Healthy VolunteersNCT06157515
Inhaled Dose Analysis Using a Breath Actuated Nebulizer in Healthy Subjects
A study testing Breath-actuated vibrating mesh nebulizer and Continuous vibrating mesh nebulizer in people with Healthy Volunteers and Aerosol Therapy, run by Chang Gung University at 1 site in Taiwan.
Trial summary
The goal of this crossover study is to compare urine drug concentrations using a continuous vibrating mesh nebulizer versus a breath-actuated vibrating mesh nebulizer in healthy volunteers. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Aerosol Therapy, Inhaled Drug Dose
- What is being tested?
- Breath-actuated vibrating mesh nebulizer and Continuous vibrating mesh nebulizer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteTaiwan
- Study dates
- 13 Mar 2024to 1 May 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willing to sign a written informed consent form.
- Healthy male and female participants aged >20 years.
- Forced expiratory volume in the first second (FEV1) greater than 80% of the predicted value.
Who cannot join
- Pregnant or lactating women.
- Regular use of bronchodilators or inhaled medications.
- History of bronchodilator allergy.
- Hyperthyroidism.
- Diabetes.
- History of heart disease.
Show all 16Show fewer
- Arrhythmia.
- Angina.
- Hypertension.
- History of glaucoma, hypokalemia, or hyperglycemia.
- Severe anemia.
- Individuals with severe injuries or burns or limb amputation after breast surgery.
- Open wounds or infectious dermatitis on the oral and facial regions.
- Acute or infectious respiratory tract infections.
- Currently taking any medications.
- Respiratory therapy students.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this crossover study is to compare urine drug concentrations using a continuous vibrating mesh nebulizer versus a breath-actuated vibrating mesh nebulizer in healthy volunteers. The main questions it aims to answer are:
- Whether breath-actuation nebulizer delivers higher inhaled drug dose, resulting in higher urine drug concentrations compared to continuous nebulization.
- Whether the different nebulizer modes deliver inhaled drug resulting in different effects on physiological parameters, including heart rate, respiratory rate, blood pressure, and blood oxygen saturation.
Read more
Participants will
- Inhale one dose (2.5mg) of salbutamol via continuous vs. breath-actuated nebulize mode.
- collect urine samples at multiple timepoints before and after nebulization to quantify drug elimination.
Researchers will compare the continuous and breath-actuated modes of vibrating mesh nebulizers to determine if breath-actuation improves drug delivery efficiency compared to continuous nebulization.
Read the detailed description
Study Design and Objectives
This is a crossover study comparing two different nebulizer modes: continuous vibrating mesh nebulizer (cVMN, Microbase Inc.) vs. breath-actuated vibrating mesh nebulizer (bVMN, Microbase plus an actuated system) for bronchodilator delivery in 30 healthy volunteers. The primary objective is to compare urinary drug concentrations after inhalation between the two nebulizer modes to confirm an equivalent inhaled dose. Secondary objectives is to evaluate device safety based on vital sign changes and compare environmental drug particle concentrations between nebulizer modes.
Endpoints
The primary pharmacokinetic endpoint is urinary drug (salbutamol) concentration over 24 hours following nebulization with each mode. Secondary endpoints include pre- and post-nebulization vital signs (heart rate, blood pressure, respiratory rate, Saturation).
Study Procedures
Participants meeting the eligibility criteria will be assigned either to the continuous vibrating mesh nebulizer (cVMN) or the breath-actuated vibrating mesh nebulizer (bVMN). At visit 1, a baseline urine sample will be collected, followed by nebulization with a 0.5-unit dose (2.5 mg/1.25 mL salbutamol). Participants will inhale with normal tidal breathing for up to 5 minutes until the aerosol is visually seen. Vital signs will be continuously monitored every 5 minutes until 30 minutes after nebulization. Environmental particle concentration will be continuously measured by an aerosol spectrometer. Urine samples will be obtained 30 minutes before, 30 minutes after, and 24 hours post-nebulization. Visit 2 will follow identical procedures with the alternate nebulizer mode after a 1-week washout period.
