Symptom Burden, QOL in CRSwNP Significantly Improved With Novel Fluticasone Delivery System

Significant symptom and quality of life (QOL) improvement was associated with an exhalation system with fluticasone (EDS-FLU) in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) who are surgery-naive or whose symptoms recur after endoscopic sinus surgery (ESS), according to study findings published in the International Forum of Allergy & Rhinology.

For presurgery and postsurgery patients with CRSwNP, clinical guidelines recommend the use of topically delivered glucocorticoids, despite most patients reporting inadequate symptom relief with the medication.

Using a novel delivery system to create closed-palate, positive-pressure, bidirectional mechanics that significantly alter the deposition of fluticasone, the FDA-approved EDS-FLU (XHANCE) has been shown in prior research to reduce nasal polyp severity in objective and patient-reported measures.

“A question not yet answered is whether results with EDS-FLU differ for patients with surgically altered anatomy,” wrote the authors of the current study. “A recently published consensus treatment algorithm for evidence-based, stepwise management of CRSwNP recommends use of EDS-FLU prior to escalating care to sinus surgery and also as an option for post-surgical medical management, but trial data have not been published separately evaluating unoperated patients vs those with prior surgery.”

They conducted an analysis of pooled symptom, QOL, and polyp grade outcomes data from the NAVIGATE I (NCT01622569) and II (NCT01624662) randomized, controlled, double-blind, 24-week trials to evaluate the efficacy of EDS-FLU in patients with CRSwNP with symptom recurrence after surgery, and to compare results with unoperated patients.

Outcome measures assessed included the mean change from baseline through week 16 in nasal congestion scores, mean change from baseline through week 24 in the Sino-Nasal Outcome Test (SNOT-22 total score and subscales), 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 through 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, with the mean number of prior surgeries per patient in the prior-surgery group reported as 1.6.

Patients with prior ESS (EDS-placebo, n = 53; EDS-FLU 186 mcg, n = 52; EDS-FLU 372 mcg, n = 49) and unoperated 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 in mean congestion scores, mean RSDI total score, and PGIC, and at 24 weeks in SNOT-22 and NP grade.

Notably, multiple outcomes (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-naive patients.

“Considering risk and benefit, EDS-FLU is an important therapeutic option, particularly for patients without adequate response to standard topical nasal steroids, at several points in a stepwise care algorithm, including as medical therapy prior to sinus surgery, and for maintenance treatment or recurrent symptoms following surgery,” the researchers concluded.

Reference

Ow RA, Soler ZM, Sindwani R, et al. Efficacy of the exhalation delivery system with fluticasone (EDS-FLU) in patients with chronic rhinosinusitis with nasal polyps whose symptoms recur after sinus surgery. Int Forum Allergy Rhinol. Published online June 8, 2022. doi:10.1002/alr.23043