An exhalation delivery system that uses a patient’s own breath to deliver the anti-inflammatory compound fluticasone (EDS-FLU) directly to the sinuses reduces chronic sinus infection (sinusitis) symptoms as well as aggravations and infections associated with chronic sinus inflammation by more than half, according to researchers at the University of Pennsylvania’s Perelman School of Medicine.
The randomized, multinational clinical trials (NCT03781804, NCT03960580), published today in The Journal of Allergy and Clinical Immunology: EDS-FLU was compared to a placebo in over 500 persons with chronic rhinosinusitis, with or without nasal polyps.
Patients took either EDS-FLU or a placebo twice a day for 24 weeks. EDS-FLU works by having the patient exhale into the device, which sends the medication deep into the sinus cavities, where the topical medication is most effective. When compared to a placebo, sinus symptom scores and CT scan results improved dramatically.
The sinonasal outcome test-22, a standardized scoring scale for sinonasal symptoms, revealed that EDS-FLU significantly improved symptoms of nasal congestion, nasal discharge, facial pain/pressure, and loss of smell when compared to placebo.
“Chronic sinusitis affects as much as 10 percent of the United States population and can make breathing uncomfortable and negatively impact a person’s daily life”, According to primary author James N. Palmer, MD, the David W. Kennedy, MD Endowed Professor of Otorhinolaryngology and director of Rhinology at Penn Medicine. “These findings provide strong evidence for an effective, non-invasive treatment option for people who continue to experience symptoms after over-the-counter medications have failed.”
Millions of Americans suffer from chronic sinus infections and inflammation, which is primarily an inflammatory disorder characterized by nasal congestion, sinus pressure, and pain when the sinus membranes become inflamed for extended periods of time. Although over-the-counter nasal sprays provide some comfort, no FDA-approved treatment exists for the most prevalent kind of the ailment, chronic rhinosinusitis without nasal polyps, sometimes known as “chronic sinusitis.”
While some nasal sprays may provide some symptom alleviation, patients who used a standard-delivery nasal spray prior to study enrollment reported similar improvements in symptoms to those in the trial. These are the first placebo-controlled clinical trials to demonstrate that medicine improves subjective symptoms and objective measurements of sinus illness in people with chronic sinusitis, both with and without polyps.
Currently, patients whose symptoms are not resolved by over-the-counter nasal sprays or other medications have limited options for relief, including antibiotics, surgery, or—for patients with nasal polyps—lifelong biologic therapies.
EDS-FLU was determined to be as safe as standard over-the-counter nasal sprays.
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