Assessment of the Effectiveness and Safety of Posterior Nasal Nerve Combined With Anterior Ethmoid Neurotomy in Patients With Idiopathic Rhinitis: a Prospective, Multicentre, Parallel-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- Combined symptom and medication score (CSMS)
研究概览
简要总结
The present study was a prospective, parallel controlled, multicentre clinical study. The trial was divided into two groups, the posterior nasal nerve combined with anterior ethmoid neurotomy group (group A) and the standardized 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 (Rhinocort®) treatment. Subjects with IR who remained eligible after the introductory period were prospectively assigned to Group A or Group B through a standardized shared decision-making process based on clinical suitability and participant preference. Participants were followed for 1 year after treatment assignment. 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 (Clarityne®) or nasal antihistamines (Azep®) are preferred, and nasal hormones (Rhinocort®), 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 1-year period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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/m
- •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.
排除标准
- •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.
研究组 & 干预措施
Posterior nasal nerve combined with anterior ethmoid neurotomy group
Subjects will undergo posterior nasal nerve combined with anterior ethmoid neurotomy under nasal endoscope.
干预措施: Posterior nasal nerve combined with anterior ethmoid neurotomy (Procedure)
Drug therapy group
Subjects will be treated with medication according to guideline recommendations when nasal symptoms such as nasal obstruction, rhinorrhea, itching, and sneezing occur. Oral antihistamines (Clarityne®) or nasal antihistamines (Azep®) are preferred, and nasal hormones (Rhinocort®), or a combination of two or three drugs, may be used in severe cases.
干预措施: Drug therapy group (Drug)
结局指标
主要结局
Combined symptom and medication score (CSMS)
时间窗: 3rd postoperative months
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.
次要结局
- 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)
研究者
Xu Yu
Head of Rhinology & Allergy
Renmin Hospital of Wuhan University