Symptom burden and quality of life in CRSwNP significantly improved with novel fluticasone delivery system
Patients with chronic rhinosinusitis with nasal polyps (CRSwNP) who had never had surgery or whose symptoms recur after endoscopic sinus surgery had similar significant benefits in terms of quality of life (QOL) and burden of symptoms when they received an exhalation system with fluticasone.
Significant improvement in symptoms and quality of life (QOL) was associated with an exhalation system with fluticasone (EDS-FLU) in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) who had never undergone surgery or whose symptoms return after endoscopic sinus surgery (ESS), according to the results of a study published in the International Allergy and Rhinology Forum.
For preoperative and postoperative patients with CRSwNP, clinical guidelines recommend the use of topically administered glucocorticoids, although most patients report inadequate symptom relief with the drug.
Using a novel delivery system to create bidirectional positive pressure, closed palate mechanisms that significantly alter fluticasone deposition, FDA-approved EDS-FLU (XHANCE) has been shown in previous research to reduce the severity of nasal polyps in lens and patient. -reported measurements.
“An unanswered question is whether outcomes with EDS-FLU differ for patients whose anatomy has been surgically altered,” the authors of the current study wrote. “A recently published consensus treatment algorithm for evidence-based, stepwise management of CRSwNP recommends the use of EDS-FLU prior to escalation of care to sinus surgery and also as an option for post-surgical medical management, but trial data have not been published separately evaluating non-operated patients versus those who have had prior surgery.
They performed a pooled analysis of symptoms, quality of life and polyp grade outcomes from the NAVIGATE I (NCT01622569) and II (NCT01624662) randomized, controlled, double-blind, 24-week trials to assess the efficacy of EDS-FLU in patients with CRSwNP with recurrence of symptoms after surgery, and to compare the results with non-operated patients.
Outcome measures assessed included mean change from baseline to week 16 in nasal congestion scores, mean change from baseline to week 24 in the Sino-Nasal Outcome Test (total score and SNOT- 22), mean change from baseline in Rhinosinusitis Disability Index (RSDI) total score and subscales at week 16, patient global impression of change (PGIC) scores at week 16 and mean change from baseline to week 24 in bilaterally summed NP grade.
Of 482 patients included in the analysis, approximately one-third (n=154) reported a history of sinus surgery at study entry, the average number of prior surgeries per patient in the prior surgery group being 1.6.
Patients with prior ESS (EDS-placebo, n=53; EDS-FLU 186 mcg, n=52; EDS-FLU 372 mcg, n=49) and non-operated patients (EDS-placebo, n=108; EDS-FLU 186 mcg, n=108; EDS-FLU 372 mcg, n=111) treated with EDS-FLU reported similar and significant benefits at 16 weeks for mean congestion scores, mean RSDI total score, and PGIC, and at 24 weeks for SNOT-22 and Grade NP.
Notably, several results (SNOT-22, RSDI, polyp grade) consistently showed numerically but not statistically greater responses to the higher dose of EDS-FLLU in previously operated patients, which was not found in surgery-naïve patients.
“Given the risks and benefits, EDS-FLU is an important treatment option, especially for patients without an adequate response to standard topical nasal steroids, at multiple points in a stepwise care algorithm, including as a as medical treatment before sinus surgery and for maintenance treatment or recurrent symptoms after surgery,” the researchers concluded.
Ow RA, Soler ZM, Sindwani R, et al. Effectiveness of the expiratory delivery system with fluticasone (EDS-FLU) in patients with chronic rhinosinusitis with nasal polyps whose symptoms recur after sinus surgery. Int Rhinol Allergy Forum. Published online June 8, 2022. doi:10.1002/alr.23043