Asthma BronchialeTezebarrierNCT07046117
Effect of Tezepelumab on Barrier Function in Severe Asthmatic Patients With and Without Comorbid Chronic Rhinosinusitis With Nasal Polyps
A study testing Tezepelumab in people with Asthma Bronchiale and Chronic Rhinosinusitis With Nasal Polyps (CRSwNP), run by Medical University of Vienna at 1 site in Austria.
Trial summary
In this study, we will investigate the effect of tezepelumab on the epithelial barrier function of the upper and lower airways in patients suffering from severe asthma with and without chronic rhinosinusitis with nasal polyps. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Asthma Bronchiale, Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
- What is being tested?
- Tezepelumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustria
- Study dates
- 1 Oct 2025to 1 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 15Show fewer
- 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)
Who cannot join
- 1. 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 2. Pregnancy (as determined by urine pregnancy test) 3. Patients with severe anatomic variations or deviations that do not allow access to all areas in the nasal cavity or to perform bronchoscopy 4. Patients with any other confounding underlying lung disorder including but not limited to:
- Bronchiectasis, pulmonary fibrosis, emphysema, primary ciliary dyskinesia
- Cystic fibrosis, any known parasitic infections and lung cancer
- 5. Patients with other causes of nasal polyps than Type 2 CRS inflammation 6. 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 7. Contraindications for endobronchial and/or transbronchial biopsy. 8. A mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study 9. Patients with clinically meaningful comorbidity as determined by the evaluating committee 10. Immunosuppressive treatment (e.g. cyclosporine) 11. Drug and alcohol abuse 12. Current smoker and former smokers if stopped smoking <6 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site
Medical University of Vienna
Vienna, Austria, A-1090
Julia Eckl-Dorna, MD, PhD, +43140400 ext. 34380, julia.eckl-dorna@meduniwien.ac.at
Victoria Stanek, MSc, +43140400 ext. 34380, victoria.stanek@meduniwien.ac.at
About this study
Official title: Effect of Tezepelumab on Barrier Function in Severe Asthmatic Patients With and Without Comorbid Chronic Rhinosinusitis With Nasal Polyps - an Exploratory Study
In this study, we will investigate the effect of tezepelumab on the epithelial barrier function of the upper and lower airways in patients suffering from severe asthma with and without chronic rhinosinusitis with nasal polyps. This will be achieved by analysis of epithelial barrier function upon challenge with various harmful substances (e.g. cigarette smoke extract, allergens) in cultured primary respiratory tract epithelial cells. Furthermore we will assess changes in clinical parameters, cellular composition and inflammatory mediators.
Read the detailed description
The primary objective of the proposal is to investigate the effect of Tezepelumab on the epithelial barrier function of upper and lower airways. To that aim, epithelial cells from the upper and lower airways will be cultured to investigate the change in barrier function during Tezepelumab treatment in patients suffering from severe asthma in presence or absence of chronic rhinosinusitis with nasal polyps. In addition, mucus plugging will be quantified by computer tomography before and after Tezepelumab therapy. These data will be supplemented by cellular and mediator analyses as well as microbiome analyses. Thus, our study will unravel the molecular mechanisms and benefits underlying therapy with Tezepelumab in patients suffering from severe asthma with or without nasal polyps.
Objectives Primary objective: Effect of Tezepelumab treatment on the barrier function of upper and lower airways in patients suffering from severe asthma with and without CRSwNP. This will be achieved by analysis of epithelial barrier function upon challenge with various harmful substances (e.g. cigarette smoke extract, allergens, and rhinovirus) in cultured primary respiratory tract epithelial cells using the xCELLigence system for continuous monitoring of barrier function.
- Being tested
- Tezepelumab
- Keywords
- asthma, chronic rhinosinusitis with nasal polyps, tezepelumab, epithelial barrier, airways
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TezepelumabDrug
injection with Tezepelumab every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Asthma only | Active comparator | Patients suffering from asthma in absence of CRSwNP will be administerd tezepelumab every 4 weeks Receives: Drug: Tezepelumab |
| Asthma with CRSwNP | Active comparator | Patients suffering from Asthma with CRSwNP will be administered Tezepelumab every 4 weeks Receives: Drug: Tezepelumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cell index
Changes in normalized cell index in response to barrier-damaging substances in cultured primary epithelial cells of the different disease entities using the xCELLigence system for continuous monitoring of barrier function.
Measured: 6 months
Secondary outcomes (3)
Change in mucus plugging
The extent of air-trapping, bronchial wall thickening and mucus plugging per pulmonary segment will be scored independently by two thoracic radiologists.
