Posterior Nasal Nerve Combined with Anterior Ethmoid Neurotomy for Idiopathic Rhinitis

NCT06870292 | Recruiting

• 2 other identifiers: WDRY2024-K2322023YFC2507905
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Idiopathic Rhinitis

Keywords

Idiopathic Rhinitis; posterior nasal nerve neurotomy; anterior ethmoid neurotomy; surgical treatment; neuroimmune

Outcome Measures

Primary Outcomes (1)

• Combined symptom and medication score (CSMS)

  The combined symptom and medication score (CSMS) is a validated composite metric widely used in clinical research and practice to holistically assess the severity and control of rhinitis. It integrates both subjective symptom burden and objective medication use into a single quantitative score.A questionnaire was used to evaluate the CSMS.

  3rd postoperative months

Secondary Outcomes (5)

• Combined symptom and medication score (CSMS)

  6th and 12th postoperative months

• Total nasal symptoms score (TNSS)

  3rd, 6th, and 12th postoperative months

• Rhinoconjunctivitis quality of life questionnaire (RQLQ)

  3rd, 6th, and 12th postoperative months

• Rhinitis Control Assessment Test (RCAT)

  3rd, 6th, and 12th postoperative months

• Substance P（SP）、Vasoactive Intestinal Peptide（VIP）、Calcitonin Gene-Related Peptide（CGRP）、Neuropeptide Y（NPY）

  3rd, 6th, and 12th postoperative months

Study Arms (2)

Posterior nasal nerve combined with anterior ethmoid neurotomy group

EXPERIMENTAL

Subjects will undergo posterior nasal nerve combined with anterior ethmoid neurotomy under nasal endoscope.

Procedure: Posterior nasal nerve combined with anterior ethmoid neurotomy

Drug therapy group

ACTIVE COMPARATOR

Subjects will be treated with medication according to guideline recommendations when nasal symptoms such as nasal obstruction, rhinorrhea, itching, and sneezing occur. Oral antihistamines (Loratadine) or nasal antihistamines (Azelastine) are preferred, and nasal hormones (Budesonide), or a combination of two or three drugs, may be used in severe cases.

Drug: Drug therapy group

Interventions

Posterior nasal nerve combined with anterior ethmoid neurotomy PROCEDURE

First, a vertical incision was made in the posterior portion of the middle nasal turbinate. Dissection was performed along the bone to elevate the mucosal flap to expose the thick orbital process of the vertical plate of the palatine bone and the sphenopalatine foramen. The 3-4 mm of mucosal and submucosal neurovascular bundles surrounding the sphenopalatine foramen were subjected to full radiofrequency ablation, directly to the bone. The mucoperiosteal flap is reposited back. The bilateral nasal cavity was packed with Merocel nasal pack and hemostasis was achieved. The anterior ethmoidal nerves of the lateral nasal branch and septal branch of the nasal cavity were cut off with a plasma treatment needle. Below 30°, the mucous membrane of the posterior lateral wall of the nasal colliculus was cut down to the bone surface using the needle of the nasal endoscope plasma therapy instrument. The contralateral side was then treated in the same way, with an arc cut line and a length of 2cm.

Posterior nasal nerve combined with anterior ethmoid neurotomy group

Drug therapy group DRUG

Subjects will be treated with medication according to guideline recommendations when nasal-related symptoms occur. Oral antihistamines or nasal antihistamines are preferred, and nasal hormones (budesonide nasal spray), or a combination of two or three drugs, may be used in severe cases.

Drug therapy group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Xu Yu: lead

Study Sites (2)

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

NOT YET RECRUITING

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

RECRUITING

Related Publications (5)

• Wu R, Dong L, Mao H, Wang J, Ma D, Sun J. Clinical study on the treatment of moderate to severe persistent allergic rhinitis by posterior nasal nerve combined with anterior ethmoid neurotomy. Pak J Med Sci. 2022 Sep-Oct;38(7):1888-1892. doi: 10.12669/pjms.38.7.5561.

  PMID: 36246705 BACKGROUND

• Balai E, Gupta KK, Jolly K, Darr A. Posterior nasal nerve neurectomy for the treatment of rhinitis: a systematic review and meta-analysis. Eur Ann Allergy Clin Immunol. 2023 May;55(3):101-114. doi: 10.23822/EurAnnACI.1764-1489.268. Epub 2022 Sep 6.

  PMID: 36066203 BACKGROUND

• Baroody FM, Gevaert P, Smith PK, Ziaie N, Bernstein JA. Nonallergic Rhinopathy: A Comprehensive Review of Classification, Diagnosis, and Treatment. J Allergy Clin Immunol Pract. 2024 Jun;12(6):1436-1447. doi: 10.1016/j.jaip.2024.03.009. Epub 2024 Mar 11.

  PMID: 38467330 BACKGROUND

• Hellings PW, Klimek L, Cingi C, Agache I, Akdis C, Bachert C, Bousquet J, Demoly P, Gevaert P, Hox V, Hupin C, Kalogjera L, Manole F, Mosges R, Mullol J, Muluk NB, Muraro A, Papadopoulos N, Pawankar R, Rondon C, Rundenko M, Seys SF, Toskala E, Van Gerven L, Zhang L, Zhang N, Fokkens WJ. Non-allergic rhinitis: Position paper of the European Academy of Allergy and Clinical Immunology. Allergy. 2017 Nov;72(11):1657-1665. doi: 10.1111/all.13200. Epub 2017 Jun 2.

  PMID: 28474799 BACKGROUND

• Lieberman PL, Smith P. Nonallergic Rhinitis: Treatment. Immunol Allergy Clin North Am. 2016 May;36(2):305-19. doi: 10.1016/j.iac.2015.12.007. Epub 2016 Feb 26.

  PMID: 27083104 BACKGROUND

Central Study Contacts

Yu Xu

CONTACT

+8615927088198; xuy@whu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 11, 2025
• Study Start: March 1, 2025
• Primary Completion: December 30, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 11, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)