MRI and Lung Function Measures of Benralizumab Response in Asthma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-13

Study Completion Date

2022-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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eosinophilic asthma

No interventions assigned to this group

Eligibility Criteria

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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).
* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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STH20679

Identifier Type: -

Identifier Source: org_study_id