Posterior Nasal Nerve Combined with Anterior Ethmoid Neurotomy for Idiopathic Rhinitis

Last updated: March 5, 2025
Sponsor: Xu Yu
Overall Status: Active - Recruiting

Phase

N/A

Condition

Common Cold

Rhinitis, Allergic, Perennial

Allergy

Treatment

Posterior nasal nerve combined with anterior ethmoid neurotomy

Drug therapy group

Clinical Study ID

NCT06870292
WDRY2024-K232
2023YFC2507905
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients signed the free and informed consent form and understood the explanation ofthe 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 nonsmokingpatients 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 nasaldischarge ≥2 and a subscore of nasal congestion ≥1.

Exclusion

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/orexcessive alcohol consumption.

  8. Patients in pregnancy or lactation.

Study Design

Total Participants: 150
Treatment Group(s): 2
Primary Treatment: Posterior nasal nerve combined with anterior ethmoid neurotomy
Phase:
Study Start date:
March 01, 2025
Estimated Completion Date:
December 30, 2026

Connect with a study center

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei 430060
    China

    Active - Recruiting

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