Actively Recruiting
BenRalizumab Effect on Airway Remodeling in Severe asTHma
Led by Aristotle University Of Thessaloniki · Updated on 2024-03-04
45
Participants Needed
1
Research Sites
117 weeks
Total Duration
On this page
Sponsors
A
Aristotle University Of Thessaloniki
Lead Sponsor
P
Pulmonary Clinic, University of Ioannina
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
BenRalizumab Effect on Airway Remodeling in Severe asTHma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide written informed consent before participation and comply with study requirements
- Confirmed severe asthma diagnosis and treatment according to ATS/ERS guidelines and GINA 2023
- Blood eosinophils 6150 cells/µl at screening or 6300 cells/µl in the last 12 months
- History of at least 1 asthma exacerbation in the previous year under high-dose inhaled corticosteroid plus LABA with or without LAMA, or systemic corticosteroids for at least 3 days
- Meet requirements for biologic therapy with benralizumab
You will not qualify if you...
- Asthma exacerbation requiring hospitalization or emergency room visit within 6 weeks before screening
- Prior use of other biologics that may affect disease progression
- Pregnant or nursing women, or women of child-bearing potential
- History of any malignancy or serious co-morbidities as defined by the treating physician
- History of conditions other than asthma that cause elevated eosinophils, such as hypereosinophilic syndromes, Churg-Strauss Syndrome, or eosinophilic esophagitis
AI-Screening
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Trial Site Locations
Total: 1 location
1
Pulmonary Clinic, Aristotle University of Thessaloniki, George Papanikolaou Hospital
Thessaloniki, Greece, 57010
Actively Recruiting
Research Team
K
Kalliopi Domvri, Dr
CONTACT
K
Konstantinos Porpodis, Ass Prof
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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