1b. Laryngoscope, 128:1200-1206, 2018.

Objective To determine the safety and efficacy of temperature-controlled radiofrequency (RF) neurolysis of the posterior nasal nerve (PNN) area for the treatment of chronic rhinitis. Study Design A multicenter, prospective, single-blinded, randomized controlled trial, in which the control arm underwent a sham procedure. Setting Sixteen otolaryngology centers. Methods Patients with 24-hour reflective Total Nasal Symptom Score (rTNSS) ≥6, including moderate to severe rhinorrhea and mild to severe congestion, were randomized 2:1 to active treatment of the posterior nasal nerve area with a temperature-controlled RF device or a sham procedure, with no RF energy delivery. The stylus was applied bilaterally to nonoverlapping areas of the posterior middle meatus and posterior inferior turbinate in each nostril in the region of the PNN. The primary endpoint was responder rate at 3 months, where a response was defined as ≥30% improvement (decrease) in rTNSS from baseline. Results Patients had a mean baseline rTNSS of 8.3 (95% CI, 7.9-8.7) and 8.2 (95% CI, 7.6-8.8) ( P = .797) in the active treatment (n = 77) and sham control (n = 39) arms, respectively. At 3 months, responder rate was significantly higher in the active treatment arm: 67.5% (95% CI, 55.9%-77.8%) vs 41.0% (95% CI, 25.6%-57.9%) ( P = .009). The active treatment arm had a significantly greater decrease in rTNSS (mean, −3.6 [95% CI, −4.2 to −3.0] vs −2.2 [95% CI, −3.2 to −1.3]) ( P = .013). Three adverse events related to the device/procedure were reported, and all resolved. Conclusion This randomized controlled trial showed temperature-controlled neurolysis of the PNN area is free from significant adverse events and superior to a sham procedure in decreasing the symptom burden of chronic rhinitis.

The symptomatic and endoscopic improvements observed confirm the efficacy of the steroid-eluting implant for in-office treatment of CRSwNP after ESS. These longer-term 6-month study results demonstrate that the steroid-eluting implant represents a durable, safe, and effective treatment strategy for this patient population.

BackgroundTopical intranasal corticosteroid sprays (INCSs) are standard treatment for nasal polyps (NPs), but their efficacy is reduced by poor patient compliance and impaired access of drug to the sinus mucosa. A corticosteroid‐eluting sinus implant was designed to address these limitations in patients with recurrent polyposis after sinus surgery by delivering 1350 μg of mometasone furoate (MF) directly to the ethmoid sinus mucosa over approximately 90 days.MethodsA randomized, sham‐controlled, double‐blind trial was undertaken in 300 adults with refractory chronic rhinosinusitis with NPs (CRSwNP), who were candidates for repeat surgery. Eligible patients were randomized (2:1) and underwent in‐office bilateral placement of 2 implants or a sham procedure. All patients used the MF INCS 200 μg once daily. Co‐primary efficacy endpoints were the change from baseline in nasal obstruction/congestion score and bilateral polyp grade, as determined by an independent panel based on centralized, blinded videoendoscopy review.ResultsPatients treated with implants experienced significant reductions in both nasal obstruction/congestion score (p = 0.0074) and bilateral polyp grade (p = 0.0073) compared to controls. At day 90, implants were also associated with significant reductions in 4 of 5 prespecified secondary endpoints compared to control: proportion of patients still indicated for repeat sinus surgery (p = 0.0004), percent ethmoid sinus obstruction (p = 0.0007), nasal obstruction/congestion (p = 0.0248), and decreased sense of smell (p = 0.0470), but not facial pain/pressure (p = 0.9130). One patient experienced an implant‐related serious adverse event (epistaxis).ConclusionSignificant improvements over a range of subjective and objective endpoints, including a reduction in the need for sinus surgery by 61%, suggest that MF sinus implants may play an important role in management of recurrent NP.

ClinicalTrials.gov identifier: NCT02266810.