Healthcare device maker Aerin Medical has published the positive 12-month results from the RHINTRAC trial of the RhinAer device for the treatment of chronic rhinitis.
RhinAer is a temperature-controlled radiofrequency technology to directly interrupt posterior nasal nerve signals and help reduce chronic rhinitis symptoms.
The results of the RHINTRAC, a randomized, sham-controlled clinical trial, were published in the International Forum of Allergy & Rhinology (IFAR).
These outcomes for the trial’s active treatment group demonstrated that chronic rhinitis symptoms continued to improve after receiving RhinAer therapy for 12 months.
The results add to earlier research showing that RhinAer therapy was both safe and superior to a sham procedure control.
The company recruited 117 participants who were seeking therapy for chronic rhinitis symptoms that had lasted at least six months for the trial.
The patients were either given a sham technique that mimicked the RhinAer therapy without actually delivering RF energy, or they were randomly allocated to undergo an active RhinAer treatment.
After three months, the study arm assignments were made public, and eligible sham patients were offered the choice to switch to RhinAer medication.
In this study, 72 patients in the first active therapy arm’s 12-month follow-up findings and the 25 crossover patients’ six-month follow-up results are presented.
Over 12 months, the proportion of patients who responded to active therapy increased by 67.5%, 75.0% and 80.6% at three, six, and 12 months, respectively.
Patients who show a 30% improvement in symptoms from their pre-procedure baseline are considered responders.
Reflective total nasal symptom score (rTNSS) reductions of 43.3%, 53%, and 57.8% after three, six, and 12 months, respectively, showed that the severity of symptom reduction also improved throughout the trial.
Aerin Medical founder and chief medical officer Scott Wolf said: “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.
“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.”
