Nerve treatment improves chronic rhinitis symptom burden

Key takeaways:

• The RhinAer system generates and applies 4 W of 60°C temperature-controlled bipolar radiofrequency energy to the posterior nasal nerve region to impair the nerve’s ability to promote symptoms of chronic rhinitis.
• Patients experienced a 57.8% improvement in 24-hour reflective total nasal symptom scores compared with baseline after 12 months.
• No serious adverse events related to the device or procedure were reported.

Temperature-controlled radiofrequency neurolysis of the posterior nasal nerve improved the symptom burden of chronic rhinitis compared with a sham procedure, according to a study published in International Forum of Allergy & Rhinology.

The procedure was safe, with results sustained through 12 months, the researchers wrote in the study.

“This study provides results for the ongoing progress of patients enrolled in the RHINTRAC randomized controlled study in which the RhinAer procedure was shown to be superior to sham at 3 months in reducing chronic rhinitis symptoms,” Jose Pablo Stolovitzky, MD, adjunct assistant professor with the department of otolaryngology at Emory School of Medicine, told Healio.

“This study is a prospective randomized control study with a sham control, which is considered the best evidence-based study that one can do,” Masayoshi Takashima, MD, FACS, chair of the department of otolaryngology, head and neck surgery at Houston Methodist Hospital, told Healio.

“We actively compared the results of patients who underwent the study with a control who had the same procedure performed but without actually activating the device,” Takashima said.

Jose Pablo Stolovitzky

The RhinAer System (Aerin Medical Inc.) generates and sends 4 W of 60°C temperature-controlled bipolar radiofrequency energy to a single-use, disposable handheld stylus that is applied to one to five nonoverlapping positions in the posterior nasal nerve (PNN) region for 12 seconds in each position.

By heating up tissue in the back of the nose, the device impairs the PNN’s ability to send signals that promote chronic rhinitis symptoms such as submucosal gland secretion, blood flow in the submucosa and stromal edema, according to the researchers.

Masayoshi Takashima

The system also maintains temperature to avoid injuring nearby tissues. The FDA granted 510(k) clearance for its use in treating chronic rhinitis in 2020, and it has been commercially available since then as well.

The prospective, patient-blinded randomized controlled trial involved 117 patients enrolled at 16 centers in the United States between July and December 2020, randomly assigning 78 to the index active treatment arm and 39 to the index sham control arm. After unblinding at 3 months, 27 of the index sham control patients began active treatment.

The researchers defined responders to treatment as those participants who saw a 30% or greater improvement from baseline in their total 24-hour reflective total nasal symptom scores (rTNSS).

Index active treatment arm findings

Responder rates among participants in the index active treatment arm included 67.5% (95% CI, 55.9%-77.8%) at 3 months, 75% (95% CI, 63.4%-84.5%) at 6 months and 80.6% (95% CI, 69.1%-89.2%) at 12 months, which were superior to responder rates among participants in the index sham control arm.

The participants in the index active treatment arm also experienced significantly greater improvements in their rTNSS scores at 3 months that were sustained through 12 months compared with the index sham control arm.

With a mean baseline rTNSS of 8.3 (95% CI, 7.9-8.7), the index active treatment arm had adjusted mean changes of –3.6 (95% CI, –4.2 to –3) at 3 months, –4.4 (95% CI, –5 to –3.8) at 6 months and –4.8 (95% CI, –5.5 to –4.1) at 12 months (P < .001).

Also, there were significant improvements in rhinorrhea, nasal congestion, nasal itching and sneezing scores in the index active treatment arm sustained through 12 months (P < .001), with improvements in postnasal drip and cough scores as well (P < .001).

However, the researchers did not find any significant differences in the distribution of postnasal drip and cough scores when the index active treatment and index sham control arms were compared at 3 months.

Crossover active treatment arm findings

The patients who began active treatment after 3 months in the index sham control arm, also known as the crossover active treatment arm, had similar mean rTNSS with no significant difference, including 75% (95% CI, 53.3%-90.2%) at 3 months and 64% (95% CI, 42.5%-82%) at 6 months.

