Using MRI to assess early treatment response in severe eosinophilic asthma

FUNLUM: Functional Lung MRI for Early Treatment Response Assessment and Outcome Prediction for Patients With Severe Eosinophilic Asthma on Anti IL 5 Antibody Therapy

This study is testing if using MRI can help doctors see early signs of how well a new asthma treatment is working for people with severe eosinophilic asthma.

Quick facts

• Study type: Observational
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hannover Medical School (Academic / other)
• Drugs / interventions: Mepolizumab, reslizumab, benralizumab
• Locations: 1 site (Hanover, Niedersachsen)
• Trial ID: NCT04512521 on ClinicalTrials.gov

What this trial studies

This observational study focuses on patients with severe eosinophilic asthma who are candidates for biologic therapy. It aims to utilize functional lung MRI to detect early changes in lung microstructure that may indicate treatment response, potentially allowing for quicker adjustments to therapy. The study will enroll patients who are uncontrolled despite maximized inhalation therapy or are only controlled with oral corticosteroids. By identifying non-responders earlier, the study seeks to reduce overtreatment and undertreatment in this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with severe eosinophilic asthma who meet specific treatment criteria for anti-IL-5 antibody therapy.

Not a fit: Patients with asthma not classified as severe eosinophilic or those who do not meet the eligibility criteria will likely not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more personalized and effective treatment plans for patients with severe eosinophilic asthma.

How similar studies have performed: While the use of MRI in asthma assessment is innovative, similar studies have not yet established the efficacy of this approach, making it a novel exploration.

Eligibility criteria

Inclusion Criteria:

* Able and willing to give written informed consent.
* Male and female subjects, aged ≥ 18 years.
* Patients which are eligible for treatment using anti-IL-5 -antibody treatment following guidelines: severe eosinophilic asthma and blood eosinophils of ≥150 cells/μL at screening or ≥ 300 cells/μL within 12 months prior to treatment
* Physician-diagnosed severe asthma according to ERS/ATS guidelines
* Treatment with a total daily dose of medium or high-dose ICS (e.g. ≥ 500μg fluticasone propionate, ≥ 800μg budesonide or equivalent total daily dose). ICS can be contained within an ICS/LABA combination product.
* At least one additional maintenance asthma controller e.g. LABA, LTRA, theophylline, LAMA, etc. with or without OCS

Exclusion Criteria:

* Any clinically relevant abnormal findings in physical examination, clinical chemistry, hematology, urinalysis, vital signs, lung function at screening visit, which, in the opinion of the investigator, may either put the subject at risk because of participation in the study or may influence the results of the study, or the subject's ability to participate in the study.
* Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, endocrine disease or pulmonary disease other than Asthma (including but not confined to tuberculosis, bronchiectasis, cystic fibrosis, pulmonary hypertension, sarcoidosis, interstitial lung disease or lung fibrosis).
* History of drug or alcohol abuse.
* Risk of non-compliance with study procedures.
* Suspected inability to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study.
* History of an acute respiratory infection four weeks prior to enrolment. These patients will not be eligible, but will be permitted to be rescreened 4 weeks after the resolution of the respiratory tract infection.
* Subjects with severe renal impairment (GFR ≤ 30 mL/min) including those with end-stage renal disease requiring dialysis or urinary retention.
* Subjects with active/ clinical history of COPD.
* Subjects unable to undergo MRI scans, including claustrophobia or presence of any metal objects within the patient, preventing from MRI scan (e.g. pacemaker, aneurysm clips).
* History of asthma exacerbation that required treatment with antibiotics, systemic steroids (oral or intravenous) or hospitalization within 3 months prior to enrolment.
* Subjects with a body mass index (BMI) of more than 35 kg/m2.

Where this trial is running

Hanover, Niedersachsen

• Hannover Medical School — Hanover, Niedersachsen, Germany (Recruiting)

Study contacts

• Principal investigator: Jens Vogel-Claussen, MD — Hannover Medical School
• Study coordinator: Hendrik Suhling, MD

Conditions Asthma; Eosinophilic