Exhalation Delivery System With Fluticasone Improves Sinusitis Without Polyps

The exhalation delivery system with fluticasone (EDS-FLU) improved symptoms and sinus opacification in patients with chronic rhinosinusitis without nasal polyps according to phase 3 trial findings presented at the American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting, held from November 10 to 14, in Louisville, Kentucky.

The EDS-FLU delivers an intranasal steroid to regions above the inferior turbinate and behind the nasal valve. Researchers conducted a phase 3 randomized controlled trial to investigate the characteristics of the EDS-FLU in patients with chronic rhinosinusitis without nasal polyps.

The primary study outcomes were combined symptom score (CSS) at week 4 and the average of percentages of computer tomography (CT)-opacified volume across ethmoid/maxillary sinuses (APOV) at week 24. Secondary endpoints included: (1) quality-of-life, as measured by the Sino-Nasal Outcome Test (SNOT-22), Short Form 36 (SF-36); (2) sleep, as measured by the Pittsburgh Sleep Quality Index (PSQI); (3) and patient-reported global impression of change (PGIC).

The study included 223 patients with moderate-severe disease based on baseline scores (mean CSS=6.0; APOV=62.0%). Participants were divided into 3 groups, 2 with varying dose levels of EDS-FLU (186µg, n=74; 372µg, n=74), and an EDS-placebo group (n=75). Participants in both of the EDS-FLU groups had significantly reduced symptoms and sinus opacification compared with those in the EDS-placebo group (CSS least-square [LS] mean change: EDS-placebo, -0.81; EDS-FLU 186µg, -1.54 [P <.05]; EDS-FLU 372µg, -1.74 [P <.001]; APOV LS mean change: EDS-placebo, 1.19: EDS-FLU 186µg, -7.00 [P <.001]; EDS-FLU 372µg, -5.14 [P <.01]).

With respect to secondary endpoints at week 24, the researchers found measures were significantly improved for both EDS-FLU groups vs the placebo group (SNOT-22 LS mean change: -17.5 vs -8.7, respectively; P =.001; PSQI global score LS mean change: -1.54 vs -0.33, respectively; P <.001; and PGIC much/very much improved: 60% vs 25%, respectively; P <.001).

Adverse events, including COVID-19, epistaxis, depression, and headache, occurred in at least 3% of patients and were greater in the FLU groups than in the placebo group.

Researchers concluded that “EDS-FLU is the first and only drug to show improvement in a phase 3 trial in both symptoms and sinus opacification in chronic rhinosinusitis without nasal polyps.”