Photo Credit: Dragana991

The following is a summary of “Efficacy of EDS-FLU for Chronic Rhinosinusitis: Two Randomized Controlled Trials (ReOpen1 and ReOpen2),” published in the April 2024 issue of Allergy & Immunology by Palmer, et al.

Chronic rhinosinusitis (CRS) is a prevalent inflammatory condition. Despite its high prevalence, no medications are approved by the Food and Drug Administration (FDA) specifically for the most common form of CRS, known as CRS, without nasal polyps or chronic sinusitis. The Exhalation Delivery System for fluticasone (EDS-FLU; marketed as XHANCE) employs novel biomechanics to deliver fluticasone to sinonasal areas above the inferior turbinate, targeting sinus drainage pathways that are typically not reached by standard-delivery nasal sprays. For a study, researchers sought to evaluate the efficacy of EDS-FLU for CRS, regardless of the presence of nasal polyps.

Two randomized, placebo-controlled trials, ReOpen1 and ReOpen2, were conducted involving adults with CRS, with or without nasal polyps. The trials were conducted across 120 sites in 13 countries. Patients received either EDS-FLU (1 or 2 sprays/nostril) or EDS-placebo twice daily for 24 weeks. The coprimary outcome measures were the composite symptom score through week 4 and the percent opacification of the ethmoid/maxillary sinuses assessed by computed tomography at week 24.

In ReOpen1 (N = 332), the least-squares mean change in composite symptom score for EDS-FLU (1 or 2 sprays/nostril) versus EDS-placebo was -1.58 and -1.60 versus -0.62 (P < .001, P < .001), respectively. In ReOpen2 (N = 223), the corresponding values were -1.54 and -1.74 versus -0.81 (P = .011, P = .001). Regarding sinus opacification, in ReOpen1, the least-squares mean change for EDS-FLU versus EDS-placebo was -5.58 and -6.20 versus -1.60 (P = .045, P = .018), respectively. In ReOpen2, the values were -7.00 and -5.14 versus +1.19 (P < .001, P = .009). EDS-FLU reduced acute disease exacerbations by 56% to 66% compared to EDS-placebo (P = .001). Patients using standard-delivery nasal steroid products before the study showed significant symptom reductions of similar magnitude (P < .001). Adverse events were similar to those reported with standard-delivery intranasal steroids.

EDS-FLU was the first nonsurgical treatment shown in two independent randomized clinical trials to alleviate symptoms, reduce intrasinus opacification, and decrease exacerbations in patients with CRS, regardless of polyp status.

Reference: jaci-inpractice.org/article/S2213-2198(23)01365-X/fulltext