TezeBarrier Study
Key facts
- Where
- Vienna, AusztriaSee the site
- Phase
- 4. fázis
Where in Ausztria
- Medical University of ViennaVienna, AusztriaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Medical University Of Vienna
- Trial code
- EU 2024-517538-16-00
- Record updated
- 2025. március 3.
- Original description
To determine the effect of Tezepelumab treatment on the barrier function of upper and lower airways in patients suffering from severe asthma with CRSwNP and without CRS and elevated T2 biomarkers. This will be achieved by analysis of epithelial barrier function upon challenge with various harmful substances (e.g. cigarette smoke extract, allergens, and PolyIC) in cultured primary respiratory tract epithelial cells using the xCELLigence system for continuous monitoring of barrier function.Read full original descriptionShow less
Effect of Tezepelumab on barrier function in severe asthmatic patients with and without comorbid chronic rhinosinusitis with nasal polyps – an exploratory study
To determine the effect of Tezepelumab treatment on the barrier function of upper and lower airways in patients suffering from severe asthma with CRSwNP and without CRS and elevated T2 biomarkers. This will be achieved by analysis of epithelial barrier function upon challenge with various harmful substances (e.g. cigarette smoke extract, allergens, and PolyIC) in cultured primary respiratory tract epithelial cells using the xCELLigence system for continuous monitoring of barrier function.
Inclusion: Provision of informed consent prior to any study specific procedures; Age 18-99 years and willing to participate in the study; Have a recorded clinical diagnosis of asthma (ICD-10 Code: J45); Undergo severe asthma treatment according to GINA/DAL treatment step 4 or 5; Meet the requirements for treatment of severe asthma with Tezepelumab defined as: - severe asthma that remains uncontrolled despite a high dosage of ICS/LABA, or that requires a high dose to prevent it from becoming uncontrolled. One of the following criteria needs to be fulfilled: • ACT <20, ACQ>0.75 • During the last 12 months 2 courses of OCS for at least 3 days due to severe asthma symptoms • During last 12 months one exacerbation requiring hospitalization • Lung function: FEV1 <80% predicted - FeNO ≥ 20 ppB - had either ≥250 eosinophils /µl measured in the blood OR measurement of blood eosinophils ≥150 cells during reduction of OCS dosing or high dose ICS and/or one measurement of sputum eosinophils > 2% or BAL eosinophils > 2% - Group with polyps: Presence of nasal polyps as confirmed by endoscopy or CT according to the European Position Paper on Rhinosinusitis and Nasal Polyps Guidelines; mucus score of ≥ 1; Patients with a history of treatment with monoclonal antibodies for asthma or polyps will only be included if at least a washout period of 3 half-lives or 3 months have passed (whichever is longer).
Exclusion: Drug and alcohol abuse; Patients with current therapy with biologics as well as therapy with biologics 12 weeks (3 half-lives) before the start of the study or history of therapy with tezepelumab; Patients with any other confounding underlying lung disorder including but not limited to: o Bronchiectasis, pulmonary fibrosis, emphysema, primary ciliary dyskinesia o 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; Immunosuppressive treatment (e.g. cyclosporine); Current smoker and former smokers if stopped smoking <6 months; Pregnancy (as determined by urine pregnancy test); Patients with severe anatomic variations or deviations that do not allow access to all areas in the nasal cavity or to perform bronchoscopy; Patients with other causes of nasal polyps than Type 2 CRS inflammation; Contraindications for endobronchial and/or transbronchial biopsy; Patients with clinically meaningful comorbidity as determined by the evaluating committee.