Chronic Rhinosinusitis With Nasal PolypsEpiBarNCT06398873
Effect of Dupilumab on Nasal Epithelial Barrier Function in Patients With CRSwNP
An observational study of Chronic Rhinosinusitis With Nasal Polyps and Chronic Rhinosinusitis Without Nasal Polyps, run by Medical University of Vienna at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Chronic Rhinosinusitis With Nasal Polyps, Chronic Rhinosinusitis Without Nasal Polyps
- What is being tested?
- Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]
- Type of treatment
- Injection or infusion
- How many people
- 80 participants
- Where
- 1 siteAustria
- Study dates
- 6 Jun 2024to 1 Sep 2027
- Phase
- Observational
- 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
Study population: Patients with chronic rhinosinusitis with and without nasal polyps
Who may be able to join
- 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
Who cannot join
- 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
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, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, Austria, A-1090
Julia Eckl-Dorna, MD, PhD, 004314040034380, julia.eckl-dorna@meduniwien.ac.at
Victoria Stanek, MA, victoria.stanek@meduniwien.ac.at
About this study
Official title: Effect of Dupilumab on Nasal Epithelial Barrier Function in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) - an Exploratory Pilot Study
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.
Read the detailed 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.
- Being tested
- Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]Drug
300mg/2 weeks
| Study group | Role | What they receive |
|---|---|---|
| CRSsNP | Not described | |
| CRSwNP | Dupilumab Receives: Drug: Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Barrier function in CRSsNP and CRSwNP
Cell index (xCELLigence)
Measured: 1 Visit (baseline)
Barrier function in CRSwNP with Dupilumab
Cell index (xCELLigence)
Measured: 3 Visits (baseline, 3 months, 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start6 Jun 2024
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Rhinosinusitis With Nasal PolypsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sven Schneider, MD, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06398873
- Sponsor's protocol ID
- EpiBar
- Acronym
- EpiBar
- Status last verified
- Jun 2024
- First submitted
- 25 Apr 2024
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be shared upon reasonable request
Publications
Bachert C, Han JK, Desrosiers M, Hellings PW, Amin N, Lee SE, Mullol J, Greos LS, Bosso JV, Laidlaw TM, Cervin AU, Maspero JF, Hopkins C, Olze H, Canonica GW, Paggiaro P, Cho SH, Fokkens WJ, Fujieda S, Zhang M, Lu X, Fan C, Draikiwicz S, Kamat SA, Khan A, Pirozzi G, Patel N, Graham NMH, Ruddy M, Staudinger H, Weinreich D, Stahl N, Yancopoulos GD, Mannent LP. Efficacy and safety of dupilumab in patients with severe chronic rhinosinusitis with nasal polyps (LIBERTY NP SINUS-24 and LIBERTY NP SINUS-52): results from two multicentre, randomised, double-blind, placebo-controlled, parallel-group phase 3 trials. Lancet. 2019 Nov 2;394(10209):1638-1650. doi: 10.1016/S0140-6736(19)31881-1. Epub 2019 Sep 19.
PubMed 31543428Schneider S, Poglitsch K, Morgenstern C, Quint T, Gangl K, Sinz C, Bartosik T, Campion NJ, Liu DT, Landegger LD, Tu A, Stanek V, Rocha-Hasler M, Bangert C, Eckl-Dorna J. Dupilumab increases aspirin tolerance in NSAID-exacerbated respiratory disease. Eur Respir J. 2023 Mar 16;61(3):2201335. doi: 10.1183/13993003.01335-2022. Print 2023 Mar.
PubMed 36549708
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dupilumab on Nasal Epithelial Barrier Function in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) - an Exploratory Pilot Study
- ClinicalTrials.gov ID
- NCT06398873
- Acronym / sponsor ID
- EpiBar / EpiBar
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 6 Jun 2024 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 3 May 2024 (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.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRSsNP | – | – |
| CRSwNP | – | Drug: Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]Dupilumab |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic rhinosinusitis with and without nasal polyps
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]300mg/2 weeks | Drug | CRSwNP |
Primary outcome
Barrier function in CRSsNP and CRSwNP
Time frame: 1 Visit (baseline)
Cell index (xCELLigence)
Barrier function in CRSwNP with Dupilumab
Time frame: 3 Visits (baseline, 3 months, 6 months)
Cell index (xCELLigence)
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 7 May 2025.
- Background: PubMed 31543428Bachert C, Han JK, Desrosiers M, Hellings PW, Amin N, Lee SE, Mullol J, Greos LS, Bosso JV, Laidlaw TM, Cervin AU, Maspero JF, Hopkins C, Olze H, Canonica GW, Paggiaro P, Cho SH, Fokkens WJ, Fujieda S, Zhang M, Lu X, Fan C, Draikiwicz S, Kamat SA, Khan A, Pirozzi G, Patel N, Graham NMH, Ruddy M, Staudinger H, Weinreich D, Stahl N, Yancopoulos GD, Mannent LP. Efficacy and safety of dupilumab in patients with severe chronic rhinosinusitis with nasal polyps (LIBERTY NP SINUS-24 and LIBERTY NP SINUS-52): results from two multicentre, randomised, double-blind, placebo-controlled, parallel-group phase 3 trials. Lancet. 2019 Nov 2;394(10209):1638-1650. doi: 10.1016/S0140-6736(19)31881-1. Epub 2019 Sep 19.
- Background: PubMed 36549708Schneider S, Poglitsch K, Morgenstern C, Quint T, Gangl K, Sinz C, Bartosik T, Campion NJ, Liu DT, Landegger LD, Tu A, Stanek V, Rocha-Hasler M, Bangert C, Eckl-Dorna J. Dupilumab increases aspirin tolerance in NSAID-exacerbated respiratory disease. Eur Respir J. 2023 Mar 16;61(3):2201335. doi: 10.1183/13993003.01335-2022. Print 2023 Mar.
- Individual participant dataSharing planned: No. IPD will be shared upon reasonable request
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Rhinosinusitis With Nasal Polyps and Chronic Rhinosinusitis Without Nasal Polyps, 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 7 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 7 May 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Barrier function in CRSsNP and CRSwNP (time frame: 1 Visit (baseline)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06398873, which also lists 2 linked publications.
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 7 May 2025.