NCT05708300Recruiting
Biomarkers of Response to Mepolizumab Treatment in Patients With Nasal Polyps With or Without Bronchial Asthma
Novel Insight in pathologiCal and clinicAl Attributes in Response to mepoLizumab Treatment in Patients With Chronic rhInosinusitis With Nasal pOlyPs With or Without bronchIal Asthma on a Long-term Basis (CALIOPI STUDY)
Source: ClinicalTrials.gov · Last updated 8 Mar 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 57 (estimated)
- First submitted
- 29 Dec 2022
- Start date
- 23 Feb 2024
- Primary completion date
- 1 Mar 2026
- Lead sponsor
- Aristotle University Of Thessaloniki
- Diseases
- Asthma
- NCT number
- NCT05708300
What you commit to
- Study type: Observational
- Planned participants: 57
- From 23 Feb 2024 to the primary completion date, 1 Mar 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Biologic therapy (eg: Omalizumab, Mepolizumab, Reslizumab, Dupilumab) or previous treatment with Mepolizumab
- Allergen immunotherapy in the past 6 months
- 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.
- Nasal polyps' or Asthma exacerbation, within 12 weeks prior to screening that required oral corticosteroids over 3 days or hospitalization or emergency room visit.
Other illness
- Systemic corticosteroid treatment for other chronic conditions (i.e.: autoimmune disorders, tumors, etc)
- 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).
Other
- Pregnant or nursing women, or women of child-bearing potential.
- Evidence of active systemic immunodepression (i.e..: primary or secondary immunodeficiency)
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Pulmonary Clinic, George Papanikolaou Hospital Coordinator of this site? Confirm its status | Thessaloniki | Greece | Recruiting |
| Pulmonary Clinic of Aristotle University of Thessaloniki, George Papanikolaou Hospital Coordinator of this site? Confirm its status | Thessaloniki | Greece | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.