Effect of Dupilumab on Nasal Epithelial Barrier Function in Patients With CRSwNP

Chronic Rhinosinusitis With Nasal Polyps Clinical Trial

— EpiBar  

Official title:

Effect of Dupilumab on Nasal Epithelial Barrier Function in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) - an Exploratory Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06398873
• Other study ID #: EpiBar
• Status: Recruiting
• Start date: June 6, 2024
• Est. completion date: September 1, 2027

Study information

• Verified date: June 2024
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The investigators aim to investigate two major so far unresolved topics in CRSwNP research: (1) Thorough functional and molecular characterisation of barrier function in patients suffering from CRSsNP and CRSwNP and (2) effect of dupilumab treatment on barrier function in polyp patients. This will be achieved in patient-derived samples by employing measurement of barrier function in primary cell cultures in combination with a mass cytometry based imaging approach, transcriptomic analysis as well as cytokine and microbiome data of individual patients.

Description:

Primary objective 1: Characterization of differences in barrier function of the nasal epithelium in patients suffering from CRSsNP, CRSwNP with and without asthma or N-ERD (in absence of therapy with monoclonal antibodies). T Primary objective 2: Effect of dupilumab treatment on barrier function of the nasal epithelium in patients suffering from CRSwNP with and without asthma or N-ERD.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 1, 2027
• Est. primary completion date: September 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• 18-99 years of age

• Willingness to participate in the study

• Suffer from chronic rhinosinusitis defined as in EPOS 2020 criteria, see main text

• Group 1 (n=20, CRSsNP): Absence of nasal polyps

• Group 2 (N=60, CRSwNP): Presence of nasal polyps as confirmed by endoscopy or CT and planned therapy with dupilumab

• Presence or absence of non-steroidal anti-inflammatory drug (NSAID)-Exacerbated Respiratory Disease (N-ERD)

• Patients with a history of treatment with monoclonal antibodies will only be included if at least a washout period of 6 months has passed

Exclusion Criteria:

• Pregnancy (as determined by ß-HCG test) or breast feeding

• Patients with severe anatomic variations or deviations that do not allow access to all areas in the nasal cavity

• Patients with cystic fibrosis or primary ciliary dyskinesia

• Patients with permanent immunosuppression

• 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

• Patients with a history of exacerbation of chronic rhinosinusitis 4 weeks prior to the screening visit

• Intake of a burst of systemic corticosteroids for the treatment of CRS 4 weeks prior to the screening visit

Related Conditions & MeSH terms

• Chronic Rhinosinusitis With Nasal Polyps
• Chronic Rhinosinusitis Without Nasal Polyps
• Nasal Polyps
• Polyps
• Rhinosinusitis
• Sinusitis

Intervention

Drug:
• Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]
300mg/2 weeks

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Barrier function in CRSsNP and CRSwNP	Cell index (xCELLigence)	1 Visit (baseline)
Primary	Barrier function in CRSwNP with Dupilumab	Cell index (xCELLigence)	3 Visits (baseline, 3 months, 6 months)