AsthmaMR BENNCT04182802
MRI and Lung Function Measures of Benralizumab Response in Asthma
An observational study of Asthma, run by Sheffield Teaching Hospitals NHS Foundation Trust.
Trial summary
New treatments have been developed for asthma that are good at preventing asthma attacks and improving day-to-day symptoms. Alongside the development of these new drugs, there are new ways of measuring how the lung is affected by asthma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 13 Feb 2020to 1 Jul 2022
- 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
- Adult, Older adult
Study population: This is a pragmatic, cohort feasibility study, the primary aim of which is to determine which parameters of functional and structural lung MRI change over what time course after the introduction of a anti-eosinophil strategy in people with eosinophilic asthma. At present, the first-line licensed choice for anti-eosinophil therapies is mepolizumab, which has been shown to be effective at reducing exacerbations of asthma. Mepolizumab is given every 4 weeks. Benralizumab has two possible advantages over mepolizumab: swifter onset, and less frequent administration (it is given 4 weekly for the first three injections, then 8 weekly). People who would be eligible for either therapy will be offered a choice of participating in this clinical study or receiving mepolizumab through standard NHS pathways. Candidate patients will be identified in severe asthma clinics at Sheffield Teaching Hospitals and through the associated clinics at Rotherham, Doncaster, Barnsley and Chesterfield.
Who may be able to join
- People with eosinophilic asthma meeting the National Institute for Health and Clinical Excellence (NICE) criteria for benralizumab therapy based on eosinophil count and exacerbation rates will be offered the chance to participate in this study.
Who cannot join
- Any medical illness that in the opinion of the investigator is likely to significantly impact on the response to benralizumab or the outcome of the MRI and lung function testing.
- Non-concordance with routine asthma therapies (this would be assessed as a mandatory part of NICE-based criteria).
- Any additional significant lung illness that would impact on likelihood of response to benralizumab. Of note, trivial stable bronchiectasis that in the opinion of the patient's clinician is not clinically significant nor likely to result in either recurrent exacerbations or impairment of interpretation of investigation results will not be exclusion criteria. Part of the initial inclusion regarding eligibility by NICE criteria include an assessment of a likely eosinophilic asthmatic phenotype with probability of treatment response, and potential subjects with complex lung disease would be unlikely to be eligible.
- Current cigarette smoking, or cigarette smoking within the past 6 months
- Significant lifetime smoking history of ≥20 pack years
- Previous use of another biologic therapy targeting eosinophils within 6 months of enrollment
- Pregnancy, planning pregnancy, or breast feeding. Women of childbearing potential must use effective contraception (concordant use of hormonal contraceptive, intrauterine device, total abstinence), and urine pregnancy tests will be performed before scans.
- Abnormal renal function (eGFR <30), to avoid risks from Gadolinium chelate MRI contrast agents.
About this study
Official title: Using Benralizumab to Explore Treatment Response Patterns in Functional Lung MRI and Advanced Measures of Lung Function
New treatments have been developed for asthma that are good at preventing asthma attacks and improving day-to-day symptoms. Alongside the development of these new drugs, there are new ways of measuring how the lung is affected by asthma. In particular, investigators have developed ways of seeing how air moves in the lungs of people with asthma, using MRI scanning. This study aims to see how quickly these new drugs result in changes in the way the lung is working, as seen in the MRI scans and other breathing tests. This will help clinicians in the future to decide who is likely to respond to these new medicines, and once patients have started taking the drugs, will help clinicians to decide whether long term treatment is likely to benefit the people receiving them.
In this study, the investigators plan to do extra breathing tests and MRI scans on people who are receiving the drug as part of their usual clinical care. The study will not change an individual's treatment, but will give the investigators more information about the patients' illnesses and the way the patients' bodies respond to treatment.
