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BenRalizumab Effect on Airway Remodeling in Severe asTHma

NCT06288516 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2024-03-04

No results posted yet for this study

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?

Conditions

  • Asthma; Eosinophilic
  • Airway Remodeling

Interventions

DRUG

Benralizumab 30 mg/ml

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

Sponsors & Collaborators

  • Pulmonary Clinic, University of Ioannina

    collaborator UNKNOWN

  • Pulmonary Clinic, Democritus University of Thrace

    collaborator UNKNOWN

  • 2nd Pulmonary Clinic, Kapodistrian University of Athens

    collaborator UNKNOWN

  • University Hospital of Crete

    collaborator OTHER

  • Pulmonary and Respiratory Failure Department, National and Kapodistrian University of Athens

    collaborator UNKNOWN

  • University Hospital of Patras

    collaborator OTHER

  • Aristotle University Of Thessaloniki

    lead OTHER

Principal Investigators

  • Kalliopi Domvri, Dr · Aristotle University Of Thessaloniki

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2025-12-31
Completion
2026-06-01

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06288516 on ClinicalTrials.gov