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Dupilumab for Prevention of Recurrence of CRSwNP After ESS
The investigators believe that administering Dupilumab during the pre- and peri-operative period of surgery for chronic rhinosinusitis with nasal polyps (CRSwNP) will safely downregulate Type 2 inflammation of the healing sinus environment and will allow for better coordinated and more effective mucosal healing. Specifically, the investigators believe that endoscopic signs and symptoms of recurrence will be reduced in the Dupilumab-treated group, and that this will be reflected in quality of life (QOL). Additionally, by reducing Type 2 inflammation at the time of surgery, Dupilumab may offer an additional benefit by decreasing operative bleeding. The investigators propose to perform a placebo-controlled, prospective, real-world trial in patients with CRSwNP undergoing revision surgery for CRSwNP to verify whether recurrences after endoscopic sinus surgery (ESS) can be prevented by controlling Type 2 inflammation during the peri-operative period using Dupilumab. A series of seven injections of Dupilumab (or placebo) will be administered to symptomatic patients undergoing ESS for CRSwNP. Beginning 4 weeks prior to surgery and continuing for 8 weeks post-surgery, q2 weekly injections will be administered to reduce Type 2 inflammation at time of ESS and during the post-operative recovery period. Principal outcome will be absence of recurrence of mucosal oedema of the sinus cavity as assessed by endoscopy. Secondary objectives will assess Polyp size, sinus symptomatology, quality of life, smell and asthma control. Exploratory analyses will assess microbiome and gene expression profiles to better understand molecular mechanisms implicated in CRSwNP pathophysiology, and to identify the pathways implicated by modulation of Type 2 inflammation.
Details
| Lead sponsor | Centre hospitalier de l'Université de Montréal (CHUM) |
|---|---|
| Phase | PHASE4 |
| Status | COMPLETED |
| Enrolment | 30 |
| Start date | Tue May 25 2021 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Tue Apr 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Chronic Rhinosinusitis With Nasal Polyps
Interventions
- Dupilumab 300 MG in 2 ML Prefilled Syringe
- Placebo
- Mometasone Furoate nasal spray
Countries
Canada