Fluticasone Exhalation Delivery System Aids Sinusitis without Polyps

CHICAGO: Findings from a phase 3 trial published in Annals of Allergy, Asthma & Immunology showed that the exhalation delivery system with fluticasone (EDS-FLU) reduced symptoms and sinus opacification in those with chronic rhinosinusitis who did not have nasal polyps.

For more than 20 million people who suffer from chronic rhinosinusitis but don't have nasal polyps, there are no FDA-approved drugs. The Exhalation Delivery System with Fluticasone (EDS-FLU) is an intranasal steroid in a device that delivers medication to areas above the inferior turbinate and behind the nasal valve.

Considering patients with chronic rhinosinusitis who lacked nasal polyps, the investigator carried out a phase 3 randomized controlled study to examine the properties of the EDS-FLU.

Co-primary objectives were the combined symptom score (CSS; week 4) and the average of percentages of CT-opacified volume throughout ethmoid/maxillary sinuses (APOV; week 24) in this phase 3, 24-week, randomized, controlled trial comparing EDS-FLU to EDS-placebo twice daily in chronic sinusitis without polyps. The trial comprised 223 patients with moderate-severe disease based on baseline scores (mean CSS=6.0; APOV=62.0%). Other outcomes were Quality-of-Life (SNOT-22, SF-36), Sleep (PSQI), and Patient-reported Global Impression of Change (PGIC). Two sets of participants received varied doses of EDS-FLU (186 g, n=74; 372 g, n=74), and a third group of participants received an EDS-placebo (n=75).