Inhaled Dose Analysis Using a Breath Actuated Nebulizer in Healthy Subjects

Summary

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.

Conditions

• Healthy Volunteers
• Aerosol Therapy
• Inhaled Drug Dose
• Pharmacogenomic Drug Interaction

Interventions

DEVICE

Breath-actuated vibrating mesh nebulizer

The intervention utilizes a breath-actuated vibrating mesh nebulizer system consisting of a controller module with microphone for respiratory phase detection and algorithm for inspiration triggering. This interfaces with the vibrating mesh nebulizer module which incorporates a micro-pump chip using piezoelectric effects to eject fluid through a mesh aperture plate holes. By detecting the onset of inspiration based on characteristic acoustic patterns using machine learning models, the controller module sends signals activating the piezoelectric vibration mechanism to generate aerosol only during the inspiratory phase through precision timing control, shutting off mist during expiration. The core module is attached to a standard commercial vibrating mesh nebulizer using the standard adult reusable mouthpiece interface.

DEVICE

Continuous vibrating mesh nebulizer

When the continuous vibrating mesh nebulizer powered on, the micro-pump chip provides sustained vibrations onto the aperture plate, forcing fluid through micron-scale pores under pressure to continuously produce aerosol throughout inspiration and expiration phase.

Sponsors & Collaborators

• National Tsing Hua University

  collaborator OTHER

• Chang Gung Memorial Hospital

  collaborator OTHER

• National Science and Technology Council

  collaborator FED

• Chang Gung University

  lead OTHER

Principal Investigators

• Hui-Ling Lin, PhD · Chang Gung University

• Li-Chun Chiu, MD, PhD · Linko Chang Gung Memorial Hospital

Study Design

Allocation

NON_RANDOMIZED

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

20 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-03-13

Primary Completion

2024-04-29

Completion

2024-05-01

Countries

• Taiwan

Study Locations