Idiopathic RhinitisNCT06870292
Posterior Nasal Nerve Combined With Anterior Ethmoid Neurotomy for Idiopathic Rhinitis
A study testing Posterior nasal nerve combined with anterior ethmoid neurotomy and Drug therapy group in people with Idiopathic Rhinitis, run by Xu Yu at 2 sites in China.
Trial summary
The present study was a prospective, parallel controlled, multicentre clinical study. The trial was divided into two groups, the posterior nasal nerve combined with anterior ethmoid neurotomy group (group A) and the standardized drug treatment group (group B). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Idiopathic Rhinitis
- What is being tested?
- Posterior nasal nerve combined with anterior ethmoid neurotomy and Drug therapy group
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesChina
- Study dates
- 1 Oct 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients signed the free and informed consent form and understood the explanation of the study.
- patients with IR between 18 and 65 years and their body mass index (BMI) should be ≥19 kg/m2 and ≤24 kg/m2.
- 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.
- Patients with negative skin prick test (SPT) responses or sIgE
- Nasal cytological exam with eosinophilia less than 20%.
- Patients had a Total Nasal Symptom Score (TNSS) of ≥6 and a subscore of nasal discharge ≥2 and a subscore of nasal congestion ≥1.
Who cannot join
- Patients with colored secretions, inflammation，nasal polyps, chronic sinusitis, nasal tumours.
- Patients with other chronic rhinitis such as occupational rhinitis, drug rhinitis, gustatory rhinitis, hormonal rhinitis, atrophic rhinitis, etc.
- Patients with anatomic nasal abnormalities responsible for nasal symptoms.
- Patients with nasal/sinus surgery 3 months before the study.
- Patients with severe mental illness.
- Patients with uncontrolled asthma, systemic disorders or malignancies.
- Patients with history of chronic smoking, substance abuse, drug use, and/or excessive alcohol consumption.
- Patients in pregnancy or lactation.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060
Yu Xu, Doctor of Medicine, +8615927088198, xuy@whu.edu.cn
Hao Lv, Doctor of Medicine, +8618871100056, hao.lv@whu.edu.cn
- Recruiting
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060
About this study
Official title: Assessment of the Effectiveness and Safety of Posterior Nasal Nerve Combined With Anterior Ethmoid Neurotomy in Patients With Idiopathic Rhinitis: a Prospective, Multicentre, Parallel-controlled Study
The present study was a prospective, parallel controlled, multicentre clinical study. The trial was divided into two groups, the posterior nasal nerve combined with anterior ethmoid neurotomy group (group A) and the standardized 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 (Rhinocort®) treatment. Subjects with IR who remained eligible after the introductory period were prospectively assigned to Group A or Group B through a standardized shared decision-making process based on clinical suitability and participant preference. Participants were followed for 1 year after treatment assignment. 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 (Clarityne®) or nasal antihistamines (Azep®) are preferred, and nasal hormones (Rhinocort®), 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 1-year period.
- Conditions
- Idiopathic Rhinitis
- Being tested
- Posterior nasal nerve combined with anterior ethmoid neurotomy, Drug therapy group
- Keywords
- Idiopathic Rhinitis, posterior nasal nerve neurotomy, anterior ethmoid neurotomy, surgical treatment, neuroimmune
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior nasal nerve combined with anterior ethmoid neurotomyProcedure or surgery
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 groupDrug
Subjects will be treated with medication according to guideline recommendations when nasal-related symptoms occur. Clarityne® or Azep® are preferred, and Rhinocort®, or a combination of two or three drugs, may be used in severe cases.
