 weeks of treatment with benralizumab will be determined. In addition, the study will assess changes in FEV1 and FVC after 8, 16 and 56 weeks of treatment with benralizumab and describe retrospectively asthma disease history, past treatment status and current medication at baseline.
- Conditions
- Severe Eosinophilic Asthma
- Medical subject headings
- Pulmonary Eosinophilia
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline ACQ-5 score after 8 weeks after initiation of benralizumab
The ACQ-5 (Asthma Control Questionnaire - 5 questions) consists of 5 questions about the asthma symptoms in the last 7 days. Each question has a scale from 0 (no symptoms) to 6 (most severe). The reported mean score of all questions describes the level of asthma control (0-6) whereby a mean score >1,5 is considered as uncontrolled asthma.
Measured: 8 weeks
Secondary outcomes (8)
Percentage of patients on OCS who were able to reduce their OCS after 16 weeks.
In patients who take continuous oral corticosteroids (OCS) the fraction of patients who reduced the dosage of OCS is assessed. Daily oral OCS dosage in this patient group usually ranges from 2,5 to 40mg.
Measured: 16, 56 weeks
Change from baseline in ACQ 5 score up to 16 weeks after initiation of treatment with benralizumab.
The ACQ-5 (Asthma Control Questionnaire - 5 questions) consists of 5 questions about the asthma symptoms in the last 7 days. Each question has a scale from 0 (no symptoms) to 6 (most severe). The reported mean score of all questions describes the level of asthma control (0-6) whereby a mean score >1,5 is considered as uncontrolled asthma.
Measured: 1, 2, 4, 16, 56 weeks
Proportion of patients with a total score improvement of ≥ 0.5 in ACQ-5 under treatment with benralizumab.
The ACQ-5 (Asthma Control Questionnaire - 5 questions) consists of 5 questions about the asthma symptoms in the last 7 days. Each question has a scale from 0 (no symptoms) to 6 (most severe). The reported mean score of all questions describes the level of asthma control (0-6) whereby a mean score >1,5 is considered as uncontrolled asthma.
Measured: 1,2,4,8,16,56 weeks
Change from baseline in PGI-C in asthma.
The Patient Global Impression of Change (PGI-C) rates the patients general impression of his asthma health status since study start on a scale from 1 to 7. 1 meaning much better, 4 equal and 7 much worse.
Measured: 1, 2, 4, 8, 16, 56 weeks
Change from baseline in PGI-S in asthma
The Patient Global Impression of Severity (PGI-S) rates the current asthma status on a scale from 1 to 6. 1 meaning no symptoms and 6 meaning very heavy symptoms.
Measured: 1, 2, 4, 8, 16, 56 weeks
Asthma disease history
The time and age of first asthma diagnosis, the presence of allergic cofactors and the history of exacerbations in the last 12 month since study start will be recorded.
Measured: Baseline
Past treatment status
Prescribed medication for Astma in the last 12 month before study enrollment will be recorded. Special emphasis will be put on inhallation therapy and OCS use and any changes. Any previous biological therapy will be recorded as well.
Measured: Baseline
Patient demographics
Age (Years), sex (m/f), weight (kg) and height (cm) will be recorded
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study start21 Jan 2019
- Primary completion4 Jan 2023
- Study completion4 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Eosinophilic 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
- Other
- Time perspective
- Prospective
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Rothe, Dr. med., Principal investigator, Kantonsspital Graubünden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03907137
- Sponsor's protocol ID
- D3250R00048
- Acronym
- BEEPS
- Status last verified
- Feb 2024
- First submitted
- 14 Mar 2019
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilisation of Benralizumab in the Clinical Practise in Severe Eosinophilic Asthma Patients in Switzerland
- ClinicalTrials.gov ID
- NCT03907137
- Acronym / sponsor ID
- BEEPS / D3250R00048
- Conditions
- Severe Eosinophilic Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 21 Jan 2019 (actual)
- Primary completion
- 4 Jan 2023 (actual)
- Study completion
- 4 Jan 2023 (actual)
- First posted
- 8 Apr 2019 (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.
BEEPS describes the utility of patient reported outcomes (PRO) as simple, pragmatic, and sensitive tool to assess early treatment response of benralizumab to document the level of asthma control and change in medication after 1 to 16 weeks post-treatment initiation including use of OCS. The generated data on the time of asthma symptom relief after initiation of benralizumab will support patient management for a better disease control in severe asthma patients under benralizumab treatment. To assess long term outcomes the patients will have a last mandatory visit after 56 weeks, with no visits scheduled between week 16 and 56.