Device Details
The cVMN is a commercially available continuous vibrating mesh nebulizer registered with the Taiwan Food and Drug Administration (device number 004561). The bVMN system incorporates a proprietary trigger module to enable breath-actuated delivery synchronized during inspiration. This module includes microphone detection during inspiration and expiration phases, along with software control of nebulization activation. Both devices utilize the same core nebulizer hardware and mesh component for aerosol generation.
Data Collection and Statistics
Urine samples will be extracted and analysis by HPLC to quantify salbutamol levels. Statistical analysis will include paired t-tests or nonparametric tests as appropriate to compare pharmacokinetic parameters, environmental concentrations, and vital signs changes between the two nebulize modes. Linear regression will also correlate urinary drug levels with nominal dose. The level of significance will be p<0.05.
- Being tested
- Breath-actuated vibrating mesh nebulizer, Continuous vibrating mesh nebulizer
- Keywords
- Vibrating Mesh Nebulizer, Breath-actuated Nebulization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breath-actuated vibrating mesh nebulizerDevice
Also called Microbase, Model Number MBPN002 with trigger system
The intervention utilizes a breath-actuated vibrating mesh nebulizer system consisting of a controller module with microphone for respiratory phase detection and algorithm for inspiration triggering. This interfaces with the vibrating mesh nebulizer module which incorporates a micro-pump chip using piezoelectric effects to eject fluid through a mesh aperture plate holes. By detecting the onset of inspiration based on characteristic acoustic patterns using machine learning models, the controller module sends signals activating the piezoelectric vibration mechanism to generate aerosol only during the inspiratory phase through precision timing control, shutting off mist during expiration. The core module is attached to a standard commercial vibrating mesh nebulizer using the standard adult reusable mouthpiece interface.
Continuous vibrating mesh nebulizerDevice
Also called Microbase, Model Number MBPN002
When the continuous vibrating mesh nebulizer powered on, the micro-pump chip provides sustained vibrations onto the aperture plate, forcing fluid through micron-scale pores under pressure to continuously produce aerosol throughout inspiration and expiration phase.
| Study group | Role | What they receive |
|---|---|---|
| continuous vibrating mesh nebulization (cVMN) | Experimental | Participants will inhale 2.5 mg salbutamol (from a 0.5 unit dose vial of Saldolin Inhalation Solution, Taiwan FDA approval number 043572) via the commercially available vibrating mesh nebulizer (Microbase, model number MBPN002). The device continuously generates aerosol throughout the respiratory cycle. Participants are encouraged to breathe with normal tidal breathing for up to 5 minutes until no aerosol is visually seen. No repeat or additional dosing is utilized. Receives: Device: Continuous vibrating mesh nebulizer |
| Breath-actuated vibrating mesh nebulizer (bVMN) | Experimental | Participants will inhale 2.5 mg salbutamol (from a 0.5 unit dose vial of Saldolin Inhalation Solution, Taiwan FDA approval number 043572) via the commercially available vibrating mesh nebulizer (Microbase, model number MBPN002) with trigger module attachment. This device utilizes a microphone and algorithm to detect the inspiration to activate aerosol generation during period of inspiration only. Participants are encouraged to breathe with normal tidal breathing for up to 5 minutes until no aerosol is visually seen. No repeat or additional dosing is utilized. Receives: Device: Breath-actuated vibrating mesh nebulizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary salbutamol concentration
Quantitative measurement of salbutamol levels in urine samples at protocol-specified timepoints before and after nebulized bronchodilator administration using high performance liquid chromatography (HPLC).
Measured: Urine samples will be collected at 30 minutes before nebulization, at 30 minutes, and 24 hours after nebulization.
Secondary outcomes (3)
Heart rate
Heart rate measured via continuous telemetry
Measured: Heart rate will be recorded continuously from 5 minutes before, during, and 30 minutes, and after nebulization.
Blood pressure
Systolic and diastolic blood pressure
Measured: Blood pressure will be recorded from 5 minutes before, during, and 30 minutes after nebulization.
Saturation
Oxygen saturation using a pulse oximeter.
