Severe Eosinophilic AsthmaNCT05271526
Real World Evidence of Benralizumab in Eosinophilic Severe AsThma in Russia (BEST)
An observational study of Severe Eosinophilic Asthma, run by AstraZeneca at 1 site in Russia.
Trial summary
Benralizumab is a humanised, afucosylated, monoclonal antibody against the interleukin (IL)-5 receptor (IL-5R) α subunit that induces direct, rapid, and near-complete depletion of eosinophils in blood, airway tissue, and bone marrow through enhanced antibody-dependent cell-mediated cytotoxicity (ADCC). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Severe Eosinophilic Asthma
- How many people
- 3 participants
- Where
- 1 siteRussia
- Study dates
- 16 May 2022to 13 Nov 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study will recruit 59 male and female patients aged ≥ 18 years with severe, eosinophilic asthma who meet all inclusion criteria and none of the exclusion criteria (15% drop out). Approximately 10 centers across Russia will participate in the study. Only those centres that 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) will be able to participate.
Who may be able to join
- Subject eligible for enrolment in the study and treatment for benralizumab according to the specific Russian label and in line with reimbursement condition must meet all the following criteria:
- Male or female patients older than 18 years with physician's confirmed diagnosis of severe, uncontrolled asthma.
- Asthma requiring high-dose ICS plus LABA as maintenance treatment.
- Minimum of 2 exacerbations in the last 12 months. Or 1 exacerbation in case that patient had been receiving oral glucocorticoid therapy for at least 6 continuous months directly before enrollment (equivalent to a prednisolone or prednisone dose of 7.5 to 40.0 mg per day)
- Documented peripheral blood eosinophil count ≥ 300 cells/μL or ≥150 cells/μL blood in case that patient had been receiving oral glucocorticoid therapy for at least 6 continuous months directly before enrollment (equivalent to a prednisolone or prednisone dose of 7.5 to 40.0 mg per day).
- Provision of signed written 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 (SGRQ, ACQ-5, PGIC and PGIS).
Who cannot join
- Patients who have previously received benralizumab prior to the start of the study.
- Documented lung diseases other than asthma, e.g. COPD, and not within reimbursed label, e.g pregnancy or lactation.
- Concomitant treatment with any other biologic for any indication or previous treatment with biology. Acceptable wash-out periods for other asthma biologics: ≥4 month or duration of 5 half-lives from last dose of previous biologic. We choose what is longer the 5 half-life or 4 months.
- 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 ≥4 month or duration of 5 half-lives from last dose of previous biologic. We choose what is longer the 5 half-life or 4 months.
- 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
1 site in 1 country.
About this study
Official title: A Multicenter, Single Arm, Non-interventional, Observational, Prospective Study to Assess Demographic Characteristics, Burden of Disease and Short-term Patient Reported Outcomes on Symptom Relief in Severe Eosinophilic Asthma Patients Aged Older Than 18 Qualifying for Treatment With Benralizumab in Russia
Benralizumab is a humanised, afucosylated, monoclonal antibody against the interleukin (IL)-5 receptor (IL-5R) α subunit that induces direct, rapid, and near-complete depletion of eosinophils in blood, airway tissue, and bone marrow through enhanced antibody-dependent cell-mediated cytotoxicity (ADCC). This apoptotic process involves natural killer cells responsible for the controlled eosinophilic elimination. In the two pivotal phase III trials SIROCCO and CALIMA, benralizumab was well tolerated, significantly reduced asthma exacerbations by up to 51%, and improved lung function as well as disease control in patients with severe, uncontrolled asthma and blood eosinophil count of ≥ 300 cells/μL blood, receiving both ICS and LABA.
According to the summary of product's characteristics (SmPC) of benralizumab in Russia, it can be used for an add-on maintenance treatment for adult patients with severe eosinophilic asthma. All patients enrolled in the BEST study will comply with the SmPC approved by the Russian Ministry of Health.
Read the detailed description
This is a multicentre, single arm, non-interventional observational, prospective study that will include patients older than 18 years, who qualify for the treatment with benralizumab according to the SmPC in participating research centres (study cites) focusing on severe eosinophilic asthma in Russia. The decision by the physician to start benralizumab is made independently from study inclusion and patient informed consent. Patients who meet the study criteria will be enrolled and, as outlined in the current label of benralizumab approved by Russian Ministry of Health, are planned to receive 3 subcutaneously (s.c.) applied doses of 30 mg benralizumab, from weeks 0 (baseline) every 4 weeks and then every 8 week. A follow-up visit to assess the sustainability of achieved changes will be done after 56 weeks. No study drug will be provided, all patients will be on commercially available drug. Additional two study visits at week 1 and 2 can also be done remotely via phone calls to obtain the paper-based SGRQ, ACQ-5, PGI-C and PGI-S questionnaires.
- 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.
To evaluate the change in patient asthma control after initiation of benralizumab in a real-world Russian setting
Mean scores change from baseline in Asthma Control Questionnaire-5 (ACQ-5) after 8 weeks of treatment with benralizumab.
