AsthmaNCT02764307
Aerosol Delivery in Different Types of Nebulizers
A study testing Constant jet nebulizer, Breath enhanced nebulizer and Manual-actuated nebulizer in people with Asthma, run by Chang Gung University.
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. Read more about this study
- Who is it for?
- Ages 20 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Constant jet nebulizer, Breath enhanced nebulizer and Manual-actuated nebulizer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy college subjects
Who cannot join
- Currently smoker
- History of asthma
- Drug allergy
- Pulmonary disease
- Heart disease
- Arrythmia
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- Hyperthyroids
- Diabetes mellitus
- Lactacidosis
- Pregnant
- Under B-blocker medications
About this study
Official title: Evaluation of 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.
Read the 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:
- 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.
- Conditions
- Asthma
- Being tested
- Constant jet nebulizer, Breath enhanced nebulizer, Manual-actuated nebulizer, Breath-actuated nebulizer
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Constant jet nebulizerDevice
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 nebulizerDevice
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 nebulizerDevice
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 nebulizerDevice
A breath-actuated nebulizer (AeroElipes, Trudell Medical Inc, Canada) was tested with salbutamol sulfate powered by compressed gas flow at 6 L/min.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Constant jet nebulizer; Device: Breath enhanced nebulizer; Device: Manual-actuated nebulizer; Device: Breath-actuated nebulizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inhaled and exhaled drug concentrations
Drug deposited on the collecting filter was analyzed.
Measured: Drug deposition was tested Immediately after each nebulization, expected average of 20 minutes
Secondary outcomes (1)
Breathing parameters
Minute ventilation was recorded during nebulization
Measured: During each nebulization testing, an expected average of 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2016 (estimated)
- Study startOct 2015
- Primary completionOct 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui-Ling Lin, Chang Gung University
- Investigators
- Hui-Ling Lin, MSc, Principal investigator, Chang Gung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02764307
- Sponsor's protocol ID
- ChangGungUniversity
- Status last verified
- Jan 2017
- First submitted
- 25 Apr 2016
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Aerosol Delivery in Different Types of Nebulizers
- ClinicalTrials.gov ID
- NCT02764307
- Acronym / sponsor ID
- ChangGungUniversity
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Chang Gung UniversityUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 6 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aerosolized drug depositions | Experimental | Device: Constant jet nebulizer, Device: Breath enhanced nebulizer, Device: Manual-actuated nebulizer, Device: Breath-actuated nebulizerAerosol 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. |
Who may qualify
- Ages
- 20 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy college subjects
Key exclusion criteria (11 listed)
- Currently smoker
- History of asthma
- Drug allergy
- Pulmonary disease
- Heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Constant jet nebulizerA constant jet nebulizer (Neb-easy, Galemed Corp., Taiwan) was tested with salbutamol sulfate powered by compressed gas flow at 6 L/min. | Device | Aerosolized drug depositions |
| Breath enhanced nebulizerA breath enhanced nebulizer (Pari LC plus, Pari Inc., Germany) was tested with salbutamol sulfate powered by compressed gas flow at 6 L/min. | Device | Aerosolized drug depositions |
| Manual-actuated nebulizerA manual-actuated nebulizer (A-T Neb, Atlantean Corporation, Taiwan) was tested with salbutamol sulfate powered by compressed gas flow at 6 L/min. | Device | Aerosolized drug depositions |
| Breath-actuated nebulizerA breath-actuated nebulizer (AeroElipes, Trudell Medical Inc, Canada) was tested with salbutamol sulfate powered by compressed gas flow at 6 L/min. | Device | Aerosolized drug depositions |
Primary outcome
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.
1 secondary outcome
Breathing parameters
Time frame: During each nebulization testing, an expected average of 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hui-Ling Lin, MSc principal investigator
Chang Gung University
Questions about this trial
What is this clinical trial studying?
A study testing Constant jet nebulizer, Breath enhanced nebulizer and Manual-actuated nebulizer in people with Asthma, run by Chang Gung University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inhaled and exhaled drug concentrations (time frame: Drug deposition was tested Immediately after each nebulization, expected average of 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2017.