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)

What this Trial Is About

Researchers are studying mepolizumab, a biologic drug already approved for severe asthma, to better understand its effects on patients with chronic rhinosinusitis with nasal polyps (CRSwNP), both with and without bronchial asthma. The study aims to identify biomarkers and characteristics that predict how patients respond to mepolizumab, focusing on tissue remodeling in the nose and bronchus over a long period of 156 weeks. This research also explores the microbiome in the nose, pharynx, and bronchus to see how it relates to treatment response. Patients in this study will receive 39 doses of mepolizumab (100 mg) through subcutaneous injections every 30 days. The study includes two groups: those with nasal polyps and asthma, and those with nasal polyps without asthma. Tissue samples from endobronchial and nasal biopsies, as well as bronchial washings, will be collected at baseline, after 52 weeks, and after 156 weeks. The study will also assess airway remodeling and inflammatory biomarkers using various laboratory methods. Participants will have regular clinic visits for assessments including vital signs, lung function tests (spirometry and impulse oscillometry), nasal airflow measurements, and questionnaires on asthma control, quality of life, and sleep quality. Blood and sputum samples will be collected periodically. Researchers will monitor adverse events and patient compliance throughout the 156-week treatment period. The main outcomes measured include changes in airway tissue structure, microbiome composition, and inflammatory markers to better understand response to mepolizumab therapy.

Biomarkers of Response to Mepolizumab Treatment in Patients With Nasal Polyps With or Without Bronchial Asthma