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Aerosol Delivery in Different Types of Nebulizers

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ClinicalTrials.gov Identifier: NCT02764307
Recruitment Status : Completed
First Posted : May 6, 2016
Last Update Posted : February 1, 2017
Sponsor:
Information provided by (Responsible Party):
Hui-Ling Lin, Chang Gung University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Asthma Device: Constant jet nebulizer Device: Breath enhanced nebulizer Device: Manual-actuated nebulizer Device: Breath-actuated nebulizer Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Evaluation of Aerosol Delivery in Different Types of Nebulizers
Actual Study Start Date : October 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : December 2016
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Breathing parameters [ Time Frame: During each nebulization testing, an expected average of 10 minutes ]
    Minute ventilation was recorded during nebulization


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02764307


Sponsors and Collaborators
Chang Gung University
Investigators
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Principal Investigator: Hui-Ling Lin, MSc Chang Gung University
More Information
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Responsible Party: Hui-Ling Lin, Assistant professor, Chang Gung University
ClinicalTrials.gov Identifier: NCT02764307    
Other Study ID Numbers: ChangGungUniversity
First Posted: May 6, 2016    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided