RecruitingPhase 4NCT06288516

BenRalizumab Effect on Airway Remodeling in Severe asTHma

BenRalizumab Effect on Airway Remodeling in Severe Eosinophilic asTHmatics

Sponsor

Aristotle University Of Thessaloniki

Enrollment

45 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

Asthma; Eosinophilic Airway Remodeling

Summary

Response to biologic therapies in severe asthma is variable, with patients being either non-responders, responders or super-responders. There is currently no explanation for this broad variation in response. It is important to examine whether these patients have distinct characteristics that could help the treating physician in making the correct diagnosis in clinical practice. Aim of this clinical study is to evaluate the efficacy of benralizumab, a humanized an anti-interleukin 5 receptor α monoclonal antibody in patients with severe eosinophilic asthma and to evaluate airway remodeling before and after benralizumab treatment. Hypothesis Identification of pathological and clinical characteristics in patients with severe eosinophilic asthma after benralizumab treatment regarding the airway remodeling, inflammatory cells, and other biomarkers on a long-term basis. Research questions Is there any improvement in airway remodeling? Are there any biomarkers to predict response to benralizumab treatment in severe eosinophilic asthmatic patients?

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether benralizumab — a biologic drug that targets a type of immune cell called eosinophils — reduces airway remodeling (permanent structural changes to the airways) in people with severe asthma. **You may be eligible if...** - You have a confirmed diagnosis of severe asthma as defined by international respiratory guidelines - Your blood eosinophil level (a type of immune cell) is elevated: at least 150 cells/µL at screening or at least 300 cells/µL in the past year - You are able to provide written consent and follow study procedures **You may NOT be eligible if...** - Your asthma does not meet criteria for "severe" classification - Your eosinophil levels are not elevated enough - You have another serious lung disease, uncontrolled medical conditions, or are on treatments that conflict with the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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