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临床试验/NCT06891274
NCT06891274尚未招募不适用

Study on the Lung Aerosol Deposition of Ultrasonic Rock Salt Inhalation Therapy

Jingen Xia1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2025年3月31日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
26
试验地点
1
主要终点
In Vitro Model Pulmonary Deposition Rate

研究概览

简要总结

In the in vitro modeling phase, the investigators plan to use a realistic human upper respiratory tract model and an asymmetric ideal bronchial tree model. By combining 3D printing experiments with CFD simulations, the investigators will investigate the respiratory tract deposition rate and distribution of micro - moist particles in ultrasound rock salt aerosol inhalation therapy. This will be compared with a small - volume nebulizer to verify the effectiveness of ultrasound rock salt aerosol inhalation therapy and lay the foundation for further research on the application of this inhalation technique to other drug formulations.

In the clinical phase, the investigators plan to have subjects inhale radioactive aerosols and use PET/CT imaging technology to assess the deposition rate of aerosol particles in the lungs. By quantitatively analyzing the images, the investigators will study their distribution characteristics in real human bodies to verify the accuracy of the in vitro models and the potential for clinical application.

详细描述

I. Research Background Respiratory diseases, such as asthma, COPD, cystic fibrosis and other chronic respiratory inflammatory diseases, are major global health problems. WHO data shows respiratory diseases are the world's second - leading cause of death, with rising incidence. These diseases, marked by chronic inflammation, airway obstruction and increased airway reactivity, severely affect patients' quality of life. Traditional treatments include inhaled corticosteroids, long - acting bronchodilators and systemic medications. While effective in symptom control and disease progression, they have limitations like systemic side - effects and low drug deposition efficiency from inhalers.

Ultrasonic rock salt aerosol inhalation therapy uses ultrasonic atomization to convert salt solution into tiny aerosol particles, with advantages like high efficiency, micro - moisture, dry aerosol properties, and physiological effects such as enhanced clearance and anti - inflammation.

It has been preliminarily applied in respiratory disease treatment, showing potential in reducing acute exacerbations and improving patients' quality of life. With technological advances and better understanding of aerosol delivery, this therapy has a promising future in respiratory disease management. Future research should focus on confirming its long - term efficacy and safety, exploring personalized applications and evaluating its role in comprehensive treatment strategies.

II. Research Objectives To clarify the process and state of ultrasonic micro - moist rock salt aerosol entering the airway, verify the advantages of the new inhalation device's effective inhalation deposition rate, and provide a new, convenient and effective inhalation technology for drug delivery.

III. Research Overview 3.1 Overall Research Design and Plan This prospective, randomized, crossover study includes two stages: in - vitro modeling and clinical verification.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy volunteers; Patients with chronic airway disease requiring nebulization therapy.

排除标准

  • Those aged < 18 years; Refusing to participate in the study; Patients requiring invasive ventilator assisted breathing; Patients with artificial airways. Patients with chronic liver and kidney function injury. Allergic to radioactive elements.

结局指标

主要结局

In Vitro Model Pulmonary Deposition Rate

时间窗: Immediately after nebulization

Aerosol lung deposition rate calculated by in vitro model

Pulmonary Drug Deposition Rate

时间窗: Immediately after nebulization

Defined as the percentage of drug deposition in the lungs, relative to the whole inhalation volume

次要结局

未报告次要终点

研究者

发起方
Jingen Xia
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jingen Xia

Clinical Professor

China-Japan Friendship Hospital

研究点 (1)

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