Aerosol Delivery in Different Types of Nebulizers
Evaluation of Aerosol Delivery in Different Types of Nebulizers
1 other identifier
interventional
10
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable asthma
Started Oct 2015
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 25, 2016
CompletedFirst Posted
Study publicly available on registry
May 6, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedFebruary 1, 2017
January 1, 2017
1 year
April 25, 2016
January 30, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Breathing parameters
During each nebulization testing, an expected average of 10 minutes
Study Arms (1)
Aerosolized drug depositions
EXPERIMENTALAerosol 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Healthy college subjects
You may not qualify if:
- Currently smoker
- History of asthma
- Drug allergy
- Pulmonary disease
- Heart disease
- Arrythmia
- Hyperthyroids
- Diabetes mellitus
- Lactacidosis
- Pregnant
- Under B-blocker medications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hui-Ling Lin, MSc
Chang Gung University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
April 25, 2016
First Posted
May 6, 2016
Study Start
October 1, 2015
Primary Completion
October 1, 2016
Study Completion
December 1, 2016
Last Updated
February 1, 2017
Record last verified: 2017-01