Inhaled Dose Analysis Using a Breath Actuated Nebulizer in Healthy Subjects
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Urinary salbutamol concentration
研究概览
简要总结
The goal of this crossover study is to compare urine drug concentrations using a continuous vibrating mesh nebulizer versus a breath-actuated vibrating mesh nebulizer in healthy volunteers. The main questions it aims to answer are:
- Whether breath-actuation nebulizer delivers higher inhaled drug dose, resulting in higher urine drug concentrations compared to continuous nebulization.
- Whether the different nebulizer modes deliver inhaled drug resulting in different effects on physiological parameters, including heart rate, respiratory rate, blood pressure, and blood oxygen saturation.
Participants will
- Inhale one dose (2.5mg) of salbutamol via continuous vs. breath-actuated nebulize mode.
- collect urine samples at multiple timepoints before and after nebulization to quantify drug elimination.
Researchers will compare the continuous and breath-actuated modes of vibrating mesh nebulizers to determine if breath-actuation improves drug delivery efficiency compared to continuous nebulization.
详细描述
Study Design and Objectives
This is a crossover study comparing two different nebulizer modes: continuous vibrating mesh nebulizer (cVMN, Microbase Inc.) vs. breath-actuated vibrating mesh nebulizer (bVMN, Microbase plus an actuated system) for bronchodilator delivery in 30 healthy volunteers. The primary objective is to compare urinary drug concentrations after inhalation between the two nebulizer modes to confirm an equivalent inhaled dose. Secondary objectives is to evaluate device safety based on vital sign changes and compare environmental drug particle concentrations between nebulizer modes.
Endpoints
The primary pharmacokinetic endpoint is urinary drug (salbutamol) concentration over 24 hours following nebulization with each mode. Secondary endpoints include pre- and post-nebulization vital signs (heart rate, blood pressure, respiratory rate, Saturation).
Study Procedures
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willing to sign a written informed consent form.
- •Healthy male and female participants aged >20 years.
- •Forced expiratory volume in the first second (FEV1) greater than 80% of the predicted value.
排除标准
- •Pregnant or lactating women.
- •Regular use of bronchodilators or inhaled medications.
- •History of bronchodilator allergy.
- •Hyperthyroidism.
- •Diabetes.
- •History of heart disease.
- •Arrhythmia.
- •Hypertension.
- •History of glaucoma, hypokalemia, or hyperglycemia.
- •Severe anemia.
- •Individuals with severe injuries or burns or limb amputation after breast surgery.
- •Open wounds or infectious dermatitis on the oral and facial regions.
- •Acute or infectious respiratory tract infections.
- •Currently taking any medications.
- •Respiratory therapy students.
结局指标
主要结局
Urinary salbutamol concentration
时间窗: Urine samples will be collected at 30 minutes before nebulization, at 30 minutes, and 24 hours after nebulization.
Quantitative measurement of salbutamol levels in urine samples at protocol-specified timepoints before and after nebulized bronchodilator administration using high performance liquid chromatography (HPLC).
次要结局
- Blood pressure(Blood pressure will be recorded from 5 minutes before, during, and 30 minutes after nebulization.)
- Heart rate(Heart rate will be recorded continuously from 5 minutes before, during, and 30 minutes, and after nebulization.)
- Saturation(Oxygen saturation will be recorded from 5 minutes before, during, and 30 minutes after nebulization.)
研究者
Hui-Ling Lin
Professor, Department of Respiratory Therapy
Chang Gung University