Measured: Up to 6 month
To evaluate the change in respiratory health-related quality of life in a real-world Russian setting
Total scores change from baseline in St. George's Respiratory Questionnaire (SGRQ) after 8 weeks of treatment with benralizumab
Measured: Up to 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start16 May 2022
- Primary completion13 Nov 2023
- Study completion13 Nov 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05271526
- Sponsor's protocol ID
- D3250R00101
- Status last verified
- Oct 2024
- First submitted
- 28 Feb 2022
- Last updated
- 21 Oct 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single Arm, Non-interventional, Observational, Prospective Study to Assess Demographic Characteristics, Burden of Disease and Short-term Patient Reported Outcomes on Symptom Relief in Severe Eosinophilic Asthma Patients Aged Older Than 18 Qualifying for Treatment With Benralizumab in Russia
- ClinicalTrials.gov ID
- NCT05271526
- Acronym / sponsor ID
- D3250R00101
- Conditions
- Severe Eosinophilic Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 16 May 2022 (actual)
- Primary completion
- 13 Nov 2023 (actual)
- Study completion
- 13 Nov 2023 (actual)
- First posted
- 9 Mar 2022 (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.
Benralizumab is a humanised, afucosylated, monoclonal antibody against the interleukin (IL)-5 receptor (IL-5R) α subunit that induces direct, rapid, and near-complete depletion of eosinophils in blood, airway tissue, and bone marrow through enhanced antibody-dependent cell-mediated cytotoxicity (ADCC). This apoptotic process involves natural killer cells responsible for the controlled eosinophilic elimination. In the two pivotal phase III trials SIROCCO and CALIMA, benralizumab was well tolerated, significantly reduced asthma exacerbations by up to 51%, and improved lung function as well as disease control in patients with severe, uncontrolled asthma and blood eosinophil count of ≥ 300 cells/μL blood, receiving both ICS and LABA.
According to the summary of product's characteristics (SmPC) of benralizumab in Russia, it can be used for an add-on maintenance treatment for adult patients with severe eosinophilic asthma. All patients enrolled in the BEST study will comply with the SmPC approved by the Russian Ministry of Health.
Detailed description
This is a multicentre, single arm, non-interventional observational, prospective study that will include patients older than 18 years, who qualify for the treatment with benralizumab according to the SmPC in participating research centres (study cites) focusing on severe eosinophilic asthma in Russia. The decision by the physician to start benralizumab is made independently from study inclusion and patient informed consent. Patients who meet the study criteria will be enrolled and, as outlined in the current label of benralizumab approved by Russian Ministry of Health, are planned to receive 3 subcutaneously (s.c.) applied doses of 30 mg benralizumab, from weeks 0 (baseline) every 4 weeks and then every 8 week. A follow-up visit to assess the sustainability of achieved changes will be done after 56 weeks. No study drug will be provided, all patients will be on commercially available drug. Additional two study visits at week 1 and 2 can also be done remotely via phone calls to obtain the paper-based SGRQ, ACQ-5, PGI-C and PGI-S questionnaires.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study will recruit 59 male and female patients aged ≥ 18 years with severe, eosinophilic asthma who meet all inclusion criteria and none of the exclusion criteria (15% drop out). Approximately 10 centers across Russia will participate in the study. Only those centres that 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) will be able to participate.
Key inclusion criteria (7 listed)
- Subject eligible for enrolment in the study and treatment for benralizumab according to the specific Russian label and in line with reimbursement condition must meet all the following criteria:
- Male or female patients older than 18 years with physician's confirmed diagnosis of severe, uncontrolled asthma.
- Asthma requiring high-dose ICS plus LABA as maintenance treatment.
- Minimum of 2 exacerbations in the last 12 months. Or 1 exacerbation in case that patient had been receiving oral glucocorticoid therapy for at least 6 continuous months directly before enrollment (equivalent to a prednisolone or prednisone dose of 7.5 to 40.0 mg per day)
- Documented peripheral blood eosinophil count ≥ 300 cells/μL or ≥150 cells/μL blood in case that patient had been receiving oral glucocorticoid therapy for at least 6 continuous months directly before enrollment (equivalent to a prednisolone or prednisone dose of 7.5 to 40.0 mg per day).
Key exclusion criteria (7 listed)
- Patients who have previously received benralizumab prior to the start of the study.
- Documented lung diseases other than asthma, e.g. COPD, and not within reimbursed label, e.g pregnancy or lactation.
- Concomitant treatment with any other biologic for any indication or previous treatment with biology. Acceptable wash-out periods for other asthma biologics: ≥4 month or duration of 5 half-lives from last dose of previous biologic. We choose what is longer the 5 half-life or 4 months.
- 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
To evaluate the change in patient asthma control after initiation of benralizumab in a real-world Russian setting
Time frame: Up to 6 month
Mean scores change from baseline in Asthma Control Questionnaire-5 (ACQ-5) after 8 weeks of treatment with benralizumab.
To evaluate the change in respiratory health-related quality of life in a real-world Russian setting
Time frame: Up to 6 month
Total scores change from baseline in St. George's Respiratory Questionnaire (SGRQ) after 8 weeks of treatment with 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 21 Oct 2024.
- CSR SynopsisLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 1 site in Russia.
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 7 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 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. 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?
To evaluate the change in patient asthma control after initiation of benralizumab in a real-world Russian setting (time frame: Up to 6 month). The study lists 2 primary outcomes in all. 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 21 Oct 2024.