| Study group | Role | What they receive |
|---|---|---|
| Posterior nasal nerve combined with anterior ethmoid neurotomy group | Experimental | Subjects will undergo posterior nasal nerve combined with anterior ethmoid neurotomy under nasal endoscope. Receives: Procedure: Posterior nasal nerve combined with anterior ethmoid neurotomy |
| Drug therapy group | Active comparator | Subjects will be treated with medication according to guideline recommendations when nasal symptoms such as nasal obstruction, rhinorrhea, itching, and sneezing occur. Oral antihistamines (Clarityne®) or nasal antihistamines (Azep®) are preferred, and nasal hormones (Rhinocort®), or a combination of two or three drugs, may be used in severe cases. Receives: Drug: Drug therapy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined symptom and medication score (CSMS)
The combined symptom and medication score (CSMS) is a validated composite metric widely used in clinical research and practice to holistically assess the severity and control of rhinitis. It integrates both subjective symptom burden and objective medication use into a single quantitative score.A questionnaire was used to evaluate the CSMS.
Measured: 3rd postoperative months
Secondary outcomes (5)
Combined symptom and medication score (CSMS)
The combined symptom and medication score (CSMS) is a validated composite metric widely used in clinical research and practice to holistically assess the severity and control of rhinitis. It integrates both subjective symptom burden and objective medication use into a single quantitative score.A questionnaire was used to evaluate the CSMS.
Measured: 6th and 12th postoperative months
Total nasal symptoms score (TNSS)
The total nasal symptoms score (TNSS) is a patient-reported outcome tool widely utilized to quantify the severity of nasal symptoms in allergic rhinitis (AR) and other rhinologic conditions. It provides a standardized, composite assessment of key nasal symptoms including nasal congestion, rhinorrhea, sneezing, and nasal itching. A questionnaire was used to evaluate the TNSS.
Measured: 3rd, 6th, and 12th postoperative months
Rhinoconjunctivitis quality of life questionnaire (RQLQ)
The Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) is a validated, patient-reported outcome measure specifically designed to assess the impact of rhinoconjunctivitis on patients' daily functioning and overall well-being. It incluges 28 items grouped into 7 domains: nasal symptoms, ocular symptoms, practical problems, activity limitations, emotional impact, sleep disturbances, general health perceptions.
Measured: 3rd, 6th, and 12th postoperative months
Rhinitis Control Assessment Test (RCAT)
The RCAT is a patient-reported assessment tool designed to evaluate the level of control over rhinitis symptoms, assisting clinicians in evaluating treatment efficacy and adjusting management strategies.It typically consists of six items assessing the frequency of symptoms (such as nasal congestion, rhinorrhea, and sneezing) and their impact on daily life over the past week. For the RCAT, an internationally recognized questionnaire was used for measurement.
Measured: 3rd, 6th, and 12th postoperative months
Substance P（SP）、Vasoactive Intestinal Peptide（VIP）、Calcitonin Gene-Related Peptide（CGRP）、Neuropeptide Y（NPY）
Neuropeptide substance P (SP), vasoactive intestinal peptide (VIP), calcitonin gene-related peptide (CGRP) and neuropeptide Y (NPY) were measured in nasal secretions using ELISA.
Measured: 3rd, 6th, and 12th postoperative months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start1 Oct 2026 (estimated)
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Idiopathic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xu Yu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xu Yu, Renmin Hospital of Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06870292
- Sponsor's protocol ID
- WDRY2024-K232
- Other IDs
- 2023YFC2507905
- Status last verified
- Sep 2026
- First submitted
- 5 Mar 2025
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36246705Balai 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.
PubMed 36066203Baroody 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.
PubMed 38467330Hellings 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.
PubMed 28474799Lieberman 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.
