Aerosol Delivery in Different Types of Nebulizers

Not Applicable

Completed

• Conditions: Asthma
• Interventions: Device: Constant jet nebulizer; Device: Breath enhanced nebulizer; Device: Manual-actuated nebulizer; Device: Breath-actuated nebulizer

• Registration Number: NCT02764307
• Lead Sponsor: Chang Gung University

Brief Summary

Background: Nebulizers design influences efficiency of aerosol delivery. Performance of nebulizers is commonly tested by breathing simulators with static parameters. However, breathing patterns vary in adults.

Objectives: The purpose of this study was to evaluate drug deposition of different types of nebulizers testing with breathing patterns of healthy subjects.

Detailed Description

Material and Methods

The study was approved by Chang Gung Memorial Foundation Institutional Review Broad. Ten healthy subjects, aged 20.6±0.5 years, were recruited. Four nebulizers:

1. a constant jet nebulizer (Neb-easy, Galemed Corp., Taiwan);

2. a breath enhanced nebulizer (Pari LC plus, Pari Inc., Germany);

3. a manual-actuated nebulizer (A-T Neb, Atlantean Corporation, Taiwan); and

4. a breath-actuated nebulizer (AeroElipes, Trudell Medical Inc, Canada) were evaluated.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2016-04-25
• Study First Submitted QC: 2016-05-05
• Study First Posted: 2016-05-06
• Primary Completion: 2016-10
• Study Completion: 2016-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-30
• Last Update Posted: 2017-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Healthy college subjects

Exclusion Criteria

• Currently smoker
• History of asthma
• Drug allergy
• Pulmonary disease
• Heart disease
• Arrythmia
• Hyperthyroids
• Diabetes mellitus
• Lactacidosis
• Pregnant
• Under B-blocker medications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aerosolized drug depositions	Constant jet nebulizer	Aerosol drug deposited on the inhaled and exhaled filters and the residual dose were evaluated delivered by four types of nebulizer: 1) a constant jet nebulizer, a breath enhanced nebulizer, a manual-actuated nebulizer, and a breath-actuated nebulizer.
Aerosolized drug depositions	Breath enhanced nebulizer	Aerosol drug deposited on the inhaled and exhaled filters and the residual dose were evaluated delivered by four types of nebulizer: 1) a constant jet nebulizer, a breath enhanced nebulizer, a manual-actuated nebulizer, and a breath-actuated nebulizer.
Aerosolized drug depositions	Manual-actuated nebulizer	Aerosol drug deposited on the inhaled and exhaled filters and the residual dose were evaluated delivered by four types of nebulizer: 1) a constant jet nebulizer, a breath enhanced nebulizer, a manual-actuated nebulizer, and a breath-actuated nebulizer.
Aerosolized drug depositions	Breath-actuated nebulizer	Aerosol drug deposited on the inhaled and exhaled filters and the residual dose were evaluated delivered by four types of nebulizer: 1) a constant jet nebulizer, a breath enhanced nebulizer, a manual-actuated nebulizer, and a breath-actuated nebulizer.

Primary Outcome Measures

Name	Time	Method
Inhaled and exhaled drug concentrations	Drug deposition was tested Immediately after each nebulization, expected average of 20 minutes	Drug deposited on the collecting filter was analyzed.

Secondary Outcome Measures

Name	Time	Method
Breathing parameters	During each nebulization testing, an expected average of 10 minutes	Minute ventilation was recorded during nebulization