Two controlled trials find EDS-FLU (Xhance®) first medication effective for chronic sinusitis (with or without polyps)

Published: January 18, 2024

Chronic sinusitis (also called “chronic rhinosinusitis”; CRS) affects up to ≈31 million adults in the United States, predisposes to frequent acute sinusitis exacerbations that worsen quality of life and disease control, can worsen asthma control, and leads to significant healthcare costs. CRS may be the most common reason for adult outpatient antibiotic use, with ≈70% of ≈10 million outpatient visits each year resulting in antibiotic prescriptions. Although several medications, including EDS-FLU, have been previously approved by the FDA to treat the minority of patients who have nasal polyps (CRS with nasal polyps), no medication has ever been approved for most CRS patients, who do not have nasal polyps. The novel biomechanics of the exhalation delivery system (EDS) enable delivery of fluticasone (EDS-FLU; XHANCE®) into sinuses and sinus drainage pathways not reached by standard-delivery prescription or over-the-counter nasal sprays.

In a recent study in The Journal of Allergy and Clinical Immunology: In Practice, Palmer et al. report results from two randomized, placebo–controlled trials in adults with CRS irrespective of polyps (ReOpen1) or exclusively without polyps (ReOpen2). Patients received EDS-FLU (1 or 2 sprays/nostril), or EDS-placebo, twice daily for 24 weeks. Coprimary measures included change in core symptoms of CRS through week 4 (composite symptom score) and change in sinus CT scans (ethmoid/maxillary sinus opacification) after week 24. Other pre-specified and statistically controlled outcomes included the frequency of acute exacerbations and symptom improvement for the subset of patients who had persistent symptoms despite actively using a standard-delivery nasal steroid before entering the trial (most commonly, standard fluticasone or mometasone nasal spray).  

Chronic sinusitis symptoms improved significantly with EDS-FLU in both ReOpen1 (N=332) and ReOpen2 (N=223). Combined symptom score improvement ranged from −1.58 (2 sprays) to −1.60 (1 sprays) vs −0.62 for placebo in ReOpen1 (both P<0.001) and −1.54 (2 sprays) to −1.74 (1 spray) vs -0.81 in ReOpen2 (P=0.011, P=0.001). Sinus CT scans also improved significantly with EDS-FLU in both studies, with reduced opacification inside the ethmoid/maxillary sinuses. Acute disease exacerbations (mostly requiring antibiotics) were reduced by 56-66% for patients using EDS-FLU compared with EDS-placebo (P=.001). Symptoms were also significantly improved, and to a similar degree, in study patients who had persistent symptoms on standard-delivery nasal steroids before the trial (P<.001). Adverse events were similar to conventional standard-delivery nasal steroid sprays.

This is the first controlled-trial evidence that a nonsurgical treatment can improve symptoms, sinus opacification, and acute exacerbations for patients with CRS with or without nasal polyps, including patients whose symptoms persist despite use of standard-delivery nasal steroids.

The Journal of Allergy and Clinical Immunology: In Practice is an official journal of the AAAAI, focusing on practical information for the practicing clinician.

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