Healthy VolunteersNCT02501655
Analysis of Deposition With Nebulizers Membrane
A study testing phase 1 - jet nebulizer and Phase 2- mesh nebulizer in people with Healthy Volunteers, run by Daniella Cunha Brandao at 1 site in Brazil.
Trial summary
BACKGROUND: Mesh nebulizers (MN) have lower residual volume and increased inhaled dose compared to jet nebulizers (JN) per in vitro and animal models. The aim of this study was to compare radioaerosol deposition using MN and JN in healthy subjects, using 2-D planar scintigraphy. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- phase 1 - jet nebulizer and Phase 2- mesh nebulizer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2015to Aug 2015
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The study inclusion critera was healthy adults of both sexes, between 18 to 65 years, without history of lung disease or smoking, with forced vital capacity (FVC) or forced expiratory volume in the first second (FEV1) greater or equal to 80% of predicted values (Pereira et al., 1992), ability to follow and retain verbal commands while able and willing to provide signed consent to participate in this study.
Who cannot join
- Participants were excluded if they have been diagnosed with a lung disease, current smoker, unable to understand and follow the procedures and pregnant or unable to tolerate nebulization.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital das Clínicas de Pernambuco
Recife, Pernambuco, 50670-901
Luciana Alcoforado, alcoforadoluciana@gmail.com
About this study
Official title: ANALYSIS OF DEPOSITION RADIOAEROSOL NEBULIZERS MEMBRANE IN HEALTHY SUBJECTS
BACKGROUND: Mesh nebulizers (MN) have lower residual volume and increased inhaled dose compared to jet nebulizers (JN) per in vitro and animal models. The aim of this study was to compare radioaerosol deposition using MN and JN in healthy subjects, using 2-D planar scintigraphy. METHODS: A randomized trial in 6 normal subjects (4 female, 2 male) inhaled 99mTc-DTPA with an activity of 1 mCi with the normal saline to a total dose of 4 mL with JN (Misty Max, Air Life, Yorba Linda, USA) oxygen flow of 8 L / min and 1.5 mL with MN (Aeroneb Solo with Ultra adapter; Aerogen Galway, Ireland). Scintigraphy was used to determine distribution of deposition and mass balance between compartments.
- Conditions
- Healthy Volunteers
- Being tested
- phase 1 - jet nebulizer, Phase 2- mesh nebulizer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phase 1 - jet nebulizerDevice
Aerosol generators diethilene penta-acetic triamine technetium (99mTc-DTPA) with radioactivity of 1 millicuries (Noble et al., 2007) mixed with 0.9% saline solution with a total volume of 4 ml using jet nebulizer (NS - mark) and 8l/min of the oxygen
Phase 2- mesh nebulizerDevice
Aerosol generators diethilene penta-acetic triamine technetium (99mTc-DTPA) with radioactivity of 1 millicuries (Noble et al., 2007) mixed with 0.9% saline solution with a total volume of 2 ml using vibrating mesh inhaler with valved chamber adapter (Aerogen Solo with Ultra Adapter, Aerogen Ltd).
