Aerosol Delivery in Different Types of Nebulizers

January 30, 2017 updated by: Hui-Ling Lin, Chang Gung University

Evaluation of Aerosol Delivery in Different Types of Nebulizers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 25 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Device: 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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inhaled and exhaled drug concentrations
Time Frame: Drug deposition was tested Immediately after each nebulization, expected average of 20 minutes
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
Time Frame: During each nebulization testing, an expected average of 10 minutes
Minute ventilation was recorded during nebulization
During each nebulization testing, an expected average of 10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2015

Primary Completion (ACTUAL)

October 1, 2016

Study Completion (ACTUAL)

December 1, 2016

Study Registration Dates

First Submitted

April 25, 2016

First Submitted That Met QC Criteria

May 5, 2016

First Posted (ESTIMATE)

May 6, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

February 1, 2017

Last Update Submitted That Met QC Criteria

January 30, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • ChangGungUniversity

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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