Effect of Mepolizumab on Chronic Rhinosinusitis and Severe Eosinophilic Asthma
Evaluation of Mepolizumab Effectiveness in Patients With Chronic Rhinosinusitis With Nasal Polyps and Comorbid Severe Eosinophilic Asthma: an Integrative Multi-omics Approach to Assess Biomarker Signatures of Responsive Disease Endotypes
This study is trying to see if the medication mepolizumab can help people with chronic sinus issues and severe asthma feel better and improve their symptoms.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National and Kapodistrian University of Athens Academic / other |
| Drugs / interventions | mepolizumab |
| Locations | 2 sites (Athens, Attiki and 1 other locations) |
| Trial ID | NCT06069310 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the clinical and functional outcomes of mepolizumab treatment in patients with Chronic Rhinosinusitis with nasal polyps and comorbid Severe Eosinophilic Asthma, as well as in patients with Chronic Rhinosinusitis with nasal polyps only. Participants will provide nasal, blood, and sputum samples before and at multiple time points after starting mepolizumab therapy. The study will compare these patients to healthy controls to assess changes in airway microbiota and gene expression. The research seeks to understand the impact of mepolizumab on disease severity and treatment response.
Who should consider this trial
Good fit: Ideal candidates include adults diagnosed with Chronic Rhinosinusitis with nasal polyps, with or without comorbid Severe Eosinophilic Asthma, who are eligible for biologic treatment.
Not a fit: Patients under 18 years of age, those with COPD, or individuals with known immunodeficiency or autoimmune diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients suffering from Chronic Rhinosinusitis and Severe Eosinophilic Asthma.
How similar studies have performed: Other studies have shown promising results with mepolizumab in similar patient populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Eligible for inclusion will be patients diagnosed with CRSwNP according to the European Position Paper on Rhinosinusitis and Nasal Polyps that fulfill the criteria for initiating treatment with biologics as standard of care \[49\], suffering or not from comorbid severe asthma (CRSwNP + AS, CRSwNP - AS, respectively) who will consent to participate in the study. The study will not influence prescribing of mepolizumab to patients. Eligible to treatment women in childbearing potential will be informed before consent that they must take care of contraception and potential pregnancy during therapy as there is not enough data regarding the use of mepolizumab during pregnancy. All patients with severe asthma will be qualified for treatment with mepolizumab in accordance with GINA guidelines. Exclusion Criteria: * Patients less than 18 years of age, subjects suffering from COPD, known or suspected immunodeficiency or autoimmune disease, chronic interstitial lung diseases, cystic fibrosis, individuals exposed to systemic corticosteroid/immunosuppressive treatments, biologics for asthma care or antibiotics within the previous 3 months before mepolizumab administration, active smokers and obese individuals will be excluded from this study. Pregnant women will not be included into the study because of the potential changes that their microbiome and other host parameters could undergo during pregnancy. The control group will comprise healthy volunteers who will be free from CRS, asthma, and atopy.
Where this trial is running
Athens, Attiki and 1 other locations
- Pulmonary Dept First ICU, Evagelismos Hospital — Athens, Attiki, Greece (Recruiting)
- Pulmonary Dept First ICU Evangelismos Hospital — Athens, Greece (Recruiting)
Study contacts
- Principal investigator: Paraskevi Katsaounou, MD, PhD, Msc — National Kapodistrian University of Athens
- Study coordinator: Paraskevi Katsaounou, MD, PhD, Msc
- Email: paraskevikatsaounou@gmail.com
- Phone: +302132043384
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.