Fluticasone Delivery System Reduced exacerbations of chronic rhinosinusitis

WASHINGTON – Use of a fluticasone expiratory 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, treatment with the EDS-FLU resulted in 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 system’s maker, during a late-breaking presentation at IDWeek.

The reductions were greater with the higher dose (two sprays in each nostril twice a day) than with the lower dose (one spray in each nostril twice a day), he said (P=0.002 and P=0.012).

A total of 20 exacerbations were reported in the low dose group versus 15 in the high dose group. Among the placebo patients, 41 exacerbations occurred, Mahmoud reported.

“The expiratory system with fluticasone is the first and only drug shown in randomized controlled trials to significantly reduce acute exacerbations of chronic rhinosinusitis and offers the potential to improve antibiotic management by addressing one of the most common causes of rhinosinusitis significantly reduced ambulatory use of antibiotics,” 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 breathe out through the port in their mouth, which pushes fluticasone up the top of their nose more effectively than nasal sprays.

Co-author Zachary Soler, MD, of the Medical University of South Carolina at Charleston, narrates MedPage today “What is unique about this study is that it includes patients with chronic sinusitis, a disease for which there are not many studies of specific agents. I don’t have nasal polyps.”

He noted that the aim of the study was not only to help patients feel better, but also to see if there was any objective relief in the sinuses using imaging. “The response was that patients feel better and their CT scans look better too.”

“In an acute exacerbation, a patient suddenly feels worse. In my clinic today I saw five patients who said: ‘Doctor, in the last 10 days I have been feeling significantly worse because of my chronic sinusitis. I have more symptoms,'” he said. “So the question was, does using this drug and this device reduce the frequency of that, and indeed, in the 24-week study, we saw a 60 percent reduction in acute exacerbations.”

In the ReOpen 1 and ReOpen 2 studies, patients with chronic rhinosinusitis were randomized to receive the lower dose of EDS-FLU, the higher dose of EDS-FLU, or placebo. The frequency of an acute exacerbation of chronic rhinosinusitis was defined as a worsening of at least one cardinal symptom of the disease (congestion/congestion, rhinorrhea, facial pressure or pain, or hyposmia/anosmia) for at least 3 days that required escalation of medical care, such as a doctor’s visit or the prescription of antibiotics or steroids. Data from the two studies 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 previous sinus surgery. Within 24 weeks, 76 exacerbations occurred, 71 of which led to the use of antibiotics.

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

Soler noted that epistaxis events were counted when nosebleeds were present after using the device.

He also noted that patients appeared to be doing well using the device.

Optinose is in the process of seeking FDA approval for the device in this indication, he said. He now uses the device on patients with nasal polyps, a fraction of the chronic rhinosinusitis group. “I’m excited to be able to use this for a whole different group of patients once it’s cleared by the FDA for that use,” he added.