Aerosol Delivery in Different Types of Nebulizers

Asthma Clinical Trial

Official title:

Evaluation of Aerosol Delivery in Different Types of Nebulizers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02764307
• Other study ID #: ChangGungUniversity
• Status: Completed
• Phase: N/A
• First received: April 25, 2016
• Last updated: January 30, 2017
• Start date: October 2015
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: Chang Gung University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Breathing parameters	Minute ventilation was recorded during nebulization	During each nebulization testing, an expected average of 10 minutes