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

Launched by MEDICAL UNIVERSITY OF VIENNA · Aug 12, 2021

Keywords

ClinConnect Summary

This clinical trial is focused on understanding how asthma and chronic rhinosinusitis (CRS), particularly when associated with nasal polyps, are connected. Researchers are looking at three groups of patients: those with asthma and CRS with nasal polyps, those with asthma and CRS without nasal polyps, and those with CRS and nasal polyps but without asthma. By examining samples from the nose, throat, and lungs, the study aims to discover more about the inflammation patterns in these conditions. The goal is to better tailor treatments for patients, ultimately improving their quality of life.

To be eligible for the trial, participants must be between 18 and 99 years old and have a diagnosed case of asthma that requires moderate to severe treatment. They should not be using certain types of medications, like oral corticosteroids or monoclonal antibody therapy. The researchers will carefully assess the participants' conditions through various tests to ensure they fit into one of the study groups. For those who join, they can expect to undergo evaluations that could help uncover new insights into their respiratory health, contributing to advances in treatment options for asthma and CRS.

Gender

ALL

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