The crossover active treatment arm had mean pain VAS scores of 2.4 (95% CI, 1.4-3.3) immediately after the procedure, 0.2 (95% CI, 0-0.3) at 1 month and 0.3 (95% CI, –0.1 to 0.6) at 3 months, which the researchers said was comparable to the index active treatment arm and its mean pain VAS score of 2.1 (95% CI, 1.6-2.6) immediately post-procedure.

Overall improvement

Overall, patients who had the procedure experienced a 57.8% improvement in their chronic rhinitis symptoms after 12 months.

“Our results showed that even up to 12 months, not only was there improvement in symptoms compared to the control arm, but also continued improvement of symptoms at 12 months compared to other timepoints,” Takashima said.

“Overall, the results of this study are very consistent with prior studies and patients in the RHINTRAC study are following a similar course to patients in a recent 24-month long-term follow-up study,” Stolovitzky said.

The researchers further reported that there were no serious events related to the RhinAer System or its procedure, although five patients reported eight adverse events with a possible relationship, including mild purulent nasal drainage, moderate dry eye, mild headache, ear discomfort, mild nasal soreness and nasal bleeding.

According to the researchers, the improvements in rhinorrhea and congestion rTNSS subscores indicate that the procedure interrupts parasympathetic stimulation of the nasal mucosa, just as vidian neurectomy and surgical PNN neurectomy do.

“It’s very interesting that the responder rate increased and chronic rhinitis symptoms, including nasal congestion and rhinorrhea, continued to improve over time, surpassing improvements seen at the initial 3-month evaluation period,” Stolovitzky said.

“This was also seen in the improvement of symptoms of cough and postnasal drip, which are often associated with chronic rhinitis,” he continued.

Blocking parasympathetic innervation can reduce submucosal gland secretion, blood flow in the submucosa and stromal edema as well, the researchers continued, safely and effectively reducing the symptom and treatment burden of chronic rhinitis.

“There are costs and side effects to long-term medication use. For the most part, patients do not like taking medications. In addition, studies have shown decrease in compliance of use of medications with time,” Takashima said.

“As such, having a minimally invasive one-time office procedure to treat patients with persistent postnasal drainage or a ‘runny nose’ has inherent benefits,” he continued. “Considering how many patients suffer from chronic rhinitis, this can be a game changer in regard to how this disease is treated.”

Stolovitzky added that his experience with the system has been excellent.

“My patients tell me that the symptoms that affected their quality of life the most, like nasal congestion and rhinorrhea, were significantly improve after the RhinAer procedure,”he said. Noting the data now available supporting the procedure’s safety, efficacy and durability, Stolovitzky added that the researchers are continuing to follow these patients to see if longer-term benefits persist.

“The RHINTRAC cohort will also be followed through 24 months to confirm the long-term durability of the treatment effect,” Stolovitzky said.

“In addition, we are studying anatomically the various pathways of parasympathetic innervation into the nose to see if we can refine the technique for better outcomes and improving the ease of use,” Takashima said.

“One option for advancing the evidence base for this technology would be to generate real-world evidence that can demonstrate how this procedure might compare to other treatments for chronic rhinitis, including examining the cost-effectiveness of this treatment compared alternative treatments,” Stolovitzky said. “This is especially important considering the fact that the effect of a single RhinAer treatment seems to be quite long-lasting.”

References:

• Aerin Medical announces FDA clearance and US launch of innovative nonsurgical procedure for chronic rhinitis. https://aerinmedical.com/company-news/fda-clearance-nonsurgical-procedure-chronic-rhinitis/. Published March 5, 2020. Accessed Aug. 10, 2022.
• Ehmer D, et al. Allergy Rhinol (Providence). 2022;doi:10.1177/21526575221096045.
• Houston Methodist study finds new chronic rhinitis treatment could be game changer. https://www.houstonmethodist.org/newsroom/houston-methodist-study-finds-new-chronic-rhinitis-treatment-could-be-game-changer/. Published Aug. 8, 2022. Accessed Aug. 10, 2022.

For more information:

Jose Pablo Stolovitzky, MD, can be reached at stol@entofga.com.

Masayoshi Takashima, MD, FACS, can be reached at Houston Methodist Hospital, 6550 Fannin St., Suite 1723, Houston, Texas 77030.