Identifying biomarkers for response to mepolizumab in patients with nasal polyps and asthma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study investigates the effectiveness of mepolizumab, a biologic treatment, in patients suffering from chronic rhinosinusitis with nasal polyps, with or without bronchial asthma. The study aims to evaluate airway remodeling and identify biomarkers that differentiate responders from non-responders to the treatment over a period of 156 weeks. Patients will undergo endobronchial and nasal biopsies as part of routine care to assess tissue changes and inflammatory characteristics. The findings could enhance treatment strategies for chronic rhinosinusitis and asthma by providing insights into the underlying mechanisms of response to therapy.

Why it matters

Who can join: the full rules

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.

Where it's running

• Pulmonary Clinic of Aristotle University of Thessaloniki, George Papanikolaou Hospital
  Thessaloniki, Exochi, Greece Recruiting
• University Pulmonary Clinic, George Papanikolaou Hospital
  Thessaloniki, Greece Recruiting

Study contacts

• Principal investigator: Konstantinos Porpodis, Assoc Prof — Pulmonary Clinic, Aristotle University of Thessaloniki, George Papanikolaou Hospital
• Study coordinator: Konstantinos Porpodis, Assoc Prof
• Email: kporpodis@yahoo.gr
• Phone: 00306944728818

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.