NCT06272032

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

Status unknown EARLY_PHASE1 Last updated 22 February 2024

What this trial tests

EARLY_PHASE1 trial testing High-intensity focused ultrasound (HIFU) in Allergic Rhinitis in 240 participants. Status unknown.

Timeline

1 August 2023

Primary endpoint
31 July 2025

31 July 2025

Quick facts

Lead sponsor	Chongqing Medical University
Phase	EARLY_PHASE1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	240
Start date	1 August 2023
Primary completion	31 July 2025
Estimated completion	31 July 2025
Sites	1 location across China

Drugs / interventions tested

• High-intensity focused ultrasound (HIFU)
• intranasal corticosteroids, oral antihistamines, oral leukotriene receptor antagonists, and intranasal antihistamines

Conditions studied

• Allergic Rhinitis — all drugs for Allergic Rhinitis →

Sponsor

Chongqing Medical University

Who can join

Adults 18 to 70, any sex, with Allergic Rhinitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.