NCT02764307

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

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable asthma

Timeline
Completed

Started Oct 2015

Status
completed

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

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 6, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

February 1, 2017

Status Verified

January 1, 2017

Enrollment Period

1 year

First QC Date

April 25, 2016

Last Update Submit

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

EXPERIMENTAL

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 nebulizerDevice: Breath enhanced nebulizerDevice: Manual-actuated nebulizerDevice: 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.

Aerosolized drug depositions

A breath enhanced nebulizer (Pari LC plus, Pari Inc., Germany) was tested with salbutamol sulfate powered by compressed gas flow at 6 L/min.

Aerosolized drug depositions

A manual-actuated nebulizer (A-T Neb, Atlantean Corporation, Taiwan) was tested with salbutamol sulfate powered by compressed gas flow at 6 L/min.

Aerosolized drug depositions

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

Aerosolized drug depositions

Eligibility Criteria

Age20 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Hui-Ling Lin, MSc

    Chang Gung University

    PRINCIPAL INVESTIGATOR

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