Actively Recruiting
Moving Towards Precision Medicine in United Airways Disease: Unraveling Inflammatory Patterns in Asthmatic Patients With or Without Nasal Polyps
Led by Medical University of Vienna · Updated on 2025-05-07
30
Participants Needed
1
Research Sites
273 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Moving Towards Precision Medicine in United Airways Disease: Unraveling Inflammatory Patterns in Asthmatic Patients With or Without Nasal Polyps
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 99 years
- Clinical diagnosis of asthma (ICD-10 Code: J45)
- Undergoing moderate to severe asthma treatment according to GINA/DAL step 4 or 5 without oral corticosteroids or monoclonal antibody therapy
- Asthma treatment for at least 12 weeks before screening
- For groups 1 and 2 (T2-high asthma with or without polyps): FeNO greater than 25 ppB and elevated blood or sputum eosinophils as defined
- For groups with polyps: Presence of chronic rhinosinusitis with nasal polyps confirmed by endoscopy or CT
- For group 3 (CRSwNP without asthma): Presence of CRSwNP confirmed by endoscopy or CT, evidence of Type 2 inflammation (eosinophils >= 250 cells/µl or total IgE >100 kU/L), absence of asthma and N-ERD
- Patients with prior monoclonal antibody treatment included only after at least 5 half-lives or 3 months washout
You will not qualify if you...
- Pregnancy as determined by β-HCG test
- Severe anatomic nasal variations preventing access to all nasal cavity areas
- Chronic oral corticosteroid therapy
- Other lung disorders including bronchiectasis, COPD, pulmonary fibrosis, emphysema, primary ciliary dyskinesia, cystic fibrosis, parasitic infections, lung cancer
- Pulmonary conditions mimicking asthma with blood eosinophilia such as EGPA, allergic bronchopulmonary aspergillus, hypereosinophilic syndrome
- Mental condition impairing understanding of the study
- Clinically significant comorbidities as judged by the evaluating committee
- History of asthma or CRS exacerbation within 4 weeks before any visit
- Systemic corticosteroid burst within 4 weeks before any visit
- Immunosuppressive treatment like cyclosporine
- Drug and alcohol abuse
- Current smokers or former smokers who quit less than 6 months ago or with more than 10 pack-years smoking history
AI-Screening
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Trial Site Locations
Total: 1 location
1
Allgemeines Krankenhaus (AKH) Wien
Vienna, Austria, 1090
Actively Recruiting
Research Team
J
Julia Eckl-Dorna, PhD
CONTACT
S
Sven Schneider, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
SCREENING
Number of Arms
3
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