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]).
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.
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.
Peters A. Randomized, controlled trial of exhalation delivery system with fluticasone for chronic rhinosinusitis without nasal polyps. Ann Allergy Asthma Immunol. 2022;125(5):S73. doi:10.1016/j.anai.2022.08.711
This article originally appeared on Pulmonology Advisor