Aerosol Delivery in Different Types of Nebulizers

Study Overview
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Brief Summary
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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
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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: a constant jet nebulizer (Neb-easy, Galemed Corp., Taiwan); a breath enhanced nebulizer (Pari LC plus, Pari Inc., Germany); a manual-actuated nebulizer (A-T Neb, Atlantean Corporation, Taiwan); and a breath-actuated nebulizer (AeroElipes, Trudell Medical Inc, Canada) were evaluated.

Official Title
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Evaluation of Aerosol Delivery in Different Types of Nebulizers

Conditions
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Asthma

Intervention / Treatment
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* Device: Constant jet nebulizer
* Device: Breath enhanced nebulizer
* Device: Manual-actuated nebulizer
* Device: Breath-actuated nebulizer


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aerosolized drug depositions<br>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. | Device: Constant jet nebulizer<br>* A constant jet nebulizer (Neb-easy, Galemed Corp., Taiwan) was tested with salbutamol sulfate powered by compressed gas flow at 6 L/min.<br>Device: Breath enhanced nebulizer<br>* A breath enhanced nebulizer (Pari LC plus, Pari Inc., Germany) was tested with salbutamol sulfate powered by compressed gas flow at 6 L/min.<br>Device: Manual-actuated nebulizer<br>* A manual-actuated nebulizer (A-T Neb, Atlantean Corporation, Taiwan) was tested with salbutamol sulfate powered by compressed gas flow at 6 L/min.<br>Device: Breath-actuated nebulizer<br>* A breath-actuated nebulizer (AeroElipes, Trudell Medical Inc, Canada) was tested with salbutamol sulfate powered by compressed gas flow at 6 L/min.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inhaled and exhaled drug concentrations | Drug deposited on the collecting filter was analyzed. | Drug deposition was tested Immediately after each nebulization, expected average of 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breathing parameters | Minute ventilation was recorded during nebulization | During each nebulization testing, an expected average of 10 minutes |