NCT06870292 Posterior Nasal Nerve Combined with Anterior Ethmoid Neurotomy for Idiopathic Rhinitis
| NCT ID | NCT06870292 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Xu Yu |
| Condition | Idiopathic Rhinitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-03-01 |
| Primary Completion | 2025-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2025-03-01 with a primary completion date of 2025-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06870292 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Idiopathic Rhinitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06870292 currently recruiting?
Yes, NCT06870292 is actively recruiting participants. Contact the research team at xuy@whu.edu.cn for enrollment information.
Where is the NCT06870292 trial being conducted?
This trial is being conducted at Wuhan, China, Wuhan, China.
Who is sponsoring the NCT06870292 clinical trial?
NCT06870292 is sponsored by Xu Yu. The trial plans to enroll 150 participants.