Status:
UNKNOWN
Mepolizumab Effectiveness in Patients With Chronic Rhinosinusitis, Nasal Polyps and Comorbid Severe Eosinophilic Asthma
Lead Sponsor:
National and Kapodistrian University of Athens
Conditions:
Chronic Rhinosinusitis With Nasal Polyps
Severe Eosinophilic Asthma
Eligibility:
All Genders
18+ years
Brief Summary
The goal of this observational study is to learn about clinical and functional outcomes in patients with Chronic rhinosinusitis with nasal polyps and comorbid Severe Eosinophilic Asthma and patients w...
Detailed Description
Chronic rhinosinusitis (CRS) has been divided into two subtypes: CRS with (CRSwNP) and without nasal polyps (CRSsNP), which not only differ in terms of presence of polyps, but also appear to have dist...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 20 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06069310
Start Date
September 1 2023
End Date
December 20 2025
Last Update
October 5 2023
Active Locations (2)
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1
Pulmonary Dept First ICU, Evagelismos Hospital
Athens, Attica, Greece, 10676
2
Pulmonary Dept First ICU Evangelismos Hospital
Athens, Greece, 10676