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

NCT06272032 | Recruiting Early Phase 1

• 1 other identifier: 2023KFKT001
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Rhinitis

Keywords

allergic rhinitis; High-intensity focused ultrasound (HIFU); Clinical efficacy; safety

Outcome Measures

Primary Outcomes (2)

• Nasal Symptom Score

  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)

  1 month, 3 months, 6 months, 1 year, and 2 years post-treatment

• daily medication score

  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)

  1 month, 3 months, 6 months, 1 year, and 2 years post-treatment

Study Arms (2)

High-intensity focused ultrasound (HIFU)

ACTIVE COMPARATOR

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.

Procedure: High-intensity focused ultrasound (HIFU)

Placebo

PLACEBO COMPARATOR

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.

Drug: intranasal corticosteroids, oral antihistamines, oral leukotriene receptor antagonists, and intranasal antihistamines

Interventions

High-intensity focused ultrasound (HIFU) PROCEDURE

Ultrasound is a type of mechanical vibrational wave capable of penetrating 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. It can induce a series of structural and functional changes in tissue cells through actions like cavitation, mechanical force vibration, and heat generation, leading to corresponding clinical effects. Clinical studies have demonstrated 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.

Also known as: Chongqing Haifu Technology Co., Ltd.

High-intensity focused ultrasound (HIFU)

intranasal corticosteroids, oral antihistamines, oral leukotriene receptor antagonists, and intranasal antihistamines DRUG

intranasal corticosteroids, oral antihistamines, oral leukotriene receptor antagonists, and intranasal antihistamines and other therapies.

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients with exacerbation of nasal symptoms, uncontrolled or acute exacerbation of asthma
• Patients with bleeding tendency, coagulation disorders
• Patients with poor overall condition, unable to tolerate procedures
• Patients with severe cardiovascular diseases, immune system disorders, malignant tumors
• 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.
• Patients under 18 years of age or over 70 years of age

Sponsors & Collaborators

• Chongqing Medical University: lead

Study Sites (1)

Chongqing Medical University

Chongqing, Chongqing Municipality, China

RECRUITING

Related Publications (9)

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  PMID: 20816182 BACKGROUND

• Seidman MD, Gurgel RK, Lin SY, Schwartz SR, Baroody FM, Bonner JR, Dawson DE, Dykewicz MS, Hackell JM, Han JK, Ishman SL, Krouse HJ, Malekzadeh S, Mims JW, Omole FS, Reddy WD, Wallace DV, Walsh SA, Warren BE, Wilson MN, Nnacheta LC; Guideline Otolaryngology Development Group. AAO-HNSF. Clinical practice guideline: Allergic rhinitis. Otolaryngol Head Neck Surg. 2015 Feb;152(1 Suppl):S1-43. doi: 10.1177/0194599814561600.

  PMID: 25644617 BACKGROUND

• Bousquet J, Anto JM, Bachert C, Baiardini I, Bosnic-Anticevich S, Walter Canonica G, Melen E, Palomares O, Scadding GK, Togias A, Toppila-Salmi S. Allergic rhinitis. Nat Rev Dis Primers. 2020 Dec 3;6(1):95. doi: 10.1038/s41572-020-00227-0.

  PMID: 33273461 BACKGROUND

• Wang XD, Zheng M, Lou HF, Wang CS, Zhang Y, Bo MY, Ge SQ, Zhang N, Zhang L, Bachert C. An increased prevalence of self-reported allergic rhinitis in major Chinese cities from 2005 to 2011. Allergy. 2016 Aug;71(8):1170-80. doi: 10.1111/all.12874. Epub 2016 Apr 13.

