Efficacy of the exhalation delivery system with fluticasone in patients with chronic rhinosinusitis with nasal polyps whose symptoms recur after sinus surgery

Background: Sinus surgery removes inflamed tissue, restores airflow, and improves delivery of medication into surgically opened spaces. The exhalation delivery system with fluticasone (EDS-FLU; XHANCE (R)) uses a novel delivery system to create closed-palate, positive-pressure, bidirectional mechanics that significantly alter the deposition of the topically acting anti-inflammatory medication. We ask whether EDS-FLU efficacy differs for patients with recurrent symptoms after sinus surgery versus patients without surgery. Objective: We aimed to compare EDS-FLU treatment responses in patients with recurrent symptoms after endoscopic sinus surgery (ESS) and patients who have never had sinus surgery. Methods: Data were pooled from two large, controlled trials (NAVIGATE I and II) for exploratory analyses. Chronic rhinosinusitis symptoms, polyp grade, and quality-of-life measures were compared between patients with prior ESS and those without prior ESS. Results: Patients with prior ESS (exhalation delivery system-placebo [n = 53], EDS-FLU186 mu g [n = 52], and EDS-FLU372 mu g [n = 49]) and unoperated patients (exhalation delivery system-placebo [n = 108], EDS-FLU 186 mu g [n = 108], and EDS-FLU 372 mu g [n = 111]) treated with EDS-FLU reported similar and substantial benefits as measured by multiple symptom and quality-of-life/functioning outcomes (congestion score, 22-Item Sinonasal Outcomes Test [SNOT-22], Rhinosinusitis Disability Index [RSDI], Patient Global Impression of Change) and by nasal polyp grade. In previously operated patients, unlike surgery-naive patients, multiple outcomes (SNOT-22, RSDI, polyp grade) consistently showed numerically but not statistically greater responses to the higher dose. Conclusions: Patients with recurrent symptoms after sinus surgery who were treated with EDS-FLU demonstrated significant symptom and quality-of-life improvement. Unlike unoperated patients, patients with prior ESS had a numerically but not statistically greater response to the higher dose of EDS-FLU (two sprays per nostril twice a day).