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).
Key findings of the trial:
- In comparison to the EDS-placebo group, participants in both EDS-FLU groups experienced significantly less symptoms and sinus opacification (CSS least-square [LS] mean change: EDS-placebo, -0.81; EDS-FLU 186g, -1.54 [P<.05]; EDS-FLU 372g, -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]).
- In terms of secondary endpoints at week 24, both EDS-FLU groups significantly outperformed the placebo group on all measures (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).
- At least 3% of patients experienced adverse effects, which were more common in the FLU groups than the placebo group and happened more frequently in the COVID-19, epistaxis, depression, and headache groups.
EDS-FLU is the first and only medication to demonstrate benefit in a phase 3 trial in both symptoms and sinus opacification in chronic rhinosinusitis without nasal polyps, concluded the author.
REFERENCE
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
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