HealthyNCT02519465
Evaluation of Lung Deposition of Aerosol Via HFNC in Healthy Adults
A study testing 10l/min, 30l/min and 50l/min in people with Healthy, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial summary
The aerosol associated with noninvasive ventilation (NIV) and high flow therapy with nasal interface have been employed in an attempt to relieve respiratory distress and optimize the deposition of drugs by inhalation. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 10l/min, 30l/min and 50l/min
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 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 included healthy individuals of both sexes,
- between 18 to 65 years,
- without history of lung disease and forced vital capacity (FVC) or forced expiratory volume in the first second (FEV1) higher or equal to 80% from predicted values,
- ability to verbal commands understand and
- willing to provide signed consent to participate in this study.
Who cannot join
- Participants were excluded if there unable to understand and follow the procedures and were pregnant and unable to tolerate nebulization.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Laboratório de Fisiologia e Fisioterapia Cardiopulmonar
Recife, Pernambuco
Luciana Alcoforado, lucalcoforado@yahoo.com.br
About this study
The aerosol associated with noninvasive ventilation (NIV) and high flow therapy with nasal interface have been employed in an attempt to relieve respiratory distress and optimize the deposition of drugs by inhalation.
Some studies report the effects of NIV association with fogging in healthy subjects, asthmatics and COPD 7.8, but studies evaluating the association between high flow nasal mist interface and therapy are scarce and most are found in vitro and animal models. The objective of this study is to evaluate the deposition of the aerosol scintigraphy using the high flow nasal interface system with vibrating mesh nebulizers using in healthy adults.
- Conditions
- Healthy
- Being tested
- 10l/min, 30l/min, 50l/min
- Keywords
- nasal cannula, Inhalation Devices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10l/minOther
For inhalation was used diethilene penta-acetic triamine technetium (99mTc-DTPA) with radioactivity of 1 millicuries (Noble et al., 2007) and 0.9% saline solution with a total volume of 1 ml using vibrating mesh inhaler (Aerogen Ltd, Galway , Ireland) with the respiratory care system for the high flow ( Fisher \& Paykel healthcare, New Zealand) and nasal cannula (Fisher \& Paykel healthcare, New Zealand) with flow 10l/min
30l/minOther
For inhalation was used diethilene penta-acetic triamine technetium (99mTc-DTPA) with radioactivity of 1 millicuries (Noble et al., 2007) and 0.9% saline solution with a total volume of 1 ml using vibrating mesh inhaler (Aerogen Ltd, Galway , Ireland) with the respiratory care system for the high flow ( Fisher \& Paykel healthcare, New Zealand) and nasal cannula (Fisher \& Paykel healthcare, New Zealand) with flow 30l/min.
50l/minOther
For inhalation was used diethilene penta-acetic triamine technetium (99mTc-DTPA) with radioactivity of 1 millicuries (Noble et al., 2007) and 0.9% saline solution with a total volume of 1 ml using vibrating mesh inhaler (Aerogen Ltd, Galway , Ireland) with the respiratory care system for the high flow ( Fisher \& Paykel healthcare, New Zealand) and nasal cannula (Fisher \& Paykel healthcare, New Zealand) with flow 50l/min.
| Study group | Role | What they receive |
|---|---|---|
| HEATED FLOW | Active comparator | The volunteers were randomly allocated into three groups - group 1 - 10l/min cold or heated, group 2 - 30l/min cold or heated, group 3 - 50 l /min - cold or heatedPhase 1 - 10l/min or 30l/min or 50l/min of the oxygen heated . Receives: Other: 10l/min; Other: 30l/min; Other: 50l/min |
| COLD FLOW | Active comparator | The volunteers were randomly allocated into three groups - group 1 - 10l/min cold or heated, group 2 - 30l/min cold or heated, group 3 - 50 l /min - cold or heatedPhase 1 - 10l/min or 30l/min or 50l/min of the oxygen cold Receives: Other: 10l/min; Other: 30l/min; Other: 50l/min |
What is being measured
The primary outcome is the main question the study is designed to answer.
radioaerosol deposition index into the lungs
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 posted11 Aug 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniella Cunha Brandao, Universidade Federal de Pernambuco
- Investigators
- Luciana Alcoforado, MsC, Principal investigator, UFPE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02519465
- Sponsor's protocol ID
- Luciana doutorado 02
- Status last verified
- Aug 2015
- First submitted
- 6 Aug 2015
- Last updated
- 11 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Alcoforado L, Ari A, Barcelar JM, Brandao SCS, Fink JB, de Andrade AD. Impact of Gas Flow and Humidity on Trans-Nasal Aerosol Deposition via Nasal Cannula in Adults: A Randomized Cross-Over Study. Pharmaceutics. 2019 Jul 7;11(7):320. doi: 10.3390/pharmaceutics11070320.
