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Effect of Dupilumab on nasal epithelial barrier function in patients with Chronic Rhinosinusitis with nasal polyps (CRSwNP) – an exploratory pilot study
EU CTIS ID: 2023-509815-10-00
What this study is testing
To characterize differences in barrier function of the nasal epithelium in patients suffering from CRSsNP or CRSwNP (in absence of therapy with monoclonal antibodies) and disease controls in response to challenges with various harmful substances in cultured primary nasal- and polyp-derived epithelial cells. Effect of dupilumab treatment on barrier function of the nasal epithelium in patients suffering from CRSwNP.
- 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
- 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)
You likely can't join if
- 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
See the full eligibility 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 for asthma or polyps will only be included if at least a washout period of 6 months has passed
- 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
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.
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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.