Status:
WITHDRAWN
Early-onset Dupilumab Effects in CRSwNP
Lead Sponsor:
University of Rochester
Conditions:
Chronic Rhinosinusitis With Nasal Polyps
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
While it is known that Dupilumab has profound effects in patients with CRSwNP, these are often seen months later after treatment initiation; however, in practice, patients often endorse feeling signif...
Detailed Description
This is a single center, prospective, controlled pilot study investigating the acute-onset changes across multiple parameters from immunology to microbiome and pulmonary physiology in patients with CR...
Eligibility Criteria
Inclusion
- Patients age 18+
- who in normal clinical practice would be a candidate for dupilumab.
- with a diagnosis of CRSwNP including
- at least 2 of the following symptoms on screening:
- nasal blockade/obstruction/congestion or nasal discharge;
- facial pain/pressure;
- reduction or loss of smell
Exclusion
- \> 80 years of age
- prior history of immunotherapy use (including prior participation in dupilumab or other clinical trials)
- Treatment with systemic corticosteroids, monoclonal antibodies, immunosuppressive treatments or anti-IgE therapy during the past two months prior to trial participation.
- CRS without polyps or another non-nasal polyposis condition
- Patients with conditions/concomitant diseases making them ineligible for evaluation of the primary efficacy endpoint such as: acute sinusitis/nasal infection or upper respiratory infection at day of screening or in the two weeks prior to screening, Churg-Strauss syndrome, Young's syndrome, Kartagener's syndrome or dyskinetic ciliary syndromes, concomitant cystic fibrosis, CT scan suggestive of allergic fungal rhinosinusitis
- Patients with comorbid asthma if they had a recent asthma exacerbation requiring systemic (oral and/or parenteral) steroid treatment or hospitalization for \>24h for treatment of asthma, within 3 months prior to screening or are on a dose of greater than 1000 ug fluticasone or an equivalent inhaled corticosteroid.
Key Trial Info
Start Date :
June 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2027
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06188871
Start Date
June 1 2024
End Date
June 1 2027
Last Update
May 9 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Rochester Department of Otolaryngology Head and Neck Surgery
Rochester, New York, United States, 14642