Exhalation delivery system improves chronic rhinosinusitis symptoms

Key takeaways:

• Acute disease exacerbations fell to 66% with treatment — a 56% reduction — compared with placebo.
• Congestion, nasal drainage, facial pain/pressure and hyposmia/anosmia all improved.
• Quality of life also improved.

An exhalation delivery system that uses fluticasone reduced symptoms and improved quality of life for patients with chronic rhinosinusitis, according to a study published in The Journal of Allergy and Clinical Immunology: In Practice.

In fact, this treatment is the first to achieve these outcomes without surgery regardless of nasal polyp status, James N. Palmer, MD, David W. Kennedy MD Endowed Professor of Otorhinolaryngology, Perelman School of Medicine, and colleagues wrote.

Although the treatment already is indicated for chronic rhinosinusitis with nasal polyps, Palmer told Healio, most patients with chronic sinusitis have chronic rhinosinusitis without nasal polyps (CRSsNP).

James N. Palmer

“Our goal was to see if this treatment would work in the CRSsNP patient population. It does, and these data will be central to hopefully getting an FDA indication for CRSsNP,” Palmer said.

Currently, he continued, there are no FDA approved drugs for CRSsNP, which affects at least 10% of the population in the United States.

The ReOpen1 (n = 332) and ReOpen2 (n = 223) studies treated adults with chronic rhinosinusitis (CRS) from 120 sites across 13 countries between November 2018 and November 2021.

ReOpen1 included patients who had CRS with or without nasal polyps, and ReOpen2 only had patients with CRS without nasal polyps.

Patients in the treatment groups received or 186 µg (low dose) or 372 µg (high dose) doses based on one or two sprays per nostril of fluticasone via the EDS-FLU exhalation delivery system (XHANCE; OptiNose) twice a day through 24 weeks.

EDS-FLU is designed to create a bidirectional, closed-palate air burst that delivers the drug to superior and posterior regions of the nasal labyrinth where sinuses drain and ventilate that standard nasal sprays may not reach.

Patients who used EDS-FLU had statistically significant improvements in composite symptom scores (CSS) including congestion, facial pain/pressure and nasal discharge as well as in sinus opacification compared with patients who used a comparator.

The researchers reported 76 acute CRS exacerbations, including 71 treated with antibiotics. Totals included 38 among 27 patients in the placebo group, 19 among 17 patients in the low-dose group and 14 among 13 patients in the high-dose group.

The treatment groups experienced a 56% reduction to 66% in the frequency of acute exacerbations, which the researchers called statistically significant, compared with the placebo group.

“These findings show that this treatment for CRS will also reduce antibiotic usage in patients that often require multiple courses in a year,” Palmer said.

Patients with symptoms who already were using standard-delivery nasal steroids reported more statistically significant symptom improvements with treatment compared with those in the placebo group as well.

The treatment groups also experienced individual improvements in congestion, nasal drainage, facial pain/pressure and hyposmia/anosmia, which the researchers called the cardinal symptoms of CRS, through week 12 compared with comparator use.

As measured by 22-item Sinonasal Outcome Test scores, quality of life (QoL) improved for the treatment groups as well, compared with comparator use.

Patient Global Impression of Change scores also indicated that approximately 80% to 90% of the treatment group and approximately 60% of the placebo group reported disease improvement, which the researchers called a significant difference.

Specifically, approximately 50% to 60% of the treatment group and approximately 25% of the placebo group reported much or very much improvement during the study.

Among patients reporting any perceived degree of disease improvement despite treatment, mean changes in in CT scans of sinuses as scored by sinus opacification were at least –2.86, or at least –7.25 for the patients who reported much or very much improvement.

Among the adverse events that occurred in 3% or more patients, epistaxis, COVID-19, headache and nasopharyngitis occurred more often in the treatment groups than in the placebo group.

The researchers called these findings the first demonstration that medication can objectively and subjectively improve CRS and reduce acute exacerbations, regardless of whether patients have nasal polyps, without escalating treatment to surgery or monoclonal antibodies.

Palmer advised physicians to “institute EDS-FLU in all patients with CRSwNP and consider adding it onto patients with CRSsNP in selected circumstances until FDA has expanded the indication.”

Next, Palmer said, he and his colleagues will study the impact of beginning this treatment regime before surgical intervention to decrease the number of surgeries that these patients need as well as its use after surgery to improve surgical success rates.

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For more information:

James N. Palmer, MD, can be reached at james.palmer@pennmedicine.upenn.edu.