NCT07046117

Effect of Tezepelumab on Barrier Function in Severe Asthmatic Patients With and Without Comorbid Chronic Rhinosinusitis With Nasal Polyps

Effect of Tezepelumab on Barrier Function in Severe Asthmatic Patients With and Without Comorbid Chronic Rhinosinusitis With Nasal Polyps - an Exploratory Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Asthma Bronchiale
• Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

Interventions

Type	Name	Description
DRUG	Tezepelumab	injection with Tezepelumab every 4 weeks

Timeline

• Start date: 2025-10-01
• Primary completion: 2028-01-31
• Completion: 2028-08-01
• First posted: 2025-07-01
• Last updated: 2025-07-01

Locations

1 site across 1 country: Austria