Measured: 6 months
Change in marker expression immune cell subsets
Cellular composition and marker expression on cells derived from Bronchoalveolar lavage (BAL), nasal polyps and blood as assessed by a multi-colour mass cytometry panel
Measured: 6 months
Change in inflammatory mediators
(Inflammatory) mediator expression in BAL, lung tissue, nasal mucosa, polyp tissue (e.g. OLINK explorer)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start1 Oct 2025 (estimated)
- Primary completion31 Jan 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma BronchialeStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Idzko, Medical University of Vienna
- Investigators
- Marco Idzko, MD, PhD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07046117
- Sponsor's protocol ID
- Tezebarrier2025
- Acronym
- Tezebarrier
- Status last verified
- Jun 2025
- First submitted
- 5 Jun 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Scientific Data will be shared in public available databases
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tezepelumab on Barrier Function in Severe Asthmatic Patients With and Without Comorbid Chronic Rhinosinusitis With Nasal Polyps - an Exploratory Study
- ClinicalTrials.gov ID
- NCT07046117
- Acronym / sponsor ID
- Tezebarrier / Tezebarrier2025
- Keywords
- asthma, chronic rhinosinusitis with nasal polyps, tezepelumab, epithelial barrier, airways
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 1 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, we will investigate the effect of tezepelumab on the epithelial barrier function of the upper and lower airways in patients suffering from severe asthma with and without chronic rhinosinusitis with nasal polyps. This will be achieved by analysis of epithelial barrier function upon challenge with various harmful substances (e.g. cigarette smoke extract, allergens) in cultured primary respiratory tract epithelial cells. Furthermore we will assess changes in clinical parameters, cellular composition and inflammatory mediators.
Detailed description
The primary objective of the proposal is to investigate the effect of Tezepelumab on the epithelial barrier function of upper and lower airways. To that aim, epithelial cells from the upper and lower airways will be cultured to investigate the change in barrier function during Tezepelumab treatment in patients suffering from severe asthma in presence or absence of chronic rhinosinusitis with nasal polyps. In addition, mucus plugging will be quantified by computer tomography before and after Tezepelumab therapy. These data will be supplemented by cellular and mediator analyses as well as microbiome analyses. Thus, our study will unravel the molecular mechanisms and benefits underlying therapy with Tezepelumab in patients suffering from severe asthma with or without nasal polyps.
Objectives Primary objective: Effect of Tezepelumab treatment on the barrier function of upper and lower airways in patients suffering from severe asthma with and without CRSwNP. This will be achieved by analysis of epithelial barrier function upon challenge with various harmful substances (e.g. cigarette smoke extract, allergens, and rhinovirus) in cultured primary respiratory tract epithelial cells using the xCELLigence system for continuous monitoring of barrier function.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asthma only | Active comparator | Drug: TezepelumabPatients suffering from asthma in absence of CRSwNP will be administerd tezepelumab every 4 weeks |
| Asthma with CRSwNP | Active comparator | Drug: TezepelumabPatients suffering from Asthma with CRSwNP will be administered Tezepelumab every 4 weeks |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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:
Key exclusion criteria (4 listed)
- 1. 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 2. Pregnancy (as determined by urine pregnancy test) 3. Patients with severe anatomic variations or deviations that do not allow access to all areas in the nasal cavity or to perform bronchoscopy 4. Patients with any other confounding underlying lung disorder including but not limited to:
- 5. Patients with other causes of nasal polyps than Type 2 CRS inflammation 6. 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 7. Contraindications for endobronchial and/or transbronchial biopsy. 8. A mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study 9. Patients with clinically meaningful comorbidity as determined by the evaluating committee 10. Immunosuppressive treatment (e.g. cyclosporine) 11. Drug and alcohol abuse 12. Current smoker and former smokers if stopped smoking <6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tezepelumabinjection with Tezepelumab every 4 weeks | Drug | Asthma only, Asthma with CRSwNP |
Primary outcome
Change in cell index
Time frame: 6 months
Changes in normalized cell index in response to barrier-damaging substances in cultured primary epithelial cells of the different disease entities using the xCELLigence system for continuous monitoring of barrier function.
3 secondary outcomes
Change in mucus plugging
Time frame: 6 months
Change in marker expression immune cell subsets
Time frame: 6 months
Change in inflammatory mediators
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Individual participant dataSharing planned: Yes. Scientific Data will be shared in public available databases
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marco Idzko, MD, PhD principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tezepelumab in people with Asthma Bronchiale and Chronic Rhinosinusitis With Nasal Polyps (CRSwNP), run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julia Eckl-Dorna, MD, PhD (+43140400 ext. 34380, julia.eckl-dorna@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cell index (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.