Detailed description
The aim and objective of this single arm, prospective observational study is to describe patient reported outcomes (PRO) in severe eosinophilic asthma patients who are treated with benralizumab according to the label granted in Switzerland. The PRO measures consist of the weekly Asthma Control Questionnaire (ACQ-5) as well as Patient Global Impression of Change and Severity (PGI-C and PGI-S) collected at each visit (0, 1, 2, 4, 8, 16, 56 weeks). In addition the patient fills out twice daily the patient electronic asthma diary (eDiary) capturing daily symptoms and symptom free days together with a PEF (Peak Expiratory Flow) measurement. Persistance with eDiary and PEF will be assessed after 56 weeks. The percentage of patients successfully reducing their OCS dose will be evaluated after 16 weeks of treatment with benralizumab and if OCS reduction is persistent until week 56. Furthermore, the proportion of patients with an ACQ-5 score improvement of ≥ 0.5 after 8 weeks of treatment with benralizumab will be determined. In addition, the study will assess changes in FEV1 and FVC after 8, 16 and 56 weeks of treatment with benralizumab and describe retrospectively asthma disease history, past treatment status and current medication at baseline.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will recruit 77 male and female patients aged ≥ 18 years with severe, eosinophilic asthma who meet all inclusion criteria and none of the exclusion criteria. Approximately 15-20 specialist centres across Switzerland will participate in the study which have experience with biologic treatment, can initiate treatment with benralizumab and have a good oversight on the severe asthma population, as in some settings the patients are referred for longer term stationary care to achieve asthma control.
Key inclusion criteria (7 listed)
- Subject eligible for enrolment in the study and treatment for benralizumab according to the specific Swiss label must meet all the following criteria:
- Male or female patients older than 18 years with physician's confirmed diagnosis of severe, uncontrolled asthma according to ATS/ERS guidelines.
- Asthma requiring high-dose ICS plus LABA as maintenance treatment.
- Minimum of 2 exacerbations in the last 12 months.
- Documented peripheral blood eosinophil count ≥ 300 cells/μL blood.
Key exclusion criteria (6 listed)
- Subjects meeting any of the following criteria will not be eligible to participate in the study:
- Documented lung diseases other than asthma, e.g. COPD, and not within reimbursed label, e.g pregnancy or lactation.
- Currently enrolled in an interventional clinical study in parallel, except:
- An acute or chronic condition that, in the investigator's opinion, would limit the patients' ability to complete questionnaires or participate in this study or impact the interpretations of results.
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 from baseline ACQ-5 score after 8 weeks after initiation of benralizumab
Time frame: 8 weeks
The ACQ-5 (Asthma Control Questionnaire - 5 questions) consists of 5 questions about the asthma symptoms in the last 7 days. Each question has a scale from 0 (no symptoms) to 6 (most severe). The reported mean score of all questions describes the level of asthma control (0-6) whereby a mean score >1,5 is considered as uncontrolled asthma.
8 secondary outcomes
Percentage of patients on OCS who were able to reduce their OCS after 16 weeks.
Time frame: 16, 56 weeks
Change from baseline in ACQ 5 score up to 16 weeks after initiation of treatment with benralizumab.
Time frame: 1, 2, 4, 16, 56 weeks
Proportion of patients with a total score improvement of ≥ 0.5 in ACQ-5 under treatment with benralizumab.
Time frame: 1,2,4,8,16,56 weeks
Change from baseline in PGI-C in asthma.
Time frame: 1, 2, 4, 8, 16, 56 weeks
Change from baseline in PGI-S in asthma
Time frame: 1, 2, 4, 8, 16, 56 weeks
Asthma disease history
Time frame: Baseline
Past treatment status
Time frame: Baseline
Patient demographics
Time frame: Baseline
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 29 Feb 2024.
- D3250R00048\_BEEPS\_CSR\_Synopsis\_022024\_Redacted.pdfLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Thomas Rothe, Dr. med. principal investigator
Kantonsspital Graubünden
12 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 Eosinophilic Asthma, run by AstraZeneca at 12 sites in Switzerland.
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 7 inclusion and 6 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 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Switzerland. 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 from baseline ACQ-5 score after 8 weeks after initiation of benralizumab (time frame: 8 weeks). 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 29 Feb 2024.