NCT05009758 Moving Towards Precision Medicine in United Airways Disease: Unraveling Inflammatory Patterns in Asthmatic Patients With or Without Nasal Polyps

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This trial targets 30 participants in total. It began in 2021-09-01 with a primary completion date of 2025-09.

Brief Summary

Asthma and chronic rhinosinusitis (CRS) are inflammatory diseases of the respiratory tract, asthma from the lower part, and CRS, from the upper part. In theory, these parts are correlated as if they are one single organ, namely "united airways", which means that if one is affected by any condition, the other might be impacted as well. However, this relationship has not yet been described down to the cellular and molecular levels. By investigating patients that have (1) asthma and CRS with nasal polyp, (2) asthma and CRS without nasal polyp, and (3) just CRS with nasal polyp, we aim to determine the correlation of the upper and lower part of the respiratory tract. At first, the characterization of disease will be determined by established clinical criteria, such as lung function, blood analysis for the presence of eosinophils (a type of white cells), and nasal polyp score. To continue, in-depth analysis of nose, oropharynx, and lung samples will help gain information about the inflammatory profile and local microbiome of the three different groups of patients through molecular and cellular assays. The results of this study will help to describe the hypothesis of the united airways which will provide better guidance for medical treatment of asthma and CRS with or without polyp, thus improving the life quality of patients.

Eligibility Criteria

Inclusion Criteria: All patients who * 18-99 years of age * have a recorded clinical diagnosis of asthma (ICD-10 Code: J45) * undergo moderate-serve asthma treatment according to GINA/DAL treatment step 4 or step 5 without oral corticosteroid or monoclonal antibody therapy * Asthma treatment for a minimum of 12 weeks prior to screening visit * Group 1 and 2 - T2-high asthma with or without polyps: * FeNO \> 25 ppB * had either two times \>= 250 eosinophils /µl measured in the blood OR one measurement of blood eosinophils \>= 250 cells/µl (one of the two measurements at the screening visit) and/or one measurement of sputum eosinophils \> 2% within the last 12 months * Group with polyps: Presence of CRSwNP as confirmed by endoscopy or CT according to the European Position Paper on Rhinosinusitis and CRSwNP Guidelines) * Group 3 - CRSwNP in absence of asthma: * Presence of CRSwNP as confirmed by endoscopy or CT according to the European Position Paper on Rhinosinusitis and Nasal Polyps Guidelines * Evidence of Type 2 inflammation: eosinophils \>= 250 cells/µl measured in the blood OR total IgE \>100 kU/L at the screening visit * Absence of asthma and N-ERD * Patients with a history of treatment with monoclonal antibodies for asthma or polyps will only be included if at least a wash out period of 5 half-lives or at least 3 months have passed Exclusion Criteria: * Pregnancy (as determined by ß-HCG test) * Patients with severe anatomic variations or deviations that do not allow access to all areas in the nasal cavity * Patients undergoing chronic oral corticosteroid therapy * Patients with any other confounding underlying lung disorder including but not limited to: * Bronchiectasis, chronic obstructive pulmonary disorder (COPD), pulmonary fibrosis, emphysema, primary ciliary dyskinesia * Cystic fibrosis, any known parasitic infections, and lung cancer * Patients with pulmonary conditions with symptoms of asthma and blood eosinophilia including but not limited to: Eosinophilic granulomatosis with polyangiitis (EGPA), allergic bronchopulmonary aspergillus, and hypereosinophilic syndrome * A mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study * Patients with clinically meaningful comorbidity as determined by the evaluating committee * Patients with a history of exacerbation of chronic rhinosinusitis or asthma 4 weeks prior to any visit * Intake of a burst of systemic corticosteroids 4 weeks prior to any visit. * Immunosuppressive treatment (e.g. cyclosporine) * Drug and alcohol abuses * Current smoker * Former smoker if stopped smoking \<6 months and/or has \>10 pack-years

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