EDS-FLU is the first non-surgical treatment demonstrated to reduce symptoms of chronic rhinosinusitis (CRS) in randomized clinical trials, regardless of participant's nasal polyp status, according to new research from The Journal of Allergy and Clinical Immunology: In Practice
MILWAUKEE, Jan. 18, 2024 /PRNewswire-PRWeb/ -- An exhalation delivery system with fluticasone (EDS-FLU) may reduce symptoms of chronic rhinosinusitis and improve patient's quality of life according to new research from The Journal of Allergy and Clinical Immunology: In Practice (JACI: In Practice), an official journal of the American Academy of Allergy, Asthma & Immunology (AAAAI).
"Chronic sinusitis affects as much of 10% of the United States population and can make breathing uncomfortable and negatively impact a person's daily life," said lead author James N. Palmer, MD, the David W. Kennedy, MD Endowed Professor of Otorhinolaryngology and Director of Rhinology at the Perelman School of Medicine at the University of Pennsylvania. "These findings provide strong evidence for an effective, non-invasive treatment option for people who continue to experience symptoms of chronic sinusitis after over-the-counter medications have failed. Currently, no FDA approved treatments exist for chronic sinusitis, and we are hoping treatment options will soon be available."
New research finds that an exhalation delivery system with fluticasone (EDS-FLU) is the first non-surgical treatment demonstrated to reduce chronic rhinosinusitis (CRS) symptoms, intrasinus opacification and exacerbations in randomized clinical trials, regardless of participant's nasal polyp status.
Two randomized, placebo-controlled trials in adults with CRS were conducted over a 24-week period. Patients received either EDS-FLU treatments or a placebo twice daily with nasal examinations performed at the initial screening and again at weeks 4, 8, 12 and 24. Patients were then assessed for exacerbations and adverse events in weeks 16, 20 and 24. The results were promising, as - - acute disease exacerbations were reduced by 56-66% with EDS-FLU compared to the placebo. Similarly, patients who used standard-delivery nasal steroid products prior to the study also experienced a significant reduction in their CRS symptoms. Adverse events were minimal and similar to standard-delivery intranasal steroids.
These findings suggest that EDS-FLU is an appropriate first-line treatment for CRS before escalation to surgery or systemic therapy. While CRS without nasal polyps, also called "chronic sinusitis," can be difficult to treat with standard-delivery steroid nasal sprays, this research finds that the "novel biomechanics" of EDS-FLU "creates bi-directional, closed-palate, 'air burst' that... has been shown to produce markedly improved intranasal deposition compared to standard-delivery nasal sprays and delivers drug into superior/posterior regions of the nasal labyrinth." The study suggests that the improved delivery of medication can help reduce symptoms and improve patient's quality of life.
With no current FDA approved treatments for CRS without nasal polyps, this research highlights a useful treatment option for patients and provides valuable insight into potential treatments paths in the future.
The American Academy of Allergy, Asthma & Immunology (AAAAI) is the leading membership organization of more than 7,100 allergists, asthma specialists, clinical immunologists, allied health professionals and other professionals with a special interest in the research and treatment of allergic and immunologic diseases. Established in 1943, the AAAAI has more than 7,100 members in the United States, Canada and 72 other countries and is the go-to resource for patients living with allergies, asthma and immune deficiency disorders.
SOURCE The American Academy of Allergy, Asthma & Immunology