NCT05708300 Biomarkers of Response to Mepolizumab Treatment in Patients With Nasal Polyps With or Without Bronchial Asthma
| NCT ID | NCT05708300 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Aristotle University Of Thessaloniki |
| Condition | Chronic Rhinosinusitis With Nasal Polyps |
| Study Type | OBSERVATIONAL |
| Enrollment | 57 participants |
| Start Date | 2024-02-23 |
| Primary Completion | 2026-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 57 participants in total. It began in 2024-02-23 with a primary completion date of 2026-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Adult patients \> 18 years with bilateral Nasal Polyps * Symptoms VAS scores (for nasal obstruction, hyposmia, post-nasal drip, sneezing, rhinorrhea; 0-10 for each symptom) \> 24 in spite of treatment with standard of care treatment. * Patients with bilateral sinonasal polyps with a need for surgery as described by: Lund-Mackay score \> 4, Lund Kennedy score \> 6, a minimum total Nasal polyp score of 5 out of a maximum score of 8 at screening, ongoing symptoms for at least 12 weeks prior to screening, * Concerning patients with asthmatics with nasal polyps: subjects must have a medical history of asthma as confirmed by asthma related symptoms and by bronchodilator response (BDR) (GINA 2022) or positive methacholine challenge according to ERS guidelines. Exclusion Criteria: * Pregnant or nursing women, or women of child-bearing potential. * Biologic therapy (eg: Omalizumab, Mepolizumab, Reslizumab, Dupilumab) or previous treatment with Mepolizumab * Allergen immunotherapy in the past 6 months * Systemic corticosteroid treatment for other chronic conditions (i.e.: autoimmune disorders, tumors, etc) * Prior/concomitant therapy: use of immunosuppressive medication (including but not limited to: methotrexate, troleandomycin, cyclosporine, azathioprine, or any experimental anti-inflammatory therapy) within 3 months prior to Visit 1 and during the study period. * Evidence of active systemic immunodepression (i.e..: primary or secondary immunodeficiency) * History of malignancy of any organ system or any other serious co-morbidities defined by the treating physician. * Primary diagnosis of lung disease other than asthma (chronic obstructive lung disease (COPD), asthma-COPD overlap (ACO), interstitial lung disease, sarcoidosis, bronchiectasis, cystic fibrosis, primary ciliary dyskinesia, active tuberculosis, allergic bronchopulmonary aspergillosis (ABPA), current lung cancer or other blood, lymphatic or solid organ malignancy, autoimmune diseases of the skin, muscle-skeletal or gastrointestinal system needing systemic corticosteroids, immunosuppressants or biologic treatment as well as individuals with granulomatosis with polyangiitis (Wegener's granulomatosis) and eosinophilic granulomatosis polyangiitis (Churg-Strauss syndrome). * Nasal polyps' or Asthma exacerbation, within 12 weeks prior to screening that required oral corticosteroids over 3 days or hospitalization or emergency room visit.
Contact & Investigator
Konstantinos Porpodis, Assoc Prof
PRINCIPAL INVESTIGATOR
Pulmonary Clinic, Aristotle University of Thessaloniki, George Papanikolaou Hospital
Frequently Asked Questions
Who can join the NCT05708300 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Rhinosinusitis With Nasal Polyps. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05708300 currently recruiting?
Yes, NCT05708300 is actively recruiting participants. Contact the research team at kporpodis@yahoo.gr for enrollment information.
Where is the NCT05708300 trial being conducted?
This trial is being conducted at Thessaloniki, Greece, Thessaloniki, Greece.
Who is sponsoring the NCT05708300 clinical trial?
NCT05708300 is sponsored by Aristotle University Of Thessaloniki. The principal investigator is Konstantinos Porpodis, Assoc Prof at Pulmonary Clinic, Aristotle University of Thessaloniki, George Papanikolaou Hospital. The trial plans to enroll 57 participants.