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TezeBarrier Study
EU CTIS ID: 2024-517538-16-00
What this study is testing
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.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
- Immunosuppressive treatment (e.g. cyclosporine)
- Drug and alcohol abuse
- 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
See the full eligibility criteria
- 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)
- 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
- Immunosuppressive treatment (e.g. cyclosporine)
- Drug and alcohol abuse
- 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 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 other causes of nasal polyps than Type 2 CRS inflammation
- 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
- Contraindications for endobronchial and/or transbronchial biopsy
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.