Fluticasone Propionate Exhalation Delivery System Effective for Rhinosinusitis

The study found FLU-EDS (372μg twice daily) to be 'well-tolerated'
The study found FLU-EDS (372μg twice daily) to be 'well-tolerated'

ATLANTA, GA—A fluticasone propionate exhalation delivery system (FLU-EDS) safely and effectively treats chronic rhinosinusitis in patients with nasal polyps (CRSwNP) or without polyps, according to findings from the Phase 3 safety and efficacy EXHANCE-III study, presented at the 2017 AAAAI Annual Meeting.

FLU-EDS (372μg twice daily) was “well-tolerated,” said lead study author Mandel Sher, MD, FAAAAI, of the Center for Cough, Largo, FL. “Significant improvements across a broad range of objective and subjective measures were measured in chronic rhinosinusitis patients with and without polyps.”

The exhalation delivery system (EDS) directs medications “deeper and more broadly” into the superior and posterior nasal cavity, the authors noted. This results in less medication loss than other nasal spray systems to swallowing or nasal drip, Dr. Sher noted. Improved EDS fluticasone delivery to the ostiomeatal complex “where sinus ostia drain and polyps originate,” he said.

The research team enrolled 706 patients in a multicenter, open-label study, of whom 102 had nasal polyps and 603 patients did not. Baseline Sino-Nasal Outcome Test 22 (SNOT-22) scores were 43.8 and 43.2 for patients with and without polyps. Most (92.3%) patients had previously used conventional intranasal steroids. More than a quarter (27.5%) had undergone surgery.

Among patients with Lund-Mackay edema scores higher than 0, a third (33.3%) of patients with nasal polyps and 54.8% of patients without polyps had “complete resolution,” Dr. Sher reported.

“SNOT-22 scores improved dramatically in patients with CRSwNP (-23.7) and without nasal polyps (-24.4),” Dr. Sher said. “More than 90% of patients reported improvement as assessed by PGIC [Patient Global Impression of Change], with >70% reporting 'much' or 'very much' improvements.”

Nasoendoscopy at last visit revealed that 48% of patients with CRSwNP saw an elimination of polyps in at least 1 nostril, the researchers found. Polyp grade had improved in 63% of these patients, with mean bilateral polyp scores dropping from 2.9 to 1.6. The number of these patients who were eligible for surgery dropped by 57% after therapy.

The FLU-EDS safety profile was “similar to traditional intranasal steroids,” Dr. Sher said.