PubMed 27083104
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effectiveness and Safety of Posterior Nasal Nerve Combined With Anterior Ethmoid Neurotomy in Patients With Idiopathic Rhinitis: a Prospective, Multicentre, Parallel-controlled Study
- ClinicalTrials.gov ID
- NCT06870292
- Acronym / sponsor ID
- WDRY2024-K232
- Conditions
- Idiopathic Rhinitis
- Keywords
- Idiopathic Rhinitis, posterior nasal nerve neurotomy, anterior ethmoid neurotomy, surgical treatment, neuroimmune
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Xu YuUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study was a prospective, parallel controlled, multicentre clinical study. The trial was divided into two groups, the posterior nasal nerve combined with anterior ethmoid neurotomy group (group A) and the standardized 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 (Rhinocort®) treatment. Subjects with IR who remained eligible after the introductory period were prospectively assigned to Group A or Group B through a standardized shared decision-making process based on clinical suitability and participant preference. Participants were followed for 1 year after treatment assignment. 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 (Clarityne®) or nasal antihistamines (Azep®) are preferred, and nasal hormones (Rhinocort®), 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 1-year period.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Posterior nasal nerve combined with anterior ethmoid neurotomy group | Experimental | Procedure: Posterior nasal nerve combined with anterior ethmoid neurotomySubjects will undergo posterior nasal nerve combined with anterior ethmoid neurotomy under nasal endoscope. |
| Drug therapy group | Active comparator | Drug: Drug therapy groupSubjects will be treated with medication according to guideline recommendations when nasal symptoms such as nasal obstruction, rhinorrhea, itching, and sneezing occur. Oral antihistamines (Clarityne®) or nasal antihistamines (Azep®) are preferred, and nasal hormones (Rhinocort®), or a combination of two or three drugs, may be used in severe cases. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients signed the free and informed consent form and understood the explanation of the study.
- patients with IR between 18 and 65 years and their body mass index (BMI) should be ≥19 kg/m2 and ≤24 kg/m2.
- 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.
- Patients with negative skin prick test (SPT) responses or sIgE
- Nasal cytological exam with eosinophilia less than 20%.
Key exclusion criteria (8 listed)
- Patients with colored secretions, inflammation，nasal polyps, chronic sinusitis, nasal tumours.
- Patients with other chronic rhinitis such as occupational rhinitis, drug rhinitis, gustatory rhinitis, hormonal rhinitis, atrophic rhinitis, etc.
- Patients with anatomic nasal abnormalities responsible for nasal symptoms.
- Patients with nasal/sinus surgery 3 months before the study.
- Patients with severe mental illness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Posterior nasal nerve combined with anterior ethmoid neurotomyFirst, 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. | Procedure or surgery | Posterior nasal nerve combined with anterior ethmoid neurotomy group |
| Drug therapy groupSubjects will be treated with medication according to guideline recommendations when nasal-related symptoms occur. Clarityne® or Azep® are preferred, and Rhinocort®, or a combination of two or three drugs, may be used in severe cases. | Drug | Drug therapy group |
Primary outcome
Combined symptom and medication score (CSMS)
Time frame: 3rd postoperative months
The combined symptom and medication score (CSMS) is a validated composite metric widely used in clinical research and practice to holistically assess the severity and control of rhinitis. It integrates both subjective symptom burden and objective medication use into a single quantitative score.A questionnaire was used to evaluate the CSMS.
5 secondary outcomes
Combined symptom and medication score (CSMS)
Time frame: 6th and 12th postoperative months
Total nasal symptoms score (TNSS)
Time frame: 3rd, 6th, and 12th postoperative months
Rhinoconjunctivitis quality of life questionnaire (RQLQ)
Time frame: 3rd, 6th, and 12th postoperative months
Rhinitis Control Assessment Test (RCAT)
Time frame: 3rd, 6th, and 12th postoperative months
Substance P（SP）、Vasoactive Intestinal Peptide（VIP）、Calcitonin Gene-Related Peptide（CGRP）、Neuropeptide Y（NPY）
Time frame: 3rd, 6th, and 12th postoperative months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Background: PubMed 36246705Wu 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.
- Background: PubMed 36066203Balai 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.
- Background: PubMed 38467330Baroody 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.
- Background: PubMed 28474799Hellings 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.
- Background: PubMed 27083104Lieberman 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Posterior nasal nerve combined with anterior ethmoid neurotomy and Drug therapy group in people with Idiopathic Rhinitis, run by Xu Yu at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yu Xu (+8615927088198, xuy@whu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combined symptom and medication score (CSMS) (time frame: 3rd postoperative months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06870292, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.