Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT06870292

Posterior Nasal Nerve Combined with Anterior Ethmoid Neurotomy for Idiopathic Rhinitis

Led by Xu Yu · Updated on 2025-03-11

150

Participants Needed

2

Research Sites

95 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Posterior Nasal Nerve Combined with Anterior Ethmoid Neurotomy for Idiopathic Rhinitis

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent and understood study explanation
  • Age between 18 and 65 years with BMI between 19 and 24 kg/m2
  • Diagnosed with idiopathic rhinitis with at least 2 nasal symptoms (obstruction, rhinorrhea, itching, sneezing) lasting over 1 year
  • Negative skin prick test or specific IgE
  • Nasal cytology showing eosinophils less than 20%
  • Total Nasal Symptom Score (TNSS) of 6 or greater with nasal discharge subscore at least 2 and nasal congestion subscore at least 1
Not Eligible

You will not qualify if you...

  • Presence of colored nasal secretions, inflammation, nasal polyps, chronic sinusitis, or nasal tumors
  • Other chronic rhinitis types such as occupational, drug-induced, gustatory, hormonal, or atrophic rhinitis
  • Anatomical nasal abnormalities causing symptoms
  • Nasal or sinus surgery within 3 months prior to enrollment
  • Severe mental illness
  • Uncontrolled asthma, systemic diseases, or cancer
  • History of chronic smoking, substance abuse, drug use, or excessive alcohol consumption
  • Pregnancy or breastfeeding

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Renmin Hospital of Wuhan University

Wuhan, Hubei, China, 430060

Not Yet Recruiting

2

Renmin Hospital of Wuhan University

Wuhan, Hubei, China, 430060

Actively Recruiting

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Research Team

Y

Yu Xu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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