Measured: Oxygen saturation will be recorded from 5 minutes before, during, and 30 minutes after nebulization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start13 Mar 2024
- Primary completion29 Apr 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies 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
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- This is a prospective crossover interventional study comparing two vibrating mesh nebulizer modalities - continuous versus breath-actuated - for delivering a bronchodilator, tested in healthy adult volunteers. Participants will receive an approved therapeutic dosage (2.5 mg salbutamol) via both devices in an alternating sequence. Outcome measurements focus on pharmacokinetic results, specifically urinary drug recovery.
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung University
- Sponsor type
- University, hospital or other
- Collaborators
- National Tsing Hua University, Chang Gung Memorial Hospital, National Science and Technology Council
- Responsible party
- Principal investigator, Hui-Ling Lin, Chang Gung University
- Investigators
- Hui-Ling Lin, PhD, Study director, Chang Gung UniversityLi-Chun Chiu, MD, PhD, Principal investigator, Linko Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06157515
- Sponsor's protocol ID
- BANinHealthy
- Status last verified
- Sep 2024
- First submitted
- 25 Nov 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lipworth BJ. Pharmacokinetics of inhaled drugs. Br J Clin Pharmacol. 1996 Dec;42(6):697-705. doi: 10.1046/j.1365-2125.1996.00493.x.
PubMed 8971424Dolovich MB, Dhand R. Aerosol drug delivery: developments in device design and clinical use. Lancet. 2011 Mar 19;377(9770):1032-45. doi: 10.1016/S0140-6736(10)60926-9. Epub 2010 Oct 29.
PubMed 21036392Yeo LY, Friend JR, McIntosh MP, Meeusen EN, Morton DA. Ultrasonic nebulization platforms for pulmonary drug delivery. Expert Opin Drug Deliv. 2010 Jun;7(6):663-79. doi: 10.1517/17425247.2010.485608.
PubMed 20459360Dhand R. New frontiers in aerosol delivery during mechanical ventilation. Respir Care. 2004 Jun;49(6):666-77.
PubMed 15165301Kern DG, Frumkin H. Asthma in respiratory therapists. Ann Intern Med. 1989 May 15;110(10):767-73. doi: 10.7326/0003-4819-110-10-767.
PubMed 2712460Christiani DC, Kern DG. Asthma risk and occupation as a respiratory therapist. Am Rev Respir Dis. 1993 Sep;148(3):671-4. doi: 10.1164/ajrccm/148.3.671.
PubMed 8368639Dimich-Ward H, Wymer ML, Chan-Yeung M. Respiratory health survey of respiratory therapists. Chest. 2004 Oct;126(4):1048-53. doi: 10.1378/chest.126.4.1048.
PubMed 15486362Dhand R. Intelligent nebulizers in the age of the Internet: The I-neb Adaptive Aerosol Delivery (AAD) system. J Aerosol Med Pulm Drug Deliv. 2010 Apr;23 Suppl 1(Suppl 1):iii-v. doi: 10.1089/jamp.2010.0818. No abstract available.
PubMed 20373913Denyer J, Dyche T. The Adaptive Aerosol Delivery (AAD) technology: Past, present, and future. J Aerosol Med Pulm Drug Deliv. 2010 Apr;23 Suppl 1(Suppl 1):S1-10. doi: 10.1089/jamp.2009.0791.
PubMed 20373904Chamberlain D, Kodgule R, Ganelin D, Miglani V, Fletcher RR. Application of semi-supervised deep learning to lung sound analysis. Annu Int Conf IEEE Eng Med Biol Soc. 2016 Aug;2016:804-807. doi: 10.1109/EMBC.2016.7590823.
PubMed 28324938Islam MA, Bandyopadhyaya I, Bhattacharyya P, Saha G. Multichannel lung sound analysis for asthma detection. Comput Methods Programs Biomed. 2018 Jun;159:111-123. doi: 10.1016/j.cmpb.2018.03.002. Epub 2018 Mar 9.
PubMed 29650306Messner E, Fediuk M, Swatek P, Scheidl S, Smolle-Juttner FM, Olschewski H, Pernkopf F. Multi-channel lung sound classification with convolutional recurrent neural networks. Comput Biol Med. 2020 Jul;122:103831. doi: 10.1016/j.compbiomed.2020.103831. Epub 2020 May 23.
PubMed 32658732Seren E. Frequency spectra of normal expiratory nasal sound. Am J Rhinol. 2005 May-Jun;19(3):257-61.
