Surgical treatment for idiopathic rhinitis using nerve procedures

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

This study tests if a new type of surgery can help people with idiopathic rhinitis feel better than just using regular medication.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Renmin Hospital of Wuhan University (other)
• Locations: 2 sites (Wuhan, Hubei and 1 other locations)
• Trial ID: NCT06870292 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of a surgical approach combining posterior nasal nerve neurotomy with anterior ethmoid neurotomy for patients suffering from idiopathic rhinitis. Participants are randomized into two groups: one receiving the surgical intervention and the other receiving conventional drug therapy. The study includes a 7-day introductory period with nasal spray treatment before randomization, followed by a one-year follow-up to assess outcomes. The goal is to determine if the surgical method provides better relief from symptoms compared to medication alone.

Who should consider this trial

Good fit: Ideal candidates are nonsmoking adults aged 18 to 65 with a diagnosis of idiopathic rhinitis and specific symptom criteria.

Not a fit: Patients with other forms of chronic rhinitis or nasal conditions such as polyps or chronic sinusitis may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could offer a more effective long-term solution for patients with idiopathic rhinitis who do not respond well to medication.

How similar studies have performed: While similar surgical approaches have been explored, this specific combination of techniques for idiopathic rhinitis is relatively novel and has not been extensively tested.

Eligibility criteria

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.

Where this trial is running

Wuhan, Hubei and 1 other locations

• Renmin Hospital of Wuhan University — Wuhan, Hubei, China (NOT_YET_RECRUITING)
• Renmin Hospital of Wuhan University — Wuhan, Hubei, China (RECRUITING)

Study contacts

• Study coordinator: Yu Xu

Conditions: Idiopathic Rhinitis, posterior nasal nerve neurotomy, anterior ethmoid neurotomy, surgical treatment, neuroimmune