Actively Recruiting
Biomarkers of Response to Mepolizumab Treatment in Patients With Nasal Polyps With or Without Bronchial Asthma
Led by Aristotle University Of Thessaloniki · Updated on 2024-03-08
57
Participants Needed
2
Research Sites
157 weeks
Total Duration
On this page
Sponsors
A
Aristotle University Of Thessaloniki
Lead Sponsor
D
Department of Otorhinolaryngology, Head and Neck Surgery, George Papanikolaou Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Mepolizumab is a biologic agent already approved for severe asthma. Recently, there is increasing evidence concerning the benefit of anti-IL5 treatments upon patients with nasal polyposis with or without severe asthma. The novelty of this project is that no biologic agent has yet been fully investigated to identify any biomarkers of response for patients with nasal polyps with or without asthma including sinonasal tissue remodeling a key element in the resultant histopathological changes of the inflammation. The investigation of airway remodeling of various locations (nose and bronchus) under mepolizumab treatment will be our primary objective on the long-term basis of 156 weeks of treatment. Endobronchial and nasal biopsies will be performed as routine care for tissue evauation and disease investigation for every patient. Besides, the united airways will provide better guidance for medical treatment of chronic rhinosinusitis (CRS) patients with nasal polyps (CRSwNP) and asthma. The initial idea is based on investigating the characteristics that could predict the effectiveness of mepolizumab on patients with nasal polyposis with or without asthma. Patients will receive 39 doses of mepolizumab for 156 weeks. An additional aim of this study is to identify characteristics of non-responders and responders to mepolizumab. Responders will be identified based on airway remodeling status, biomarkers in tissue and secretion samples and on the reduction of the need of surgery through Lund-Kennedy endoscopic score, Lund-Mackay score and patient's clinical status in the 6th, 12th and 36th month after the initiation of treatment. Regarding the unified airway system, nose and pharyngeal microbiome will be evaluated before and after 52 weeks of mepolizumab treatment in patients with nasal polyps whereas in patients with nasal polyps and asthma bronchus microbiome will also be evaluated. Lung samples will help gain information about the inflammatory profile and local microbiome of CRSwNP patients with asthma through molecular and cellular assays. The human Pharyngeal Microbiome might play a protective role in Respiratory Tract Infections and it has been reported that the microbiome provides critical signals to promote maturation of immune cells and differentiation of the tissue. Thus, we will make an effort to correlate microbiome of various locations with clinical and laboratory characteristics of responders and non-responders to mepolizumab treatment.
CONDITIONS
Official Title
Biomarkers of Response to Mepolizumab Treatment in Patients With Nasal Polyps With or Without Bronchial Asthma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients over 18 years with bilateral nasal polyps
- Symptoms with a combined severity score (VAS) over 24 despite standard treatment
- Bilateral sinonasal polyps needing surgery, indicated by Lund-Mackay score over 4, Lund Kennedy score over 6, and nasal polyp score at least 5 out of 8
- Patients with nasal polyps and asthma must have confirmed asthma by symptoms and bronchodilator response or methacholine challenge
You will not qualify if you...
- Pregnant or nursing women, or women who can become pregnant
- Previous treatment with biologic therapies including omalizumab, mepolizumab, reslizumab, or dupilumab
- Allergen immunotherapy within the past 6 months
- Use of systemic corticosteroids for other chronic conditions
- Use of immunosuppressive medications within 3 months before screening and during the study
- Active systemic immunodeficiency
- History of malignancy or other serious health conditions as determined by the doctor
- Lung diseases other than asthma, including COPD, interstitial lung disease, sarcoidosis, bronchiectasis, cystic fibrosis, or current lung cancer
- Recent nasal polyps or asthma exacerbation requiring oral corticosteroids for more than 3 days, hospitalization, or emergency room visit within 12 weeks before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Pulmonary Clinic of Aristotle University of Thessaloniki, George Papanikolaou Hospital
Thessaloniki, Exochi, Greece, 57010
Actively Recruiting
2
University Pulmonary Clinic, George Papanikolaou Hospital
Thessaloniki, Greece, 57010
Actively Recruiting
Research Team
K
Konstantinos Porpodis, Assoc Prof
CONTACT
K
Kalliopi Domvri, Dr
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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