EDS device with fluticasone cuts CRS exacerbations

The use of an exhalation delivery system with fluticasone (EDS-FLU) significantly reduces acute exacerbations of chronic rhinosinusitis (CRS), which may help drive down the need for antibiotics and prevent antibiotic resistance, in the ReOpen1 and 2 randomized controlled trials.

There was a 61-percent reduction in acute exacerbations of CRS (incidence rate ratio [IRR], 0.39; p=0.001) with the EDS-FLU vs placebo, reported Dr Ramy Mahmoud, president and CEO of Optinose, the maker of the system, during a late-breaking presentation at IDWeek 2022.  

Reductions were greater with the higher dose (two sprays per nostril twice daily; IRR, 0.34; p=0.002) vs the lower dose (one spray per nostril twice daily; IRR,0.44; p=0.012).

Overall, there were 15 exacerbations in the high-dose group vs 20 in the low-dose group compared with 41 in the placebo group.

“EDS-FLU is the first and only medication shown in randomized controlled trials to significantly reduce acute exacerbations of CRS, offering the potential to improve antibiotic stewardship by substantially reducing one of the most common drivers of outpatient antibiotic use,” Mahmoud pointed out.

The EDS device has three prongs – one is held in the mouth and the other two go into each nostril. Patients would have to exhale through the port in the mouth, effectively forcing fluticasone into the chronically inflamed sinonasal regions not typically reached by standard nasal sprays.

Acute exacerbations of CRS are common in the US, prompting 10 million doctor visits each year. Seventy percent of cases result in outpatient antibiotic use.

“What is unique about the study is that we included patients with chronic sinusitis, which had not a lot of agents studied specifically for this condition,” commented co-author Dr Zachary Soler from the Medical University of South Carolina in Charleston, South Carolina, US.  “This was targeted specifically to patients with chronic sinusitis who do not have nasal polyps.”

ReOpen 1 and ReOpen 2 trials included 555 patients with chronic rhinosinusitis who were randomly assigned to EDS-FLU one or two sprays per nostril or placebo twice daily for 24 weeks. The frequency of acute exacerbations of CRS was defined as worsening of at least one cardinal symptom of CRS (nasal congestion/obstruction, rhinorrhoea, facial pressure or pain, hyposmia/anosmia for ≥3 days, requiring doctor visit, antibiotic or steroid prescription. Data from the two trials were pooled for analysis. [IDWeek 2022, abstract LB1581]

Of the number, 39.4 percent were using standard nasal steroids at study entry and 38.8 percent had prior sinus surgery. Over 24 weeks, 76 acute exacerbations occurred, with 71 requiring antibiotic use.

The treatment was well tolerated. Adverse events were reported in over 3 percent of patients, with epistaxis, COVID-19 infection, headache, and nasopharyngitis more common with EDS-FLU than with placebo.

The EDS-FLU device, once approved by the US FDA, can overcome the inherent limitations of standard nasal delivery devices and offer clinical benefits to patients with CRS.