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

Recruiting · NCT05009758 · Interventional (participants receive a specific treatment) · Lead sponsor: Medical University of Vienna

View the official record on ClinicalTrials.gov →

Asthma

Interventions studied

Blood samplingBronchoscopyFeNOLung X-RayMedical history of patients, demographic data, concomitant medication, questionnaireNasal biopsyNasal mucosa mRNA samplingNasal samplingNasosorptionOral samplingPregnancy testSpirometryUPSIT smell test

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.

Who can take part

Age range

18 Years to 99 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

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

Where it is running

1 location listed.

Allgemeines Krankenhaus (AKH) Wien - Vienna, Austria

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →