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RECRUITING
NCT06288516
PHASE4

BenRalizumab Effect on Airway Remodeling in Severe asTHma

Sponsor: Aristotle University Of Thessaloniki

View on ClinicalTrials.gov

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?

Official title: BenRalizumab Effect on Airway Remodeling in Severe Eosinophilic asTHmatics

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2024-03-01

Completion Date

2026-06-01

Last Updated

2024-03-04

Healthy Volunteers

No

Interventions

DRUG

Benralizumab 30 mg/ml

Benralizumab administered subcutaneously every 4 weeks for the first 3 dose and then every 8 weeks

Locations (1)

Pulmonary Clinic, Aristotle University of Thessaloniki, George Papanikolaou Hospital

Thessaloniki, Greece