EDS-FLU improved symptoms, sinus opacification, acute exacerbations in two randomized trials in adults with chronic rhinosinusitis
By Elana Gotkine HealthDay Reporter
FRIDAY, Jan. 26, 2024 (HealthDay News) — For patients with chronic rhinosinusitis (CRS), an exhalation delivery system that delivers fluticasone (EDS-FLU) to sinonasal areas above the inferior turbinate is efficacious, irrespective of nasal polyps, according to a study published online Jan. 18 in the Journal of Allergy and Clinical Immunology: In Practice.
James N. Palmer, M.D., from the University of Pennsylvania Perelman School of Medicine in Philadelphia, and colleagues examined EDS-FLU efficacy for CRS in two randomized, EDS-placebo-controlled trials in adults with CRS irrespective of polyps (ReOpen1; 332 patients) or exclusively without polyps (ReOpen2; 223 patients). For 24 weeks, patients received EDS-FLU one or two sprays/nostril or EDS-placebo twice daily.
The researchers found that the composite symptom score least-squares mean change for EDS-FLU one or two sprays/nostril versus EDS-placebo was −1.58 and −1.60 versus −0.62 in ReOpen1, and −1.54 and −1.74 versus −0.81 in ReOpen2. Sinus opacification least-squares mean change for one or two sprays/nostril of EDS-FLU versus EDS-placebo was −5.58 and −6.20 versus −1.60 in ReOpen1 and −7.00 and −5.14 versus +1.19 in ReOpen2. Compared with EDS-placebo, acute disease exacerbations were reduced by 56 to 66 percent with EDS-FLU. For patients using standard-delivery nasal steroid products just before entering the study, there were significant symptom reductions of a similar magnitude observed. Similar adverse events were seen to those with standard-delivery intranasal steroids.
“These findings provide strong evidence for an effective, noninvasive treatment option for people who continue to experience symptoms after over-the-counter medications have failed,” Palmer said in a statement.
Several authors disclosed ties to pharmaceutical companies, including OptiNose US, which funded the study.
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