VISUALIZE: a 24-week,open-label study using nasal endoscopy video to evaluate the efficacy and safety of EDS-FLU 186 μg twice daily in adults with bilateral nasal polyps

Abstract

Background: In prior phase 3, randomized, placebo-controlled trials, fluticasone propionate exhalation delivery system (EDS-FLU) over 24 weeks showed significant reduction in total polyp score compared with EDS-placebo. The goal of this study was to observe nasal endoscopy improvement(s) along with patient-reported symptoms associated with EDS-FLU administration over 24 weeks. Methods: This open-label, multicenter study enrolled adults with bilateral nasal polyp grade of ≥3 (out of 6), 22-Item Sino-Nasal Outcome Test (SNOT-22) scores ≥20, and previous sinus surgery. All patients received EDS-FLU 186 μg BID for 24 weeks. Nasal endoscopy was performed, and disease-specific quality of life and sense of smell were assessed with SNOT-22 and “Sniffin’ Sticks” at baseline, 3 months, and 6 months. An independent reviewer evaluated videos and performed blinded polyp grading and Lund-Kennedy (LK) assessments. Results: Eleven patients were enrolled. At baseline, mean polyp grade was 3.1/6. SNOT-22 scores were 48.8, and Sniffin’ Sticks measurements were 11.8/48. A clinically meaningful reduction in SNOT-22 was noted at 24 weeks. Olfaction improved by 4.7 points. The mean polyp grade was reduced from 3.1 to 2.4 at week 24. LK edema scores were reduced by 2.2. Conclusion: EDS-FLU 186 μg BID given over 24 weeks resulted in clinically meaningful reduction in SNOT-22 scores and polyp grade improvement in most subjects. Endoscopic documentation showed reduced inflammation and edema not adequately captured with polyp-scoring methodology.