PubMed 31284680
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Lung Deposition of Aerosol Via HFNC in Healthy Adults
- ClinicalTrials.gov ID
- NCT02519465
- Acronym / sponsor ID
- Luciana doutorado 02
- Conditions
- Healthy
- Keywords
- nasal cannula, Inhalation Devices
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 11 Aug 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.
The aerosol associated with noninvasive ventilation (NIV) and high flow therapy with nasal interface have been employed in an attempt to relieve respiratory distress and optimize the deposition of drugs by inhalation.
Some studies report the effects of NIV association with fogging in healthy subjects, asthmatics and COPD 7.8, but studies evaluating the association between high flow nasal mist interface and therapy are scarce and most are found in vitro and animal models. The objective of this study is to evaluate the deposition of the aerosol scintigraphy using the high flow nasal interface system with vibrating mesh nebulizers using in healthy adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HEATED FLOW | Active comparator | Other: 10l/min, Other: 30l/min, Other: 50l/minThe volunteers were randomly allocated into three groups - group 1 - 10l/min cold or heated, group 2 - 30l/min cold or heated, group 3 - 50 l /min - cold or heatedPhase 1 - 10l/min or 30l/min or 50l/min of the oxygen heated . |
| COLD FLOW | Active comparator | Other: 10l/min, Other: 30l/min, Other: 50l/minThe volunteers were randomly allocated into three groups - group 1 - 10l/min cold or heated, group 2 - 30l/min cold or heated, group 3 - 50 l /min - cold or heatedPhase 1 - 10l/min or 30l/min or 50l/min of the oxygen cold |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The study included healthy individuals of both sexes,
- between 18 to 65 years,
- without history of lung disease and forced vital capacity (FVC) or forced expiratory volume in the first second (FEV1) higher or equal to 80% from predicted values,
- ability to verbal commands understand and
- willing to provide signed consent to participate in this study.
Key exclusion criteria (1 listed)
- Participants were excluded if there unable to understand and follow the procedures and were pregnant and 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 |
|---|---|---|
| 10l/minFor inhalation was used diethilene penta-acetic triamine technetium (99mTc-DTPA) with radioactivity of 1 millicuries (Noble et al., 2007) and 0.9% saline solution with a total volume of 1 ml using vibrating mesh inhaler (Aerogen Ltd, Galway , Ireland) with the respiratory care system for the high flow ( Fisher \& Paykel healthcare, New Zealand) and nasal cannula (Fisher \& Paykel healthcare, New Zealand) with flow 10l/min | Other | COLD FLOW, HEATED FLOW |
| 30l/minFor inhalation was used diethilene penta-acetic triamine technetium (99mTc-DTPA) with radioactivity of 1 millicuries (Noble et al., 2007) and 0.9% saline solution with a total volume of 1 ml using vibrating mesh inhaler (Aerogen Ltd, Galway , Ireland) with the respiratory care system for the high flow ( Fisher \& Paykel healthcare, New Zealand) and nasal cannula (Fisher \& Paykel healthcare, New Zealand) with flow 30l/min. | Other | COLD FLOW, HEATED FLOW |
| 50l/minFor inhalation was used diethilene penta-acetic triamine technetium (99mTc-DTPA) with radioactivity of 1 millicuries (Noble et al., 2007) and 0.9% saline solution with a total volume of 1 ml using vibrating mesh inhaler (Aerogen Ltd, Galway , Ireland) with the respiratory care system for the high flow ( Fisher \& Paykel healthcare, New Zealand) and nasal cannula (Fisher \& Paykel healthcare, New Zealand) with flow 50l/min. | Other | COLD FLOW, HEATED FLOW |
Primary outcome
radioaerosol deposition index into the lungs
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2015.
- Derived from this study: PubMed 31284680Alcoforado L, Ari A, Barcelar JM, Brandao SCS, Fink JB, de Andrade AD. Impact of Gas Flow and Humidity on Trans-Nasal Aerosol Deposition via Nasal Cannula in Adults: A Randomized Cross-Over Study. Pharmaceutics. 2019 Jul 7;11(7):320. doi: 10.3390/pharmaceutics11070320.
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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.
Luciana Alcoforado, MsC 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 10l/min, 30l/min and 50l/min in people with Healthy, run by Universidade Federal de Pernambuco 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 5 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 11 Aug 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?
Contact Daniella C Brandao, PhD (+558121268496, daniellacunha@hotmail.com), or a site near the patient. 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?
On the ClinicalTrials.gov record for NCT02519465, which also lists 1 linked publication.
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 11 Aug 2015; AzTrials last refreshed its copy on 8 Nov 2026.