2024-517538-16-00RecruitingPhase 4
TezeBarrier Study
Effect of Tezepelumab on barrier function in severe asthmatic patients with and without comorbid chronic rhinosinusitis with nasal polyps – an exploratory study
Source: EU CTIS (euclinicaltrials.eu) · Last updated 3 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 30 Oct 2024
- Start date
- 25 Sept 2025
- Lead sponsor
- Medical University Of Vienna
- Diseases
- Asthma
- EU CT number
- 2024-517538-16-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 20
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with severe asthma that is hard to control, with or without nasal polyps, who could be treated with Tezepelumab.
- Age
- 18-99 years
- Sex
- All
- Disease stage
- Severe asthma at GINA/DAL treatment step 4 or 5, not controlled despite high-dose ICS/LABA. One group also has nasal polyps (CRSwNP) confirmed by endoscopy or CT, with a mucus score of ≥ 1.
- Earlier treatment
- People who had monoclonal antibodies for asthma or polyps can join only after a washout of 3 half-lives or 3 months, whichever is longer. People on biologics now, or within 12 weeks before the start, or who ever had tezepelumab, cannot join.
- Biomarker or test result
- FeNO ≥ 20 ppB, and blood eosinophils ≥250 cells/µl, or ≥150 cells during OCS reduction or high-dose ICS, or sputum or BAL eosinophils > 2%.
Main reasons for not taking part
- Current biologic therapy, recent biologic therapy, or earlier tezepelumab
- Immunosuppressive treatment (e.g. cyclosporine)
- Current smoker, or ex-smoker who stopped less than 6 months ago
- Pregnancy
- Other lung diseases such as bronchiectasis, pulmonary fibrosis, emphysema or cystic fibrosis
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Drug and alcohol abuse
Other illness
- 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
Other
- 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
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of Vienna | Vienna | Austria | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.