麻豆传媒

WASHINGTON -- Use of an exhalation delivery system with fluticasone (EDS-FLU; Xhance) significantly reduced acute exacerbations of chronic rhinosinusitis, which may drive down the need for antibiotics, an analysis of two randomized controlled trials showed.

Compared with placebo, treatment with the EDS-FLU led to a 61% reduction in acute exacerbations of chronic rhinosinusitis (incidence rate ratio [IRR] 0.39, P=0.001), reported Ramy Mahmoud, MD, MPH, president and CEO of Optinose, the maker of the system, during a late-breaking presentation at IDWeek.

Reductions were greater with the higher dose (two sprays per nostril twice a day) compared with the lower dose (one spray per nostril twice a day), he said (P=0.002 and P=0.012, respectively).

Overall, 20 exacerbations were reported in the low-dose group versus 15 in the high-dose group. Among those on placebo, 41 exacerbations occurred, Mahmoud reported.

"The exhalation delivery system with fluticasone is the first and only medication shown in randomized controlled trials to significantly reduce acute exacerbations of chronic rhinosinusitis, offering the potential to improve antibiotic stewardship by substantially reducing one of the most common drivers of outpatient antibiotic use," he concluded.

He explained that the device has three prongs -- one prong goes into each nostril, and the third is held in the mouth. The patients exhale through the port in the mouth, which forces fluticasone into the upper reaches of the nose more effectively than nasal sprays.

Co-author Zachary Soler, MD, of the Medical University of South Carolina in Charleston, told 麻豆传媒 that "what is unique about this study is that it includes patients with chronic sinusitis, which is a disease that really hasn't had a whole lot of study of agents specifically for it. This was targeted specifically for patients with chronic sinusitis who don't have nasal polyps."

He noted that the goal of the study was to not only help patients feel better, but also to see whether there was objective relief in the sinuses using imaging. "The answer was the patients do feel better, and their CT scans look better as well."

"In an acute exacerbation, a patient suddenly feels worse. In my clinic, I saw five patients today who said, 'Doctor, over the last 10 days I have felt significantly worse due to my chronic sinusitis. I have been having more symptoms,'" he said. "So, the question was whether using this medication and device reduces the frequency of that, and, in fact, we saw a 60% reduction in acute exacerbations in the 24-week study."

In the ReOpen 1 and ReOpen 2 trials, patients with chronic rhinosinusitis were randomized to the lower dose of the EDS-FLU, the higher dose of the EDS-FLU, or placebo. Frequency of acute exacerbation of chronic rhinosinusitis was defined as worsening of at least one cardinal symptom of the disease (nasal congestion/obstruction, rhinorrhea, facial pressure or pain, or hyposmia/anosmia) for at least 3 days, requiring escalation of medical care, such as a doctor visit, or antibiotic or steroid prescription. Data from the two trials were pooled for the current analysis.

The studies included 555 patients; 39.4% were using standard nasal steroids at study entry and 38.8% reported prior sinus surgery. Over 24 weeks, 76 exacerbations occurred, with 71 resulting in antibiotic use.

The treatment was well tolerated, Mahmoud reported. Adverse events in more than 3% of patients, which were more common with active treatment than placebo, were epistaxis, COVID-19, headache, and nasopharyngitis.

Soler noted that epistaxis events were counted if there was any nasal blood after use of the device.

He also pointed out that patients appeared to handle use of the device well.

Optinose is in the process of filing for FDA approval for the device for this indication, he said. He now uses the device in patients who have nasal polyps, a fraction of the group with chronic rhinosinusitis. "I am excited to be able to use this for a whole other group of patients once it is approved for that use by the FDA," he added.

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