MRI and Lung Function Measures of Benralizumab Response in Asthma

Using Benralizumab to Explore Treatment Response Patterns in Functional Lung MRI and Advanced Measures of Lung Function

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04182802

Acronym

MR BEN

Enrollment

Registered

2019-12-02

Start date

2020-02-13

Completion date

2022-07-01

Last updated

2021-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Brief 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. 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Inclusion criteria

* 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.

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
Change in percentage ventilated lung volume	Baseline to 16 weeks	Measurement of lung volume assessed by magnetic resonance imaging

Outcome results