PubMed 16011131Sen I, Saraclar M, Kahya YP. A Comparison of SVM and GMM-Based Classifier Configurations for Diagnostic Classification of Pulmonary Sounds. IEEE Trans Biomed Eng. 2015 Jul;62(7):1768-76. doi: 10.1109/TBME.2015.2403616. Epub 2015 Feb 12.
PubMed 25700439Charleston-Villalobos S, Martinez-Hernandez G, Gonzalez-Camarena R, Chi-Lem G, Carrillo JG, Aljama-Corrales T. Assessment of multichannel lung sounds parameterization for two-class classification in interstitial lung disease patients. Comput Biol Med. 2011 Jul;41(7):473-82. doi: 10.1016/j.compbiomed.2011.04.009. Epub 2011 May 14.
PubMed 21571265
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhaled Dose Analysis Using a Breath Actuated Nebulizer in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06157515
- Acronym / sponsor ID
- BANinHealthy
- Keywords
- Vibrating Mesh Nebulizer, Breath-actuated Nebulization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Chang Gung UniversityUniversity, hospital or other
- Collaborators
- National Tsing Hua University, Chang Gung Memorial Hospital, National Science and Technology Council
- Study start
- 13 Mar 2024 (actual)
- Primary completion
- 29 Apr 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 6 Dec 2023 (actual)
- 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.
The goal of this crossover study is to compare urine drug concentrations using a continuous vibrating mesh nebulizer versus a breath-actuated vibrating mesh nebulizer in healthy volunteers. The main questions it aims to answer are:
- Whether breath-actuation nebulizer delivers higher inhaled drug dose, resulting in higher urine drug concentrations compared to continuous nebulization.
- Whether the different nebulizer modes deliver inhaled drug resulting in different effects on physiological parameters, including heart rate, respiratory rate, blood pressure, and blood oxygen saturation.
Participants will
- Inhale one dose (2.5mg) of salbutamol via continuous vs. breath-actuated nebulize mode.
- collect urine samples at multiple timepoints before and after nebulization to quantify drug elimination.
Researchers will compare the continuous and breath-actuated modes of vibrating mesh nebulizers to determine if breath-actuation improves drug delivery efficiency compared to continuous nebulization.
Detailed description
Study Design and Objectives
This is a crossover study comparing two different nebulizer modes: continuous vibrating mesh nebulizer (cVMN, Microbase Inc.) vs. breath-actuated vibrating mesh nebulizer (bVMN, Microbase plus an actuated system) for bronchodilator delivery in 30 healthy volunteers. The primary objective is to compare urinary drug concentrations after inhalation between the two nebulizer modes to confirm an equivalent inhaled dose. Secondary objectives is to evaluate device safety based on vital sign changes and compare environmental drug particle concentrations between nebulizer modes.
Endpoints
The primary pharmacokinetic endpoint is urinary drug (salbutamol) concentration over 24 hours following nebulization with each mode. Secondary endpoints include pre- and post-nebulization vital signs (heart rate, blood pressure, respiratory rate, Saturation).
Study Procedures
Participants meeting the eligibility criteria will be assigned either to the continuous vibrating mesh nebulizer (cVMN) or the breath-actuated vibrating mesh nebulizer (bVMN). At visit 1, a baseline urine sample will be collected, followed by nebulization with a 0.5-unit dose (2.5 mg/1.25 mL salbutamol). Participants will inhale with normal tidal breathing for up to 5 minutes until the aerosol is visually seen. Vital signs will be continuously monitored every 5 minutes until 30 minutes after nebulization. Environmental particle concentration will be continuously measured by an aerosol spectrometer. Urine samples will be obtained 30 minutes before, 30 minutes after, and 24 hours post-nebulization. Visit 2 will follow identical procedures with the alternate nebulizer mode after a 1-week washout period.
Device Details
The cVMN is a commercially available continuous vibrating mesh nebulizer registered with the Taiwan Food and Drug Administration (device number 004561). The bVMN system incorporates a proprietary trigger module to enable breath-actuated delivery synchronized during inspiration. This module includes microphone detection during inspiration and expiration phases, along with software control of nebulization activation. Both devices utilize the same core nebulizer hardware and mesh component for aerosol generation.
