Results from Sunnyvale, California–based Aerin’s Rhintrac randomized, sham-controlled clinical trial, published in the International Forum of Allergy & Rhinology (IFAR), demonstrated that chronic rhinitis symptoms continued to improve through 12 months after treatment with RhinAer.
Findings build on previous data demonstrating superiority and safety with RhinAer compared to a sham procedure control, including last month’s two-year data that backed the temperature-controlled radiofrequency (RF) technology designed to disrupt nerve signals that cause chronic rhinitis symptoms, including constant runny nose and post-nasal drip.
Rhintrac enrolled 117 patients seeking treatment for chronic rhinitis symptoms of at least six months duration. Patients were randomly assigned to active treatment with RhinAer or to a control arm where patients received a sham procedure replicating RhinAer without delivering RF energy.
At three months, trial arm assignments were revealed and qualified sham patients were given the option to cross over and undergo RhinAer treatment, with the 12-month data reporting follow-up results from 72 patients in the original active treatment arm and six-month follow-up for the 25 patients who elected to cross over.
Aerin said in a news release that the percentage of patient responders in the active treatment arm continued to improve over the 12 months (67.5%, 75.0% and 80.6% at 3, 6, and 12 months, respectively). Responders are defined as patients with a ≥30% improvement in symptoms over baseline prior to the procedure.
The magnitude of symptom reduction also improved, with statistically significant improvements in symptoms of rhinorrhea, nasal congestion, nasal itching and sneezing compared to baseline. Patients also had significant improvements in post-nasal drip and cough symptoms that were sustained through 12 months, while crossover patients experience similar benefits compared to those in the initial active treatment arm.
Aerin added that treatment with RhinAer was well tolerated, with patients reporting low post-procedural pain scores and no post-procedural headaches. No serious device or procedure-related adverse events have been reported in any treatment group to date.
“Publication of these data in such an esteemed journal truly underscores the validity of the trial and its outcomes, and the results are tracking well with our previously published multi-year data on the safety and efficacy of RhinAer,” Aerin founder and CMO Dr. Scott Wolf said in the release. “We are grateful to our physician partners for their tireless efforts in building the clinical body of evidence for RhinAer — evidence that helps otolaryngologists make treatment decisions for their allergic and non-allergic chronic rhinitis patients.”