Prospective Multicenter Observational Study and Promotion of the Application of Focused Ultrasound in Allergic Rhinitis

Early Phase 1

Recruiting

• Conditions: Allergic Rhinitis
• Interventions: Drug: intranasal corticosteroids, oral antihistamines, oral leukotriene receptor antagonists, and intranasal antihistamines; Procedure: High-intensity focused ultrasound (HIFU)

• Registration Number: NCT06272032
• Lead Sponsor: Chongqing Medical University

Brief Summary

Allergic rhinitis (AR) is a common condition, with nearly 300 million affected individuals in China, significantly impacting the quality of life. Despite standardized drug treatments, approximately 20% of AR patients experience inadequate control and require surgical intervention. AR manifests as nasal itching, sneezing, clear nasal discharge, nasal congestion, primarily associated with inflammation-induced hypertrophy of nasal turbinates and a heightened neurogenic state of the nasal mucosa. Surgical treatment focuses on "reducing hypertrophy" of nasal turbinates and "desensitizing" neurogenic hyperreactivity.High-intensity focused ultrasound (HIFU), as a minimally invasive therapeutic modality in AR, is still in its early stages of application and requires further multicenter clinical studies and widespread adoption. This project collaborates with six established institutions proficient in ultrasound treatment for AR. It aims to conduct a prospective multicenter observational study and subsequent dissemination, emphasizing the application of "reduction of hypertrophy" and "desensitization" in AR.Through standardized case selection, subjective and objective measures such as subjective symptom scores, quality of life assessments, nasal reflex, and nasal resistance tests before and after treatment will be employed to evaluate the effectiveness and safety of HIFU in "reducing hypertrophy" and "desensitizing" aspects of AR. Simultaneously, building on our established Otolaryngology Head and Neck Surgery Alliance and Southwest Allergy Alliance, the research results will be promoted through lectures, hands-on guidance, training sessions, academic conferences, and other means to facilitate the application of HIFU in AR and benefit a larger population of AR patients.

Detailed Description

Ultrasound is a form of mechanical vibrational wave that can penetrate living tissues without causing harm to the tissue. As a non-invasive physical modality, ultrasound boasts advantages such as non-invasive safety, excellent directional propagation, strong penetration capability, and optimal focusing effects. Through actions such as cavitation, mechanical force vibration, and heat generation, ultrasound can induce a series of structural and functional changes in tissue cells, resulting in corresponding clinical effects.As early as 2006, research reported that ultrasound, when focused at specific depths beneath the nasal mucosa, creates scattered, punctate coagulation-type necrosis in the biological focus zone beneath the mucosa. This process involves the dissolution and disappearance of nuclei in some vascular smooth muscle cells, endothelial cell degeneration, partial thrombosis formation, vacuolar degeneration of neural cells, and partial or complete necrosis of glandular cells. The coagulation-type necrosis subsequently dissolves and is absorbed, while the structure of nasal mucosa cup cells, ciliated columnar epithelial cells, and basal cells remains normal, without damage to cilia and microvilli.Clinical studies indicate that focused ultrasound not only improves symptoms of allergic rhinitis (AR) but also holds certain advantages in preserving the structural and functional integrity of the nasal mucosa. However, challenges exist in the current application of focused ultrasound for AR, including weak evidence from clinical studies, insufficient long-term efficacy observations, and limited understanding of treatment complications. Moreover, consensus is lacking on indications, treatment intensity, duration, safety, and complications avoidance, demanding urgent resolution.In light of these challenges and guided by the principle of "minimizing harm to patients in treatment," this study, centered on the minimally invasive surgical treatment of "reduction of hypertrophy" and "desensitization" in AR, aims to collaborate with six established tertiary hospitals in China proficient in ultrasound treatment for AR. The study will conduct a prospective multicenter clinical research to observe the clinical efficacy and safety of ultrasound focus in AR, explore its application value in AR, and promote the safe and effective clinical use of focused ultrasound in AR. The ultimate goal is to enhance the overall therapeutic effectiveness of AR, benefiting a large population of AR patients.

Study Timeline

• Study Start: 2023-08-01
• Study First Submitted: 2024-01-27
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-21
• Last Update Submitted: 2024-02-21
• Study First Posted: 2024-02-22
• Last Update Posted: 2024-02-22
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

1. Refractory AR.
2. Patients exhibiting persistent mucosal hypersensitivity or high secretion state (rhinorrhea, sneezing, etc.).

Exclusion Criteria

1. Patients with exacerbation of nasal symptoms, uncontrolled or acute exacerbation of asthma
2. Patients with bleeding tendency, coagulation disorders
3. Patients with poor overall condition, unable to tolerate procedures
4. Patients with severe cardiovascular diseases, immune system disorders, malignant tumors
5. Patients with psychological disorders or poor compliance, combined with primary immunological diseases (such as Sjögren's syndrome) or abnormal results of tear secretion tests, etc.
6. Patients under 18 years of age or over 70 years of age

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	intranasal corticosteroids, oral antihistamines, oral leukotriene receptor antagonists, and intranasal antihistamines	For patients in the Placebo treatment group, treatment is provided based on the severity of their symptoms, following the protocols outlined in the Allergic Rhinitis (AR) diagnosis and treatment guidelines. Patients are administered intranasal corticosteroids, oral antihistamines, oral leukotriene receptor antagonists, and intranasal antihistamines, as appropriate, in accordance with the severity of their symptoms.
High-intensity focused ultrasound (HIFU)	High-intensity focused ultrasound (HIFU)	The High-Intensity Focused Ultrasound (HIFU) knife, also known as the High-Intensity Focused Ultrasound Tumor Treatment System or HIFU ablation therapy, abbreviated as the HIFU knife, is a non-invasive and non-intrusive tumor treatment method utilizing "high-intensity focused ultrasound technology." This technology was successfully developed by the Ultrasound Medical Engineering Research Institute of Chongqing Medical University in 1997.

Primary Outcome Measures

Name	Time	Method
Nasal Symptom Score	1 month, 3 months, 6 months, 1 year, and 2 years post-treatment	In accordance with the recommendations from the European Academy of Allergy and Clinical Immunology (EAACI), the primary assessment indicators for allergic rhinitis include scoring for four nasal symptoms (itchy nose, sneezing, runny nose, nasal congestion) and two ocular symptoms (itchy/sensation of foreign body/redness of eyes, tearing). Evaluation is conducted using the "four-point scale" and a Visual Analogue Score (VAS) to assess the individual symptoms and/or the overall nasal and ocular symptoms before, during, and after treatment.; 0 points: Asymptomatic; 1. point: Mild symptoms (Signs/symptoms noticeable but barely bothersome; easily tolerated); 2. points: Moderate symptoms (Bothersome symptoms/signs that are clearly noticeable but tolerable); 3. points: Severe symptoms (Intolerable, causing interference with daily activities and/or sleep)
daily medication score	1 month, 3 months, 6 months, 1 year, and 2 years post-treatment	The recorded information includes the medication name, method of use, and dosage. Symptomatic medication scoring is based on the patient's symptomatic medication usage, assessing clinical effectiveness. The scoring method employs a "three-step" approach: one point is assigned for the use of nasal, ocular, oral, or topical antihistamines; two points for nasal corticosteroids (or combined with antihistamines); and three points for oral corticosteroids (or combined with nasal steroids/antihistamines).; 1. point: Oral and/or topical antihistamines (nasal or ocular); 2. points: Nasal corticosteroids (or combination with antihistamines); 3. points: Oral corticosteroids (or combination with nasal corticosteroids/antihistamines)

Trial Locations

Locations (1)

Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China