Fluticasone delivery system reduced exacerbations of chronic rhinosinusitis

Fluticasone delivery system reduced exacerbations of chronic rhinosinusitis

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

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

The 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 given placebo, 41 exacerbations occurred, Mahmoud reported.

“The fluticasone exhalation delivery system is the first and only drug shown in randomized controlled trials to significantly reduce acute exacerbations of chronic rhinosinusitis, offering the potential to improve antibiotic delivery by substantially reducing one of the most common drivers of antibiotic use in outpatients,” he said. he concluded.

He explained that the device has three prongs: one prong goes into each nostril and the third is held in the mouth. Patients exhale through the port in their mouth, which forces fluticasone up the nose more effectively than nasal sprays.

Co-author Zachary Soler, MD, of the Medical University of South Carolina in Charleston, said medpage today that “what’s unique about this study is that it includes patients with chronic sinusitis, which is a disease that really hasn’t had much 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 not only to help patients feel better, but also to see if there was objective relief in the sinuses using imaging. “The answer was that patients feel better and their CT scans look better too.”

“In an acute exacerbation, a patient suddenly feels worse. In my clinic, I saw five patients today who said, ‘Doctor, in the last 10 days I’ve felt significantly worse because of my chronic sinusitis. I’ve had more symptoms, ‘” he said. “So the question was does the use of this drug and device reduce 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 lowest dose of EDS-FLU, the highest dose of EDS-FLU, or placebo. The 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 an escalation of medical care, such as a visit to the doctor or a prescription for antibiotics or steroids. Data from the two trials were combined 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, of which 71 resulted in the use of antibiotics.

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 nasal bleeding after use of the device.

He also noted that patients seemed to handle using the device well.

Optinose is in the process of applying for FDA approval of 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’m excited to be able to use this for another whole group of patients once the FDA approves it for that use,” she added.

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    ed susman is a freelance medical writer based in Fort Pierce, Florida, USA.


Mahmoud is an employee of Optinose, which supported the lawsuit.

Soler revealed relationships with Optinose, Regeneron, and Lyra.

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