Data Collection and Statistics
Urine samples will be extracted and analysis by HPLC to quantify salbutamol levels. Statistical analysis will include paired t-tests or nonparametric tests as appropriate to compare pharmacokinetic parameters, environmental concentrations, and vital signs changes between the two nebulize modes. Linear regression will also correlate urinary drug levels with nominal dose. The level of significance will be p<0.05.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a prospective crossover interventional study comparing two vibrating mesh nebulizer modalities - continuous versus breath-actuated - for delivering a bronchodilator, tested in healthy adult volunteers. Participants will receive an approved therapeutic dosage (2.5 mg salbutamol) via both devices in an alternating sequence. Outcome measurements focus on pharmacokinetic results, specifically urinary drug recovery.
| Arm | Type | Receives |
|---|---|---|
| continuous vibrating mesh nebulization (cVMN) | Experimental | Device: Continuous vibrating mesh nebulizerParticipants will inhale 2.5 mg salbutamol (from a 0.5 unit dose vial of Saldolin Inhalation Solution, Taiwan FDA approval number 043572) via the commercially available vibrating mesh nebulizer (Microbase, model number MBPN002). The device continuously generates aerosol throughout the respiratory cycle. Participants are encouraged to breathe with normal tidal breathing for up to 5 minutes until no aerosol is visually seen. No repeat or additional dosing is utilized. |
| Breath-actuated vibrating mesh nebulizer (bVMN) | Experimental | Device: Breath-actuated vibrating mesh nebulizerParticipants will inhale 2.5 mg salbutamol (from a 0.5 unit dose vial of Saldolin Inhalation Solution, Taiwan FDA approval number 043572) via the commercially available vibrating mesh nebulizer (Microbase, model number MBPN002) with trigger module attachment. This device utilizes a microphone and algorithm to detect the inspiration to activate aerosol generation during period of inspiration only. Participants are encouraged to breathe with normal tidal breathing for up to 5 minutes until no aerosol is visually seen. No repeat or additional dosing is utilized. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Willing to sign a written informed consent form.
- Healthy male and female participants aged >20 years.
- Forced expiratory volume in the first second (FEV1) greater than 80% of the predicted value.
Key exclusion criteria (16 listed)
- Pregnant or lactating women.
- Regular use of bronchodilators or inhaled medications.
- History of bronchodilator allergy.
- Hyperthyroidism.
- Diabetes.
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 |
|---|---|---|
| Breath-actuated vibrating mesh nebulizerAlso: Microbase, Model Number MBPN002 with trigger systemThe intervention utilizes a breath-actuated vibrating mesh nebulizer system consisting of a controller module with microphone for respiratory phase detection and algorithm for inspiration triggering. This interfaces with the vibrating mesh nebulizer module which incorporates a micro-pump chip using piezoelectric effects to eject fluid through a mesh aperture plate holes. By detecting the onset of inspiration based on characteristic acoustic patterns using machine learning models, the controller module sends signals activating the piezoelectric vibration mechanism to generate aerosol only during the inspiratory phase through precision timing control, shutting off mist during expiration. The core module is attached to a standard commercial vibrating mesh nebulizer using the standard adult reusable mouthpiece interface. | Device | Breath-actuated vibrating mesh nebulizer (bVMN) |
| Continuous vibrating mesh nebulizerAlso: Microbase, Model Number MBPN002When the continuous vibrating mesh nebulizer powered on, the micro-pump chip provides sustained vibrations onto the aperture plate, forcing fluid through micron-scale pores under pressure to continuously produce aerosol throughout inspiration and expiration phase. | Device | continuous vibrating mesh nebulization (cVMN) |
Primary outcome
Urinary salbutamol concentration
Time frame: Urine samples will be collected at 30 minutes before nebulization, at 30 minutes, and 24 hours after nebulization.
Quantitative measurement of salbutamol levels in urine samples at protocol-specified timepoints before and after nebulized bronchodilator administration using high performance liquid chromatography (HPLC).
3 secondary outcomes
Heart rate
Time frame: Heart rate will be recorded continuously from 5 minutes before, during, and 30 minutes, and after nebulization.
