Inhaled Dose Analysis Using a Breath Actuated Nebulizer in Healthy Subjects

NCT06157515 | Completed

• 1 other identifier: BANinHealthy
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Vibrating Mesh Nebulizer; Breath-actuated Nebulization

Outcome Measures

Primary Outcomes (1)

• Urinary salbutamol concentration

  Quantitative measurement of salbutamol levels in urine samples at protocol-specified timepoints before and after nebulized bronchodilator administration using high performance liquid chromatography (HPLC).

  Urine samples will be collected at 30 minutes before nebulization, at 30 minutes, and 24 hours after nebulization.

Secondary Outcomes (3)

• Heart rate

  Heart rate will be recorded continuously from 5 minutes before, during, and 30 minutes, and after nebulization.

• Blood pressure

  Blood pressure will be recorded from 5 minutes before, during, and 30 minutes after nebulization.

• Saturation

  Oxygen saturation will be recorded from 5 minutes before, during, and 30 minutes after nebulization.

Study Arms (2)

continuous vibrating mesh nebulization (cVMN)

EXPERIMENTAL

Participants will inhale 2.5 mg salbutamol (from a 0.5 unit dose vial of Saldolin Inhalation Solution, Taiwan FDA approval number 043572) via the commercially available vibrating mesh nebulizer (Microbase, model number MBPN002). The device continuously generates aerosol throughout the respiratory cycle. Participants are encouraged to breathe with normal tidal breathing for up to 5 minutes until no aerosol is visually seen. No repeat or additional dosing is utilized.

Device: Continuous vibrating mesh nebulizer

Breath-actuated vibrating mesh nebulizer (bVMN)

EXPERIMENTAL

Participants will inhale 2.5 mg salbutamol (from a 0.5 unit dose vial of Saldolin Inhalation Solution, Taiwan FDA approval number 043572) via the commercially available vibrating mesh nebulizer (Microbase, model number MBPN002) with trigger module attachment. This device utilizes a microphone and algorithm to detect the inspiration to activate aerosol generation during period of inspiration only. Participants are encouraged to breathe with normal tidal breathing for up to 5 minutes until no aerosol is visually seen. No repeat or additional dosing is utilized.

Device: Breath-actuated vibrating mesh nebulizer

Interventions

Breath-actuated vibrating mesh nebulizer DEVICE

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.

Also known as: Microbase, Model Number MBPN002 with trigger system

Breath-actuated vibrating mesh nebulizer (bVMN)

Continuous vibrating mesh nebulizer DEVICE

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.

Also known as: Microbase, Model Number MBPN002

continuous vibrating mesh nebulization (cVMN)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnant or lactating women.
• Regular use of bronchodilators or inhaled medications.
• History of bronchodilator allergy.
• Hyperthyroidism.
• Diabetes.
• History of heart disease.
• Arrhythmia.
• Angina.
• 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.

Sponsors & Collaborators

• Chang Gung University: lead
• National Tsing Hua University: collaborator
• Chang Gung Memorial Hospital: collaborator
• National Science and Technology Council: collaborator

Study Sites (1)

Linkou Chang Gung Memorial Hospital

Taoyuan District, 33305, Taiwan

Location

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Study Officials

• Hui-Ling Lin, PhD

  Chang Gung University

  STUDY DIRECTOR

• Li-Chun Chiu, MD, PhD

  Linko Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Respiratory Therapy

Model Details: This is a prospective crossover interventional study comparing two vibrating mesh nebulizer modalities - continuous versus breath-actuated - for delivering a bronchodilator, tested in healthy adult volunteers. Participants will receive an approved therapeutic dosage (2.5 mg salbutamol) via both devices in an alternating sequence. Outcome measurements focus on pharmacokinetic results, specifically urinary drug recovery.

Study Record Dates

• First Submitted: November 25, 2023
• First Posted: December 6, 2023
• Study Start: March 13, 2024
• Primary Completion: April 29, 2024
• Study Completion: May 1, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)