Allergic RhinitisEarly Phase 1NCT06272032
Prospective Multicenter Observational Study and Promotion of the Application of Focused Ultrasound in Allergic Rhinitis
A Early Phase 1 study testing High-intensity focused ultrasound (HIFU) and intranasal corticosteroids, oral antihistamines, oral leukotriene receptor antagonists, and intranasal antihistamines in people with Allergic Rhinitis, run by Chongqing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- High-intensity focused ultrasound (HIFU) and intranasal corticosteroids, oral antihistamines, oral leukotriene receptor antagonists, and intranasal antihistamines
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2023to 31 Jul 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Refractory AR.
- Patients exhibiting persistent mucosal hypersensitivity or high secretion state (rhinorrhea, sneezing, etc.).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chongqing Medical University
Chongqing, Chongqing Municipality
Shen Yang, Doctoral, 15111953398, sy_smile@sina.cn
About this study
Official title: Prospective Multicenter Observational Study and Promotion of the Application of Focused Ultrasound in "Reduction of Hypertrophy" and "Desensitization" for Allergic Rhinitis
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.
Read the 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.
- Conditions
- Allergic Rhinitis
- Being tested
- High-intensity focused ultrasound (HIFU), intranasal corticosteroids, oral antihistamines, oral leukotriene receptor antagonists, and intranasal antihistamines
- Keywords
- allergic rhinitis, High-intensity focused ultrasound (HIFU), Clinical efficacy, safety
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity focused ultrasound (HIFU)Procedure or surgery
Also called Chongqing Haifu Technology Co., Ltd.
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.
intranasal corticosteroids, oral antihistamines, oral leukotriene receptor antagonists, and intranasal antihistaminesDrug
intranasal corticosteroids, oral antihistamines, oral leukotriene receptor antagonists, and intranasal antihistamines and other therapies.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: intranasal corticosteroids, oral antihistamines, oral leukotriene receptor antagonists, and intranasal antihistamines |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
- point: Mild symptoms (Signs/symptoms noticeable but barely bothersome; easily tolerated)
- points: Moderate symptoms (Bothersome symptoms/signs that are clearly noticeable but tolerable)
- points: Severe symptoms (Intolerable, causing interference with daily activities and/or sleep)
Measured: 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).
- point: Oral and/or topical antihistamines (nasal or ocular)
- points: Nasal corticosteroids (or combination with antihistamines)
- points: Oral corticosteroids (or combination with nasal corticosteroids/antihistamines)
Measured: 1 month, 3 months, 6 months, 1 year, and 2 years post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start1 Aug 2023
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Allergic 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Yucheng, Chongqing Medical University
- Investigators
- Shen Yang, Doctoral, Study chair, Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06272032
- Sponsor's protocol ID
- 2023KFKT001
- Status last verified
- Feb 2024
- First submitted
- 27 Jan 2024
- Last updated
- 22 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD sharing plan for this research project is designed to promote transparency, collaboration, and further scientific inquiry. In accordance with open science principles, we are committed to sharing anonymized individual participant data with other researchers who seek to validate findings, conduct meta-analyses, or explore related research questions.
Publications
Brozek JL, Bousquet J, Baena-Cagnani CE, Bonini S, Canonica GW, Casale TB, van Wijk RG, Ohta K, Zuberbier T, Schunemann HJ; Global Allergy and Asthma European Network; Grading of Recommendations Assessment, Development and Evaluation Working Group. Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines: 2010 revision. J Allergy Clin Immunol. 2010 Sep;126(3):466-76. doi: 10.1016/j.jaci.2010.06.047.
PubMed 20816182Seidman 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.
PubMed 25644617Bousquet 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.
PubMed 33273461Wang 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.
PubMed 26948849Bousquet 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.
PubMed 31627910Jutel 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.
PubMed 26853128Greiner 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.
PubMed 21783242Cheng 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.
PubMed 29949830Zhong 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.
PubMed 31496537
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Observational Study and Promotion of the Application of Focused Ultrasound in "Reduction of Hypertrophy" and "Desensitization" for Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT06272032
- Acronym / sponsor ID
- 2023KFKT001
- Conditions
- Allergic Rhinitis
- Keywords
- allergic rhinitis, High-intensity focused ultrasound (HIFU), Clinical efficacy, safety
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 22 Feb 2024 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-intensity focused ultrasound (HIFU) | Active comparator | Procedure: 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. |
| Placebo | Placebo comparator | Drug: intranasal corticosteroids, oral antihistamines, oral leukotriene receptor antagonists, and intranasal antihistaminesFor 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Refractory AR.
- Patients exhibiting persistent mucosal hypersensitivity or high secretion state (rhinorrhea, sneezing, etc.).
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| High-intensity focused ultrasound (HIFU)Also: Chongqing Haifu Technology Co., Ltd.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. | Procedure or surgery | High-intensity focused ultrasound (HIFU) |
| intranasal corticosteroids, oral antihistamines, oral leukotriene receptor antagonists, and intranasal antihistaminesintranasal corticosteroids, oral antihistamines, oral leukotriene receptor antagonists, and intranasal antihistamines and other therapies. | Drug | Placebo |
Primary outcome
Nasal Symptom Score
Time frame: 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
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Background: PubMed 20816182Brozek JL, Bousquet J, Baena-Cagnani CE, Bonini S, Canonica GW, Casale TB, van Wijk RG, Ohta K, Zuberbier T, Schunemann HJ; Global Allergy and Asthma European Network; Grading of Recommendations Assessment, Development and Evaluation Working Group. Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines: 2010 revision. J Allergy Clin Immunol. 2010 Sep;126(3):466-76. doi: 10.1016/j.jaci.2010.06.047.
- Background: PubMed 25644617Seidman 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.
- Background: PubMed 33273461Bousquet 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.
- Background: PubMed 26948849Wang 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.
- Background: PubMed 31627910Bousquet 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.
- Background: PubMed 26853128Jutel 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.
- Background: PubMed 21783242Greiner 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.
- Background: PubMed 29949830Cheng 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.
- Background: PubMed 31496537Zhong 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.
- Individual participant dataSharing planned: No. The IPD sharing plan for this research project is designed to promote transparency, collaboration, and further scientific inquiry. In accordance with open science principles, we are committed to sharing anonymized individual participant data with other researchers who seek to validate findings, conduct meta-analyses, or explore related research questions.
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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. This study is not recruiting at the moment.
Shen Yang, Doctoral study chair
Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing High-intensity focused ultrasound (HIFU) and intranasal corticosteroids, oral antihistamines, oral leukotriene receptor antagonists, and intranasal antihistamines in people with Allergic Rhinitis, run by Chongqing Medical University at 1 site 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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shen Yang, Doctoral (15111953398, sy_smile@sina.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nasal Symptom Score (time frame: 1 month, 3 months, 6 months, 1 year, and 2 years post-treatment). The study lists 2 primary outcomes in all. 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 NCT06272032, which also lists 9 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 22 Feb 2024.