Novel Fluticasone Delivery Reduces Acute Exacerbation Risk in Chronic Rhinosinusitis

A novel exhalation delivery system for fluticasone treatment may improve antibiotic stewardship in patients with chronic rhinosinusitis.

Fluticasone use with a novel exhalation delivery system significantly reduces the risk for acute exacerbations among patients with chronic rhinosinusitis, according to study results presented at IDWeek 2022, held from October 19 to 23, in Washington, DC.

Chronic bouts of rhinosinusitis are associated with high rates of antibiotic use among adults. Approximately 70% of 10 million outpatient visits annually result in antibiotic use among adults with chronic rhinosinusitis.

The novel exhalation delivery system, XHANCE®, administers fluticasone above the inferior turbinate and directly into chronically inflamed sinonasal regions that are unreachable by standard nasal sprays.

Two randomized controlled trials were conducted to assess the efficacy of XHANCE fluticasone delivery for the prevention of acute exacerbations in patients with chronic rhinosinusitis. Patients were randomly assigned to receive either 1 (n=184) or 2 (n=183) nasal sprays of fluticasone per nostril or placebo (n=187) twice daily for 24 weeks. Pooled patient data captured from both trials were analyzed to determine the frequency of acute exacerbations. Acute exacerbations were defined as 3 days or more of worsening congestion/obstruction, rhinorrhea, facial pain/pressure, or hyposmia/anosmia requiring medical care escalation.

Among a total of 555 patients included in the analysis, 39.4% used standard nasal sprays prior to enrollment, and 38.8% previously underwent surgical sinus operations.

EDS-FLU is the first and only medication shown in randomized controlled trials to significantly reduce acute exacerbations of CRS.

During the 24-week study period, patients experienced 76 acute exacerbations of chronic rhinosinusitis, of which 71 required antibiotic treatment.

Compared with patients who received placebo, the incidence of acute exacerbations was significantly decreased among those who received fluticasone via XHANCE (incidence rate ratio [IRR], 0.39; P =.001). In addition, the decrease in acute exacerbation incidence was more significant among patients who received 2 sprays of fluticasone (IRR, 0.34; P =.002) compared with those who received 1 spray (IRR, 0.44; P =.012).

Overall, 15.7% of patients in the placebo group experienced 41 acute exacerbations, whereas 9.9% of those in the 1-spray fluticasone group experienced 20 exacerbations and 7.8% of those in the 2-spray group experienced 15 exacerbations.

Adverse events reported by at least 3% of patients included epistaxis, headache, nasopharyngitis, and COVID-19 infection. Epistaxis, headache, and COVID-19 occurred more commonly among patients in the 2-spray fluticasone group compared with both the 1-spray fluticasone and placebo groups. Nasopharyngitis, however, occurred more commonly among patients in the 1-spray fluticasone and placebo groups compared with those in the 2-spray group.

“EDS-FLU [exhalation delivery system-fluticasone] is the first and only medication shown in randomized controlled trials to significantly reduce acute exacerbations of CRS [chronic rhinosinusitis], offering potential to improve antibiotic stewardship by substantially reducing one of the most common drivers of outpatient antibiotic use,” researchers concluded.


Mahmoud R. Exhalation delivery system with fluticasone (EDS-FLU) significantly reduces acute exacerbations and associated antibiotic use in chronic rhinosinusitis. Presented at: IDWeek 2022; October 19-23; Washington, DC. Poster LB1581.