Posterior Nasal Nerve Combined with Anterior Ethmoid Neurotomy for Idiopathic Rhinitis

Xu Yu

Status: Enrolling

Conditions: Idiopathic Rhinitis

Treatments: Drug: Drug therapy group; Procedure: Posterior nasal nerve combined with anterior ethmoid neurotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT06870292

WDRY2024-K232

2023YFC2507905 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients signed the free and informed consent form and understood the explanation of the study.
2. patients with IR between 18 and 65 years and their body mass index (BMI) should be ≥19 kg/m2 and ≤24 kg/m2.
3. 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.
4. Patients with negative skin prick test (SPT) responses or sIgE
5. Nasal cytological exam with eosinophilia less than 20%.
6. Patients had a Total Nasal Symptom Score (TNSS) of ≥6 and a subscore of nasal discharge ≥2 and a subscore of nasal congestion ≥1.

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Posterior nasal nerve combined with anterior ethmoid neurotomy group

Experimental group

Description:

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

Treatment:

Procedure: Posterior nasal nerve combined with anterior ethmoid neurotomy

Drug therapy group

Active Comparator group

Description:

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.

Treatment:

Drug: Drug therapy group