drugset / Trial / NCT06870292

Posterior Nasal Nerve Combined with Anterior Ethmoid Neurotomy for Idiopathic Rhinitis

NCT06870292

Recruiting 150 enrolled Xu Yu
RandomizedParallel-groupOpen-labelTreatment

Summary

The present study was a randomised, parallel controlled, open-label, multicentre clinical study. The trial was divided into two groups, the posterior nasal nerve combined with anterior ethmoid neurotomy group (group A) and the conventional drug treatment group (group B). Patients with idiopathic rhinitis (IR) who met the inclusion criteria were included in a 7-day introductory period of nasal spray hormone (Budesonide nasal spray) treatment. Subjects with IR who met the randomization criteria after the introductory period were randomized 1:1 to either group A or group B for a 1-year treatment follow-up study. In group A, subjects will undergo the posterior nasal nerve combined with anterior ethmoid neurotomy. In group B, subjects will be treated with medication according to guideline recommendations when nasal-related symptoms occur. Oral antihistamines (Loratadine) or nasal antihistamines (Azelastine Hydrochloride) are preferred, and nasal hormones (Budesonide nasal spray), or a combination of two or three drugs, may be used in severe cases. Participants will be evaluated for safety and efficacy throughout the entire three-year period.

Timeline

Start
2025-03-01
Primary completion
2025-12-30
Completion
2026-12-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Azelastine Small molecule Intranasal
Comparator Budesonide Small molecule Intranasal
Comparator Loratadine Small molecule Oral

Indications