Aerosol Delivery in Different Types of Nebulizers

NCT ID: NCT02764307

Last Updated: 2017-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-12-31

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:

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.

Conditions

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Asthma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Aerosolized drug depositions

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.

Group Type EXPERIMENTAL

Constant jet nebulizer

Intervention Type DEVICE

A constant jet nebulizer (Neb-easy, Galemed Corp., Taiwan) was tested with salbutamol sulfate powered by compressed gas flow at 6 L/min.

Breath enhanced nebulizer

Intervention Type DEVICE

A breath enhanced nebulizer (Pari LC plus, Pari Inc., Germany) was tested with salbutamol sulfate powered by compressed gas flow at 6 L/min.

Manual-actuated nebulizer

Intervention Type DEVICE

A manual-actuated nebulizer (A-T Neb, Atlantean Corporation, Taiwan) was tested with salbutamol sulfate powered by compressed gas flow at 6 L/min.

Breath-actuated nebulizer

Intervention Type DEVICE

A breath-actuated nebulizer (AeroElipes, Trudell Medical Inc, Canada) was tested with salbutamol sulfate powered by compressed gas flow at 6 L/min.

Interventions

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Constant jet nebulizer

A constant jet nebulizer (Neb-easy, Galemed Corp., Taiwan) was tested with salbutamol sulfate powered by compressed gas flow at 6 L/min.

Intervention Type DEVICE

Breath enhanced nebulizer

A breath enhanced nebulizer (Pari LC plus, Pari Inc., Germany) was tested with salbutamol sulfate powered by compressed gas flow at 6 L/min.

Intervention Type DEVICE

Manual-actuated nebulizer

A manual-actuated nebulizer (A-T Neb, Atlantean Corporation, Taiwan) was tested with salbutamol sulfate powered by compressed gas flow at 6 L/min.

Intervention Type DEVICE

Breath-actuated nebulizer

A breath-actuated nebulizer (AeroElipes, Trudell Medical Inc, Canada) was tested with salbutamol sulfate powered by compressed gas flow at 6 L/min.

Intervention Type DEVICE

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chang Gung University

OTHER

Sponsor Role lead

Responsible Party

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Hui-Ling Lin

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hui-Ling Lin, MSc

Role: PRINCIPAL_INVESTIGATOR

Chang Gung University

Other Identifiers

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ChangGungUniversity

Identifier Type: -

Identifier Source: org_study_id

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