Tag: sinusitis

‘Exhalation’ System Improves Symptoms for Chronic Sinusitis

Photo by Brittany Colette on Unsplash

An exhalation delivery system that uses a patient’s own breath to carry the anti-inflammatory compound fluticasone (EDS-FLU) directly to the sinuses reduced chronic sinusitis symptoms as well as aggravations and infections associated with chronic sinus inflammation by more than 50%, researchers from the Perelman School of Medicine at the University of Pennsylvania reported.

The two randomised, international clinical trials (NCT03781804 and NCT03960580), published in The Journal of Allergy and Clinical Immunology: In Practice, compared EDS-FLU to a placebo in more than 500 adults with chronic rhinosinusitis with or without nasal polyps. Patients used either EDS-FLU or a placebo twice daily for 24 weeks.

EDS-FLU works through a patient exhaling into the device to send the medication deep into the far reaches of their sinus cavities, where the topical medication is most effective. Sinus symptom scores and CT scan results were significantly improved vs placebo.

Symptoms of nasal congestion, nasal discharge, facial pain/pressure, and loss of smell improved dramatically with EDS-FLU compared to placebo, as measured by the sinonasal outcome test-22, a standardized scoring measure for sinonasal symptoms.

“Chronic sinusitis affects as much of 10 percent 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, 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 experience the symptoms of chronic sinus infections and inflammation, a largely inflammatory condition that causes nasal congestion, sinus pressure, and pain, when the sinus membranes are inflamed for long periods of time.

Although over-the-counter nasal sprays offer marginal relief, no FDA-approved medication exists for the most common form of the condition, chronic rhinosinusitis without nasal polyps, known as “chronic sinusitis.”

While some nasal sprays may offer some symptom relief, patients who were using a standard-delivery nasal spray before study enrollment still reported similar improvements in symptoms compared to others in the study.

These are the first placebo-controlled clinical trials to show that a medication reduces subjective symptoms and objective measures of sinus disease for patients 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 in the case of nasal polyps, lifelong biologic therapies.

EDS-FLU was determined to be as safe as standard over the counter nasal sprays.

Source: University of Pennsylvania School of Medicine

Nasal Swabs, not Snot Colour, are The Best Way to Determine if Kids’ Sinusitis is Bacterial

Photo by Andrea Piacquadio on Unsplash

In children with suspected sinusitis, a nasal swab to test for three types of bacteria can tell whether antibiotics are likely to be effective or not, according to a new JAMA study by researchers at the University of Pittsburgh and UPMC. They also found that nasal discharge colour was no help in differentiating a viral or bacterial infection.

“Sinusitis is one of the most common diseases we see in children, but it’s difficult to diagnose because it’s based on the duration of symptoms: If the child has a runny nose or congestion for more than 10 days, we suspect sinusitis,” said said lead author Nader Shaikh, MD. “For an ear infection, we can look inside the ear; for pneumonia, we listen to the lungs. But for sinusitis, we have nothing to go on from a physical exam. That was very unsatisfying to me.”

With the goal of developing a better tool to diagnose bacterial sinusitis, Shaikh and his team enrolled about 500 children with sinusitis symptoms from six centres across the US and randomly assigned them to receive either a course of antibiotics or placebo. The researchers also took nasal swabs from each child and tested for the three main types of bacteria involved in sinusitis.

Children who tested positive for the bacteria had better resolution of symptoms with antibiotic treatment compared to those who did not have bacteria. These findings suggest that testing for bacteria could be a simple and effective way to detect children who are likely to benefit from antibiotics and avoid prescribing antibiotics to those who wouldn’t.

“If antibiotics aren’t necessary, then why use them?” said Shaikh. “These medications can have side effects, such as diarrhoea, and alter the microbiome, which we still don’t understand the long-term implications of. Overuse of antibiotics can also encourage antibiotic resistance, which is an important public health threat.”

According to Shaikh, a common belief among parents and doctors is that yellow or green snot signals a bacterial infection. Although several small studies have suggested that nasal discharge colour is not meaningful, Shaikh and his team formally tested this idea by asking parents to identify the hue of their child’s snot on a colour card.

“If kids with green or yellow discharge benefitted more from antibiotics than those with clear-coloured discharge, we would know that colour is relevant for bacterial infection,” explained Shaikh. “But we found no difference, which means that colour should not be used to guide medical decisions.”

The researchers are now looking at how to best roll out nasal testing in the clinic. A major challenge is that bacterial culture-based tests used in the study are not easy for most family doctors to order and can take several days to get results. A more practical approach could be commercially available molecular testing, which could return results overnight, said Shaikh.

Another possibility could be development of rapid antigen tests that work like COVID-19 at-home testing kits. The researchers also plan to delve deeper into the data from this study to see whether there could be another type of biomarker in nasal discharge indicating the presence of bacteria that would be easier to test for.

Source: University of Pittsburgh