As Allergy Season Approaches, What Does the Future of Treatment Look Like for Chronic Rhinosinusitis?

As spring approaches, so too does the inevitable allergy symptom surge that many end up experiencing. As allergy season appears on the horizon, it becomes clear that the impacts of sinus conditions such as chronic rhinosinusitis may only make patients with allergies feel even worse.

As such, those with this condition may require diagnosis and treatment sooner rather than later.

Chronic rhinosinusitis is an inflammatory condition that is seen in the paranasal sinuses, and it is characterized by its persistence for over 12 weeks. The condition is known to impact around 5% of the population in the US.¹

Though the association between allergies and chronic rhinosinusitis remains opaque, variants of the condition can be exacerbated by allergies. As pollen counts rise and seasonal triggers emerge, the proactive management of chronic rhinosinusitis may become necessary, but the question remains regarding the future of treatment.

A combination of medical therapies and, in certain instances, surgical interventions are used to treat chronic rhinosinusitis. Treatment does depend on whether or not the condition involves polyps or not, with the condition being referred to as chronic rhinosinusitis with nasal polyposis (CRSwNP) and without nasal polyposis (CRSsNP).¹

There is medication available for the most commonly-seen form of the sinus condition, which is without nasal polyps. Dupilumab was approved by the US Food and Drug Administration (FDA) in 2019 for adults with nasal polyps accompanied by chronic rhinosinusitis, but those with nasal polyps remain in need of a nonsurgical option.²

If approved by the FDA, a new drug device system could represent the first nonsurgical option for either those with polyps or those without. The novel treatment-device system is known as the 'exhalation delivery system deliver fluticasone' (EDS-FLU) system (Xhance).³

There were some promising findings resulting from the ReOpen1 and ReOpen2 randomized controlled trials on EDS-FLU, with exacerbations, symptoms, and intrasinus opacification seeing improvements. Spearheaded by James N. Palmer, MD, the research underscores the potential of EDS-FLU for this patient population, though no decision has been made yet by the FDA.⁴

The studies involved 120 centers located in 13 countries around the world.³ Palmer recently spoke with the HCPLive editorial team about his team’s research on EDS-FLU and its results, describing the way the device functions for chronic sinusitis patients.⁴

“Because of the way it works, one piece fits in the nose, one piece fits in the mouth, and you blow,” Palmer said. “And with that blowing, first of all, it puts it in at a higher pressure. But more importantly, your soft palate seals. Because your soft palate seals and the nose cone fits really far up into your nose, you're spraying the steroid into a closed cavity. And because it's going into a closed cavity it gets way far back into the sinuses.”⁴

Findings from the ReOpen studies demonstrated notable improvements in symptom scores and intrasinus opacification among subjects treated with EDS-FLU as opposed to those in the placebo arm of the study. Furthermore, EDS-FLU was shown by the investigators to have substantially reduced acute disease exacerbations.³

“The ReOpen program evaluated EDS-FLU efficacy on symptoms, QoL, intrasinus inflammation, and acute exacerbations in patients with CRS, particularly those without nasal polyps,” the investigators wrote. “No medication has previously been shown in replicate, controlled trials to improve symptoms, (quality of life), intrasinus inflammation, and acute exacerbations for this population.”³

Palmer noted in his interview that the only major issue observed with the treatment’s safety profile issue was that a few of the subjects had reported epistaxis, also known as nosebleeds. Palmer said. He added, however, that this is considered fairly standard when using standard-delivery intranasal steroids such as fluticasone.⁴

Clinicians may continue to treat both forms of chronic rhinosinusitis with the means currently available to them. That said, as conditions are exacerbated by allergies this year, many will continue to wait in anticipation of new options for their patients.

References

1. ^{Marcus S, DelGaudio JM, Roland LT, Wise SK. Chronic Rhinosinusitis: Does Allergy Play a Role?. Med Sci (Basel). 2019;7(2):30. Published 2019 Feb 18. doi:10.3390/medsci7020030.}
2. ^{FDA approves first treatment for chronic rhinosinusitis with nasal polyps. FDA News Release. June 26, 2019. https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-chronic-rhinosinusitis-nasal-polyps. Date accessed: February 13, 2024.}
3. ^{T Smith. Disease Improvement Observed in Chronic Rhinosinusitis Patients Using EDS-FLU. HCPLive. https://www.hcplive.com/view/disease-improvement-observed-in-chronic-rhinosinusitis-patients-using-eds-flu. January 22, 2024. Date accessed: February 13, 2024.}
4. ^{T Smith. James Palmer, MD: Reacting to New Findings on EDS-FLU for Chronic Rhinosinusitis. February 8, 2024. https://www.hcplive.com/view/james-palmer-reacting-to-new-findings-on-eds-flu-for-chronic-rhinosinusitis. Date accessed: February 13, 2024.}