Randomized, controlled trial of exhalation delivery system with fluticasone for chronic rhinosinusitis without nasal polyps
Abstract
Introduction: There are no FDA-approved medications for the >20 million chronic rhinosinusitis patients without nasal polyps. The Exhalation Delivery System with Fluticasone (EDS-FLU) is an intranasal steroid in a device that delivers drug to regions above the inferior turbinate and behind the nasal valve. Method(s): In this phase 3, 24-week, randomized, controlled trial evaluating EDS-FLU versus EDS-placebo twice daily in chronic sinusitis without polyps, co-primary endpoints were combined symptom score (CSS;week 4) and average of percentages of CT-opacified volume across ethmoid/maxillary sinuses (APOV;week 24). Other outcomes included Quality-of-Life (SNOT-22, SF-36), Sleep (PSQI), and Patient-reported Global Impression of Change (PGIC). Result(s): Baseline scores suggest moderate-severe disease: mean CSS=6.0;APOV=62.0%. Both EDS-FLU doses [186microg (n=74) and 372microg (n=74)] significantly reduced both symptoms and sinus opacification versus EDS-placebo (n=75): CSS least-square (LS) mean change, EDS-placebo, -0.81;EDS-FLU 186microg, -1.54 (p=3% of patients and >EDS-placebo) were COVID-19, epistaxis, headache, and depression. Conclusion(s): 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. Copyright © 2022
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 145 participants or records.
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