  PMID: 26948849 BACKGROUND

• Bousquet J, Schunemann HJ, Togias A, Bachert C, Erhola M, Hellings PW, Klimek L, Pfaar O, Wallace D, Ansotegui I, Agache I, Bedbrook A, Bergmann KC, Bewick M, Bonniaud P, Bosnic-Anticevich S, Bosse I, Bouchard J, Boulet LP, Brozek J, Brusselle G, Calderon MA, Canonica WG, Caraballo L, Cardona V, Casale T, Cecchi L, Chu DK, Costa EM, Cruz AA, Czarlewski W, D'Amato G, Devillier P, Dykewicz M, Ebisawa M, Fauquert JL, Fokkens WJ, Fonseca JA, Fontaine JF, Gemicioglu B, van Wijk RG, Haahtela T, Halken S, Ierodiakonou D, Iinuma T, Ivancevich JC, Jutel M, Kaidashev I, Khaitov M, Kalayci O, Kleine Tebbe J, Kowalski ML, Kuna P, Kvedariene V, La Grutta S, Larenas-Linnemann D, Lau S, Laune D, Le L, Lieberman P, Lodrup Carlsen KC, Lourenco O, Marien G, Carreiro-Martins P, Melen E, Menditto E, Neffen H, Mercier G, Mosgues R, Mullol J, Muraro A, Namazova L, Novellino E, O'Hehir R, Okamoto Y, Ohta K, Park HS, Panzner P, Passalacqua G, Pham-Thi N, Price D, Roberts G, Roche N, Rolland C, Rosario N, Ryan D, Samolinski B, Sanchez-Borges M, Scadding GK, Shamji MH, Sheikh A, Bom AT, Toppila-Salmi S, Tsiligianni I, Valentin-Rostan M, Valiulis A, Valovirta E, Ventura MT, Walker S, Waserman S, Yorgancioglu A, Zuberbier T; Allergic Rhinitis and Its Impact on Asthma Working Group. Next-generation Allergic Rhinitis and Its Impact on Asthma (ARIA) guidelines for allergic rhinitis based on Grading of Recommendations Assessment, Development and Evaluation (GRADE) and real-world evidence. J Allergy Clin Immunol. 2020 Jan;145(1):70-80.e3. doi: 10.1016/j.jaci.2019.06.049. Epub 2019 Oct 15.

  PMID: 31627910 BACKGROUND

• Jutel M, Agache I, Bonini S, Burks AW, Calderon M, Canonica W, Cox L, Demoly P, Frew AJ, O'Hehir R, Kleine-Tebbe J, Muraro A, Lack G, Larenas D, Levin M, Martin BL, Nelson H, Pawankar R, Pfaar O, van Ree R, Sampson H, Sublett JL, Sugita K, Du Toit G, Werfel T, Gerth van Wijk R, Zhang L, Akdis M, Akdis CA. International Consensus on Allergen Immunotherapy II: Mechanisms, standardization, and pharmacoeconomics. J Allergy Clin Immunol. 2016 Feb;137(2):358-68. doi: 10.1016/j.jaci.2015.12.1300.

  PMID: 26853128 BACKGROUND

• Greiner AN, Hellings PW, Rotiroti G, Scadding GK. Allergic rhinitis. Lancet. 2011 Dec 17;378(9809):2112-22. doi: 10.1016/S0140-6736(11)60130-X. Epub 2011 Jul 23.

  PMID: 21783242 BACKGROUND

• Cheng L, Chen J, Fu Q, He S, Li H, Liu Z, Tan G, Tao Z, Wang D, Wen W, Xu R, Xu Y, Yang Q, Zhang C, Zhang G, Zhang R, Zhang Y, Zhou B, Zhu D, Chen L, Cui X, Deng Y, Guo Z, Huang Z, Huang Z, Li H, Li J, Li W, Li Y, Xi L, Lou H, Lu M, Ouyang Y, Shi W, Tao X, Tian H, Wang C, Wang M, Wang N, Wang X, Xie H, Yu S, Zhao R, Zheng M, Zhou H, Zhu L, Zhang L. Chinese Society of Allergy Guidelines for Diagnosis and Treatment of Allergic Rhinitis. Allergy Asthma Immunol Res. 2018 Jul;10(4):300-353. doi: 10.4168/aair.2018.10.4.300.

  PMID: 29949830 BACKGROUND

• Zhong B, Li LK, Deng D, Du JT, Liu YF, Liu F, Liu SX. Effect of High-Intensity Focused Ultrasound Versus Plasma Radiofrequency Ablation on Recurrent Allergic Rhinitis. Med Sci Monit. 2019 Sep 9;25:6775-6781. doi: 10.12659/MSM.916228.

  PMID: 31496537 BACKGROUND

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Long-Term Synaptic Depression; Histamine Antagonists; Leukotriene Antagonists

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Neuronal Plasticity; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Histamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Shen Yang, Doctoral

  Chongqing Medical University

  STUDY CHAIR

Central Study Contacts

Shen Yang, Doctoral

CONTACT

15111953398; sy_smile@sina.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: January 27, 2024
• First Posted: February 22, 2024
• Study Start: August 1, 2023
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: February 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)