- Conditions
- Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| eosinophilic asthma | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in percentage ventilated lung volume
Measurement of lung volume assessed by magnetic resonance imaging
Measured: Baseline to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2019
- Study start13 Feb 2020 (estimated)
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Why it stopped: Funding withdrawn due to COVID related delays.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca, University of Sheffield, University of Dundee
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04182802
- Sponsor's protocol ID
- STH20679
- Acronym
- MR BEN
- Status last verified
- Nov 2019
- First submitted
- 26 Nov 2019
- Last updated
- 19 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Benralizumab to Explore Treatment Response Patterns in Functional Lung MRI and Advanced Measures of Lung Function
- ClinicalTrials.gov ID
- NCT04182802
- Acronym / sponsor ID
- MR BEN / STH20679
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Funding withdrawn due to COVID related delays.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- AstraZeneca, University of Sheffield, University of Dundee
- Study start
- 13 Feb 2020 (estimated)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 2 Dec 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.
New treatments have been developed for asthma that are good at preventing asthma attacks and improving day-to-day symptoms. Alongside the development of these new drugs, there are new ways of measuring how the lung is affected by asthma. In particular, investigators have developed ways of seeing how air moves in the lungs of people with asthma, using MRI scanning. This study aims to see how quickly these new drugs result in changes in the way the lung is working, as seen in the MRI scans and other breathing tests. This will help clinicians in the future to decide who is likely to respond to these new medicines, and once patients have started taking the drugs, will help clinicians to decide whether long term treatment is likely to benefit the people receiving them.
In this study, the investigators plan to do extra breathing tests and MRI scans on people who are receiving the drug as part of their usual clinical care. The study will not change an individual's treatment, but will give the investigators more information about the patients' illnesses and the way the patients' bodies respond to treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| eosinophilic asthma | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This is a pragmatic, cohort feasibility study, the primary aim of which is to determine which parameters of functional and structural lung MRI change over what time course after the introduction of a anti-eosinophil strategy in people with eosinophilic asthma. At present, the first-line licensed choice for anti-eosinophil therapies is mepolizumab, which has been shown to be effective at reducing exacerbations of asthma. Mepolizumab is given every 4 weeks. Benralizumab has two possible advantages over mepolizumab: swifter onset, and less frequent administration (it is given 4 weekly for the first three injections, then 8 weekly). People who would be eligible for either therapy will be offered a choice of participating in this clinical study or receiving mepolizumab through standard NHS pathways. Candidate patients will be identified in severe asthma clinics at Sheffield Teaching Hospitals and through the associated clinics at Rotherham, Doncaster, Barnsley and Chesterfield.
Key inclusion criteria (1 listed)
- People with eosinophilic asthma meeting the National Institute for Health and Clinical Excellence (NICE) criteria for benralizumab therapy based on eosinophil count and exacerbation rates will be offered the chance to participate in this study.
Key exclusion criteria (8 listed)
- Any medical illness that in the opinion of the investigator is likely to significantly impact on the response to benralizumab or the outcome of the MRI and lung function testing.
- Non-concordance with routine asthma therapies (this would be assessed as a mandatory part of NICE-based criteria).
- Any additional significant lung illness that would impact on likelihood of response to benralizumab. Of note, trivial stable bronchiectasis that in the opinion of the patient's clinician is not clinically significant nor likely to result in either recurrent exacerbations or impairment of interpretation of investigation results will not be exclusion criteria. Part of the initial inclusion regarding eligibility by NICE criteria include an assessment of a likely eosinophilic asthmatic phenotype with probability of treatment response, and potential subjects with complex lung disease would be unlikely to be eligible.
- Current cigarette smoking, or cigarette smoking within the past 6 months
- Significant lifetime smoking history of ≥20 pack years
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 percentage ventilated lung volume
Time frame: Baseline to 16 weeks
Measurement of lung volume assessed by magnetic resonance imaging
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2021.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Sheffield Teaching Hospitals NHS Foundation Trust.
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 1 inclusion and 8 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: withdrawn, as of the sponsor's last update on 19 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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 percentage ventilated lung volume (time frame: Baseline to 16 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 19 Nov 2021.