A Breakthrough Treatment for Chronic Sinusitis

Chronic sinusitis, or chronic rhinosinusitis (CRS), is a prevalent inflammatory condition that impacts around 31 million American adults. For many patients, symptoms like nasal congestion, drainage, facial pressure and reduced sense of smell persist despite initial treatments with over-the-counter medications. While prescription nasal sprays can help in some cases, no Food and Drug Administration (FDA)-approved medications existed specifically for CRS without nasal polyps – the most common form affecting over two-thirds of patients.

This leaves many people struggling with poor quality of life due to ongoing symptoms. Frequently taking antibiotics to try and curb flare-ups may not fully address the underlying chronic inflammation and contributes to antibiotic resistance concerns. For those with severe or treatment-resistant CRS, sinus surgery was often the next escalation.

Two new large clinical trials provide the first replicate evidence that a medication can effectively improve both subjective and objective measures of disease for all CRS patients – whether or not polyps are present. The treatment, an exhalation delivery system with fluticasone (EDS-FLU, brand name Xhance), has broken new ground by demonstrating clear benefits across symptoms, quality of life, sinus inflammation and acute exacerbations.

The REOPEN Studies

The REOPEN studies included over 500 patients across two randomized, double-blind trials conducted internationally. In REOPEN1, patients with CRS both with and without polyps were randomized to twice-daily EDS-FLU at two different doses or an identical appearing EDS placebo. REOPEN2 focused specifically on people with CRS without polyps.

The primary endpoints were change in composite sinus symptom scores after 4 weeks of treatment and change in sinus inflammation as measured by computerized tomography (CT) scans of the sinuses after 24 weeks. Secondary outcomes evaluated individual symptoms, quality of life impacts, patient perceptions of change and frequency of acute exacerbations requiring escalation of care like antibiotics.

Clinically Significant Results Across the Board

In both trials, EDS-FLU produced statistically superior results to the EDS placebo control on every measure. For example:

– Symptom scores improved 1.5-1.6 points more with EDS-FLU versus 0.6 points with placebo after 4 weeks.

– Sinus opacity on CT scans, reflecting inflammation, decreased 5.6-6.2% more with EDS-FLU versus 1.6% with placebo from baseline to 24 weeks.

– Quality of life as assessed by the validated SNOT-22 scores improved nearly 13 points more.

– Patient-reported impressions of disease change and classification as “improved” favored EDS-FLU over placebo by about 2-3 times.

Notably, acute exacerbations requiring escalated care like antibiotics were reduced by 56-66% when using EDS-FLU compared to placebo across both trials. All improvements were statistically significant based on predetermined analyses.

Mechanism of More Effective Delivery

The improvement stems from the novel delivery mechanism of the EDS device. It coordinates drug release into exhaled airflow from the mouth to create a coordinated bi-directional “air burst” through both nostrils. This deposition pattern from the device reaches well beyond where standard nasal sprays distribute medication, delivering drug up high into sinus drainage pathways and the middle meatus normally bypassing standard sprays.

Importantly, the studies also found patients entering with persistent symptoms despite already using prescription nasal steroid sprays still responded significantly to switching to EDS-FLU. This suggests its delivery translates to clinical benefit even when alternative therapies have fallen short. Adverse effects with EDS-FLU were comparable to nasal sprays.

Breakthrough Evidence for CRS Treatment

Collectively, this is the first well-controlled evidence demonstrating that any medical treatment reduces symptoms, improves quality of life and objective sinus measures like inflammation simultaneously in CRS patients. With replication across the two major studies, EDS-FLU has achieved a new standard of care by offering the first FDA-approved option specifically for CRS without polyps.

For patients and providers facing the challenges of uncontrolled or treatment-resistant CRS, EDS-FLU provides an important new nonsurgical management strategy. By targeting sinus inflammation more precisely, it could help curb inappropriate antibiotic use and maximize medical therapy prior to considering sinus surgery. Further research will continue to optimize care for the millions suffering from this debilitating condition.

Reference(s)

1. DOI: 10.1016/j.jaip.2023.12.016

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