Abstract
Objective: Chronic rhinosinusitis with polyposis is currently treated with intranasal steroids. The study objective was to assess the safety and effectiveness of a drug-eluting catheter to be inserted into the ethmoid sinuses to release triamcinolone during FESS in patients with sinonasal polyposis.
Methods: Preliminary results from a prospective, randomized, double blinded, clinical trial enrolling 40 patients. In every case, after polypectomy was done to expose the ethmoid bulla, a drug-eluting catheter to deliver triamcinolone (0.3 mL) was randomly applied to one nasal fossa, whereas the other was treated by conventional functional endoscopic sinus surgery. Outcome measures were visual analogue scales, RSDI, endoscopy, and olfactometry assessment at baseline and 3 months. Safety assessment included ocular exams at baseline and 30 days.
Results: After randomization was performed, unilateral devices were successfully placed in all patients, and they were also easily removed after 4 weeks. When comparing both nasal fossae, mean inflammation scores were minimal at all time points. At 3 months, the prevalence of polypoid edema, adhesions and rhinorrhea was statistically similar in both sides. Changes from baseline in patient-reported outcomes were statistically significant (P < .0001). No clinically significant changes from baseline in intraocular pressure occurred. CT imaging will be done after 12 months of follow-up.
Conclusion: This randomized controlled trial provides clinical evidence of the safety, effectiveness, and clinical utility of a drug-eluting catheter in patients with nasal polyposis.
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