Posterior Nasal Nerve Combined with Anterior Ethmoid Neurotomy for Idiopathic Rhinitis
NCT ID: NCT06870292
Last Updated: 2025-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
150 participants
INTERVENTIONAL
2025-03-01
2026-12-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Laser Posterior Nasal Nerve Neurolysis
NCT07050992
Posterior Nasal Nerve Neurectomy for Treatment of Intractable Allergic Rhinitis
NCT06887842
Diagnostic Efficacy of CDA Nasal Provocation Test in Patients With IR
NCT06682676
Oxymetazoline Hydrochloride in Combination With Nasal Glucocorticosteroid for Perennial Allergic and Non-allergic Rhinitis in Subjects With Persistent Nasal Congestion
NCT00584662
Efficacy of Macrolide and Glucocorticoid in the Treatment of Chronic Rhinosinusitis After Endoscopic Sinus Surgery
NCT02182492
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Posterior nasal nerve combined with anterior ethmoid neurotomy group
Subjects will undergo posterior nasal nerve combined with anterior ethmoid neurotomy under nasal endoscope.
Posterior nasal nerve combined with anterior ethmoid neurotomy
First, a vertical incision was made in the posterior portion of the middle nasal turbinate. Dissection was performed along the bone to elevate the mucosal flap to expose the thick orbital process of the vertical plate of the palatine bone and the sphenopalatine foramen. The 3-4 mm of mucosal and submucosal neurovascular bundles surrounding the sphenopalatine foramen were subjected to full radiofrequency ablation, directly to the bone. The mucoperiosteal flap is reposited back. The bilateral nasal cavity was packed with Merocel nasal pack and hemostasis was achieved.
The anterior ethmoidal nerves of the lateral nasal branch and septal branch of the nasal cavity were cut off with a plasma treatment needle. Below 30°, the mucous membrane of the posterior lateral wall of the nasal colliculus was cut down to the bone surface using the needle of the nasal endoscope plasma therapy instrument. The contralateral side was then treated in the same way, with an arc cut line and a length of 2cm.
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 (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.
Drug therapy group
Subjects will be treated with medication according to guideline recommendations when nasal-related symptoms occur. Oral antihistamines or nasal antihistamines are preferred, and nasal hormones (budesonide nasal spray), or a combination of two or three drugs, may be used in severe cases.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Posterior nasal nerve combined with anterior ethmoid neurotomy
First, a vertical incision was made in the posterior portion of the middle nasal turbinate. Dissection was performed along the bone to elevate the mucosal flap to expose the thick orbital process of the vertical plate of the palatine bone and the sphenopalatine foramen. The 3-4 mm of mucosal and submucosal neurovascular bundles surrounding the sphenopalatine foramen were subjected to full radiofrequency ablation, directly to the bone. The mucoperiosteal flap is reposited back. The bilateral nasal cavity was packed with Merocel nasal pack and hemostasis was achieved.
The anterior ethmoidal nerves of the lateral nasal branch and septal branch of the nasal cavity were cut off with a plasma treatment needle. Below 30°, the mucous membrane of the posterior lateral wall of the nasal colliculus was cut down to the bone surface using the needle of the nasal endoscope plasma therapy instrument. The contralateral side was then treated in the same way, with an arc cut line and a length of 2cm.
Drug therapy group
Subjects will be treated with medication according to guideline recommendations when nasal-related symptoms occur. Oral antihistamines or nasal antihistamines are preferred, and nasal hormones (budesonide nasal spray), or a combination of two or three drugs, may be used in severe cases.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Xu Yu
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Xu Yu
Dr.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Yu Xu, Doctor of Medicine
Role: backup
References
Explore related publications, articles, or registry entries linked to this study.
Wu R, Dong L, Mao H, Wang J, Ma D, Sun J. Clinical study on the treatment of moderate to severe persistent allergic rhinitis by posterior nasal nerve combined with anterior ethmoid neurotomy. Pak J Med Sci. 2022 Sep-Oct;38(7):1888-1892. doi: 10.12669/pjms.38.7.5561.
Balai E, Gupta KK, Jolly K, Darr A. Posterior nasal nerve neurectomy for the treatment of rhinitis: a systematic review and meta-analysis. Eur Ann Allergy Clin Immunol. 2023 May;55(3):101-114. doi: 10.23822/EurAnnACI.1764-1489.268. Epub 2022 Sep 6.
Baroody FM, Gevaert P, Smith PK, Ziaie N, Bernstein JA. Nonallergic Rhinopathy: A Comprehensive Review of Classification, Diagnosis, and Treatment. J Allergy Clin Immunol Pract. 2024 Jun;12(6):1436-1447. doi: 10.1016/j.jaip.2024.03.009. Epub 2024 Mar 11.
Hellings PW, Klimek L, Cingi C, Agache I, Akdis C, Bachert C, Bousquet J, Demoly P, Gevaert P, Hox V, Hupin C, Kalogjera L, Manole F, Mosges R, Mullol J, Muluk NB, Muraro A, Papadopoulos N, Pawankar R, Rondon C, Rundenko M, Seys SF, Toskala E, Van Gerven L, Zhang L, Zhang N, Fokkens WJ. Non-allergic rhinitis: Position paper of the European Academy of Allergy and Clinical Immunology. Allergy. 2017 Nov;72(11):1657-1665. doi: 10.1111/all.13200. Epub 2017 Jun 2.
Lieberman PL, Smith P. Nonallergic Rhinitis: Treatment. Immunol Allergy Clin North Am. 2016 May;36(2):305-19. doi: 10.1016/j.iac.2015.12.007. Epub 2016 Feb 26.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023YFC2507905
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
WDRY2024-K232
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.