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Completed

NCT Number: NCT02764307

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

20 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Constant jet nebulizer

Device

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

Device

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

Device

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

Device

A breath-actuated nebulizer (AeroElipes, Trudell Medical Inc, Canada) was tested with salbutamol sulfate powered by compressed gas flow at 6 L/min.

Primary outcomes

  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 outcomes

  1. Breathing parameters

    Time frame: During each nebulization testing, an expected average of 10 minutes

    Minute ventilation was recorded during nebulization

Sponsors and collaborators

Lead sponsor

Chang Gung University

Other

Registry information

Official study title

Evaluation of Aerosol Delivery in Different Types of Nebulizers

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 6, 2016
Registry last updated
Feb 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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