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Novel Medication Delivery System Benefits Postsurgical and Nonsurgical Patients with Chronic Rhinosinusitis with Nasal Polyps

by Linda Kossoff •

Is there a difference between treatment responses to the exhalation delivery system with fluticasone (EDS-FLU) in patients with chronic rhinosinusitis (CRS) with nasal polyps (CRSwNP) and recurrent symptoms after endoscopic sinus surgery (ESS) and the responses to EDS-FLU in patients without surgery?

BOTTOM LINE

Findings suggest that EDS-FLU reduces symptoms and improves quality of life in both patients with recurrent symptoms after sinus surgery and patients who have never had surgery.

BACKGROUND: Unlike standard nasally delivered sprays, the EDS-FLU uses a novel delivery system to create closed-palate, positive-pressure, bidirectional mechanics that alter the deposition of the topically acting anti-inflammatory medication.

STUDY DESIGN: Prospective study.

SETTING: Sacramento Ear, Nose, & Throat, Roseville, Calif.

SYNOPSIS: To evaluate the efficacy of EDS-FLU in patients with or without prior sinus surgery, researchers conducted two 24-week, prospective, randomized, double-blind, parallel-group, multicenter, EDS placebo-controlled trials involving adult patients with moderate to severe nasal congestion/obstruction and bilateral NPs. Of the total 482 patients included in the analysis, 154 reported a history of sinus surgery. Baseline characteristics were mostly similar for previously operated and unoperated patients across treatment groups. Patients were randomized into a 16-week double-blind phase including lower dose (one spray per nostril twice daily) and higher dose (two sprays per nostril twice daily) or EDS-placebo treatment arms, followed by an eight-week extension in which all patients received the higher dose. Data on both trials were pooled. Findings showed that patients with prior ESS and unoperated patients treated with EDS-FLU reported similar and substantial benefits as measured by multiple symptoms and quality-of-life/functioning outcomes and by nasal polyp grade. Study limitations included not all data informing on the immediate postsurgical period.

CITATION: Ow RA, Soler ZM, Sindwani R, et al. Efficacy of the exhalation polyps whose symptoms recur after sinus surgery. Int Forum Allergy Rhinol. 2023;13:31–41.