Blood pressure
Time frame: Blood pressure will be recorded from 5 minutes before, during, and 30 minutes after nebulization.
Saturation
Time frame: Oxygen saturation will be recorded from 5 minutes before, during, and 30 minutes after nebulization.
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 19 Sep 2024.
- Background: PubMed 8971424Lipworth BJ. Pharmacokinetics of inhaled drugs. Br J Clin Pharmacol. 1996 Dec;42(6):697-705. doi: 10.1046/j.1365-2125.1996.00493.x.
- Background: PubMed 21036392Dolovich MB, Dhand R. Aerosol drug delivery: developments in device design and clinical use. Lancet. 2011 Mar 19;377(9770):1032-45. doi: 10.1016/S0140-6736(10)60926-9. Epub 2010 Oct 29.
- Background: PubMed 20459360Yeo LY, Friend JR, McIntosh MP, Meeusen EN, Morton DA. Ultrasonic nebulization platforms for pulmonary drug delivery. Expert Opin Drug Deliv. 2010 Jun;7(6):663-79. doi: 10.1517/17425247.2010.485608.
- Background: PubMed 15165301Dhand R. New frontiers in aerosol delivery during mechanical ventilation. Respir Care. 2004 Jun;49(6):666-77.
- Background: PubMed 2712460Kern DG, Frumkin H. Asthma in respiratory therapists. Ann Intern Med. 1989 May 15;110(10):767-73. doi: 10.7326/0003-4819-110-10-767.
- Background: PubMed 8368639Christiani DC, Kern DG. Asthma risk and occupation as a respiratory therapist. Am Rev Respir Dis. 1993 Sep;148(3):671-4. doi: 10.1164/ajrccm/148.3.671.
- Background: PubMed 15486362Dimich-Ward H, Wymer ML, Chan-Yeung M. Respiratory health survey of respiratory therapists. Chest. 2004 Oct;126(4):1048-53. doi: 10.1378/chest.126.4.1048.
- Background: PubMed 20373913Dhand R. Intelligent nebulizers in the age of the Internet: The I-neb Adaptive Aerosol Delivery (AAD) system. J Aerosol Med Pulm Drug Deliv. 2010 Apr;23 Suppl 1(Suppl 1):iii-v. doi: 10.1089/jamp.2010.0818. No abstract available.
- Background: PubMed 20373904Denyer J, Dyche T. The Adaptive Aerosol Delivery (AAD) technology: Past, present, and future. J Aerosol Med Pulm Drug Deliv. 2010 Apr;23 Suppl 1(Suppl 1):S1-10. doi: 10.1089/jamp.2009.0791.
- Background: PubMed 28324938Chamberlain D, Kodgule R, Ganelin D, Miglani V, Fletcher RR. Application of semi-supervised deep learning to lung sound analysis. Annu Int Conf IEEE Eng Med Biol Soc. 2016 Aug;2016:804-807. doi: 10.1109/EMBC.2016.7590823.
- Background: PubMed 29650306Islam MA, Bandyopadhyaya I, Bhattacharyya P, Saha G. Multichannel lung sound analysis for asthma detection. Comput Methods Programs Biomed. 2018 Jun;159:111-123. doi: 10.1016/j.cmpb.2018.03.002. Epub 2018 Mar 9.
- Background: PubMed 32658732Messner E, Fediuk M, Swatek P, Scheidl S, Smolle-Juttner FM, Olschewski H, Pernkopf F. Multi-channel lung sound classification with convolutional recurrent neural networks. Comput Biol Med. 2020 Jul;122:103831. doi: 10.1016/j.compbiomed.2020.103831. Epub 2020 May 23.
- Individual participant dataSharing planned: No
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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, PhD study director
Chang Gung University
Li-Chun Chiu, MD, PhD principal investigator
Linko Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breath-actuated vibrating mesh nebulizer and Continuous vibrating mesh nebulizer in people with Healthy Volunteers and Aerosol Therapy, run by Chang Gung University at 1 site in Taiwan.
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 3 inclusion and 16 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Urinary salbutamol concentration (time frame: Urine samples will be collected at 30 minutes before nebulization, at 30 minutes, and 24 hours after nebulization.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06157515, which also lists 21 linked publications.
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 19 Sep 2024.