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 | Active comparator | Jet Nebulizer - control group Receives: Device: Phase 2- mesh nebulizer |
| Phase 2 | Experimental | Mesh nebulizers Receives: Device: phase 1 - jet nebulizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
radioaerosol deposition index into the lungs
Immediately after inhalation, participants sat in a chair with the back positioned in front to the gamma camera (STARCAM 3200 GE, California, USA) to obtain radioactivity counts from the posterior thorax during a period of 300 seconds on a matrix of 256 X 256. After, participants were positioned sitting in front to the gama camera to obtain images from face. Then, the same procedure was performed to analysis deposition in the nebulizer, circuits, inspiratory filter, expiratory filter and face mask. Counts representing stomach were obtained from posterior thorax and corrections for decay of technetium were used to during extrapulmonary measurements
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionAug 2015 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daniella Cunha Brandao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Daniella Cunha Brandao, Universidade Federal de Pernambuco
- Investigators
- Luciana Alcoforado, Principal investigator, UFPE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02501655
- Sponsor's protocol ID
- Luciana doutorado 01
- Status last verified
- Jul 2015
- First submitted
- 15 Jul 2015
- Last updated
- 17 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ANALYSIS OF DEPOSITION RADIOAEROSOL NEBULIZERS MEMBRANE IN HEALTHY SUBJECTS
- ClinicalTrials.gov ID
- NCT02501655
- Acronym / sponsor ID
- Luciana doutorado 01
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Daniella Cunha BrandaoUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 17 Jul 2015 (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: Mesh nebulizers (MN) have lower residual volume and increased inhaled dose compared to jet nebulizers (JN) per in vitro and animal models. The aim of this study was to compare radioaerosol deposition using MN and JN in healthy subjects, using 2-D planar scintigraphy. METHODS: A randomized trial in 6 normal subjects (4 female, 2 male) inhaled 99mTc-DTPA with an activity of 1 mCi with the normal saline to a total dose of 4 mL with JN (Misty Max, Air Life, Yorba Linda, USA) oxygen flow of 8 L / min and 1.5 mL with MN (Aeroneb Solo with Ultra adapter; Aerogen Galway, Ireland). Scintigraphy was used to determine distribution of deposition and mass balance between compartments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1 | Active comparator | Device: Phase 2- mesh nebulizerJet Nebulizer - control group |
| Phase 2 | Experimental | Device: phase 1 - jet nebulizerMesh nebulizers |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The study inclusion critera was healthy adults of both sexes, between 18 to 65 years, without history of lung disease or smoking, with forced vital capacity (FVC) or forced expiratory volume in the first second (FEV1) greater or equal to 80% of predicted values (Pereira et al., 1992), ability to follow and retain verbal commands while able and willing to provide signed consent to participate in this study.
Key exclusion criteria (1 listed)
- Participants were excluded if they have been diagnosed with a lung disease, current smoker, unable to understand and follow the procedures and pregnant or unable to tolerate nebulization.
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 |
|---|---|---|
| phase 1 - jet nebulizerAerosol generators diethilene penta-acetic triamine technetium (99mTc-DTPA) with radioactivity of 1 millicuries (Noble et al., 2007) mixed with 0.9% saline solution with a total volume of 4 ml using jet nebulizer (NS - mark) and 8l/min of the oxygen | Device | Phase 2 |
| Phase 2- mesh nebulizerAerosol generators diethilene penta-acetic triamine technetium (99mTc-DTPA) with radioactivity of 1 millicuries (Noble et al., 2007) mixed with 0.9% saline solution with a total volume of 2 ml using vibrating mesh inhaler with valved chamber adapter (Aerogen Solo with Ultra Adapter, Aerogen Ltd). | Device | Phase 1 |
Primary outcome
radioaerosol deposition index into the lungs
Time frame: 1 month
Immediately after inhalation, participants sat in a chair with the back positioned in front to the gamma camera (STARCAM 3200 GE, California, USA) to obtain radioactivity counts from the posterior thorax during a period of 300 seconds on a matrix of 256 X 256. After, participants were positioned sitting in front to the gama camera to obtain images from face. Then, the same procedure was performed to analysis deposition in the nebulizer, circuits, inspiratory filter, expiratory filter and face mask. Counts representing stomach were obtained from posterior thorax and corrections for decay of technetium were used to during extrapulmonary measurements
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2015.
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Screening Protocol
Pain
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.
Luciana Alcoforado principal investigator
UFPE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing phase 1 - jet nebulizer and Phase 2- mesh nebulizer in people with Healthy Volunteers, run by Daniella Cunha Brandao at 1 site in Brazil.
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 1 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: status not confirmed, as of the sponsor's last update on 17 Jul 2015. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
radioaerosol deposition index into the lungs (time frame: 1 month). 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 17 Jul 2015.