Posterior Nasal Nerve Combined with Anterior Ethmoid Neurotomy for Idiopathic Rhinitis

Официальное название

Assessment of the Effectiveness and Safety of Posterior Nasal Nerve Combined with Anterior Ethmoid Neurotomy in Patients with Idiopathic Rhinitis: a Multicentre, Randomised, Parallel-controlled Study

Обзор

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.

Вмешательства

• Процедура Posterior nasal nerve combined with anterior ethmoid neurotomy
  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 nasa
• Препарат Drug therapy group
  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.

Первичные конечные точки

• Combined symptom and medication score (CSMS) [Срок оценки: 3rd postoperative months]

Вторичные конечные точки (5)

• Combined symptom and medication score (CSMS) [Срок оценки: 6th and 12th postoperative months]
• Total nasal symptoms score (TNSS) [Срок оценки: 3rd, 6th, and 12th postoperative months]
• Rhinoconjunctivitis quality of life questionnaire (RQLQ) [Срок оценки: 3rd, 6th, and 12th postoperative months]
• Rhinitis Control Assessment Test (RCAT) [Срок оценки: 3rd, 6th, and 12th postoperative months]
• Substance P（SP）、Vasoactive Intestinal Peptide（VIP）、Calcitonin Gene-Related Peptide（CGRP）、Neuropeptide Y（NPY） [Срок оценки: 3rd, 6th, and 12th postoperative months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• Renmin Hospital of Wuhan University — Ухань
• Renmin Hospital of Wuhan University — Ухань

Публикации

• 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
• 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
• 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
• 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 PMID 28474799
• 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

Идентификаторы

NCT: NCT06870292 · WDRY2024-K232 · 2023YFC2507905

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