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
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:
- 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.
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.
|
A constant jet nebulizer (Neb-easy, Galemed Corp., Taiwan) was tested with salbutamol sulfate powered by compressed gas flow at 6 L/min.
A breath enhanced nebulizer (Pari LC plus, Pari Inc., Germany) was tested with salbutamol sulfate powered by compressed gas flow at 6 L/min.
A manual-actuated nebulizer (A-T Neb, Atlantean Corporation, Taiwan) was tested with salbutamol sulfate powered by compressed gas flow at 6 L/min.
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
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.