Dupilumab for Prevention of Recurrence of CRSwNP After ESS
Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
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.