Posterior Nasal Nerve Combined with Anterior Ethmoid Neurotomy for Idiopathic Rhinitis

Recruiting now · Not applicable

Conditions studied: Idiopathic Rhinitis

In brief

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.

Key facts

Study ID

NCT06870292

Run by

Xu Yu

People needed

150

Starts

2025-03-01

Expected to finish

2026-12-30

Last updated by the study team

2025-03-11

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients signed the free and informed consent form and understood the explanation of the study.
• patients with IR between 18 and 65 years and their body mass index (BMI) should be ≥19 kg/m2 and ≤24 kg/m2.
• Patients diagnosed with idiopathic rhinitis （IR）that were defined as nonsmoking patients with at least 2 nasal complaints of nasal obstruction, rhinorrhea, itching, and/or sneezing for more than 1 hour a day and for more than 1 year.
• Patients with negative skin prick test (SPT) responses or sIgE
• Nasal cytological exam with eosinophilia less than 20%.
• Patients had a Total Nasal Symptom Score (TNSS) of ≥6 and a subscore of nasal discharge ≥2 and a subscore of nasal congestion ≥1.

You may not qualify if…

• Patients with colored secretions, inflammation，nasal polyps, chronic sinusitis, nasal tumours.
• Patients with other chronic rhinitis such as occupational rhinitis, drug rhinitis, gustatory rhinitis, hormonal rhinitis, atrophic rhinitis, etc.
• Patients with anatomic nasal abnormalities responsible for nasal symptoms.
• Patients with nasal/sinus surgery 3 months before the study.
• Patients with severe mental illness.
• Patients with uncontrolled asthma, systemic disorders or malignancies.
• Patients with history of chronic smoking, substance abuse, drug use, and/or excessive alcohol consumption.
• Patients in pregnancy or lactation.

Where it is running

• Renmin Hospital of Wuhan University — Wuhan, Hubei, China (enrolling)
• Renmin Hospital of Wuhan University — Wuhan, Hubei, China

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.