HealthyNCT02298101
Comparison of Lung Deposition With the Aeroneb Solo Adapter and a Standard Jet Nebulizer by SPECT-CT
A study testing Technetium-99m - Diethylenetriaminepentaacetic acid, Aeroneb Solo Adapter and Opti-Mist Plus Nebulizer in people with Healthy, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
Aeroneb Solo Adapter is a vibrating-mesh nebulizer Aeroneb Solo combined to a spacer specifically designed for spontaneously breathing patients. This device has not been investigated in vivo yet. It's known that using a spacer during nebulization improves aerosol delivery. Read more about this study
- Who is it for?
- Ages 18 to 90 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Technetium-99m - Diethylenetriaminepentaacetic acid, Aeroneb Solo Adapter and Opti-Mist Plus Nebulizer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2014to Jun 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 90 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy respiratory function
Who cannot join
- Pulmonary disease
Trial locations and contacts
1 site in 1 country.
About this study
Aeroneb Solo Adapter is a vibrating-mesh nebulizer Aeroneb Solo combined to a spacer specifically designed for spontaneously breathing patients. This device has not been investigated in vivo yet.
It's known that using a spacer during nebulization improves aerosol delivery. We hypothetized that lung deposition could be highly increased with the Aeroneb Solo Adapter in comparison to a standard jet nebulizer.
- Conditions
- Healthy
- Being tested
- Technetium-99m - Diethylenetriaminepentaacetic acid, Aeroneb Solo Adapter, Opti-Mist Plus Nebulizer, Planar scintigraphy, Single photon emission computed tomography
- Keywords
- Aerosol delivery, Lung deposition, SPECT, subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technetium-99m - Diethylenetriaminepentaacetic acidDrug
Solution placed on the nebulizer reservoir
Aeroneb Solo AdapterDevice
Nebulizer
Opti-Mist Plus NebulizerDevice
Standard jet nebulizer
Planar scintigraphyOther
Imaging technique to investigate whole lung deposition
Single photon emission computed tomographyOther
Imaging technique to investigate regional pulmonary deposition
SpirometryOther
FEV1, FVC assessment
| Study group | Role | What they receive |
|---|---|---|
| Aeroneb Solo Adapter | Active comparator | Subjects inhaled radiolabelled aerosol via the Aeroneb Solo Adapter Receives: Drug: Technetium-99m - Diethylenetriaminepentaacetic acid; Device: Aeroneb Solo Adapter; Other: Planar scintigraphy; Other: Single photon emission computed tomography; Other: Spirometry |
| Standard Jet Nebulizer | Active comparator | Subjects inhaled radiolabelled aerosol via a standard jet nebulizer, the Opti-Mist Plus Nebulizer Receives: Drug: Technetium-99m - Diethylenetriaminepentaacetic acid; Device: Opti-Mist Plus Nebulizer; Other: Planar scintigraphy; Other: Single photon emission computed tomography; Other: Spirometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary deposition
Planar scintigraphy and single photon emission computed tomography as imaging techiques
Measured: immediately after nebulization by imaging assessment, an expected average of 15 minutes
Secondary outcomes (1)
Three-dimensional penetration index
Single photon emission computed tomography as imaging technique
Measured: immediately after the nebulization by imaging assessment, expected average of 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2014 (estimated)
- Study startSep 2014
- Primary completionJun 2015
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.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02298101
- Sponsor's protocol ID
- AeroSpect-01
- Status last verified
- Nov 2015
- First submitted
- 19 Nov 2014
- Last updated
- 17 Nov 2015
- Results posted
- No
Publications
Dugernier J, Hesse M, Vanbever R, Depoortere V, Roeseler J, Michotte JB, Laterre PF, Jamar F, Reychler G. SPECT-CT Comparison of Lung Deposition using a System combining a Vibrating-mesh Nebulizer with a Valved Holding Chamber and a Conventional Jet Nebulizer: a Randomized Cross-over Study. Pharm Res. 2017 Feb;34(2):290-300. doi: 10.1007/s11095-016-2061-7. Epub 2016 Nov 7.
PubMed 27822851
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Lung Deposition With the Aeroneb Solo Adapter and a Standard Jet Nebulizer by SPECT-CT
- ClinicalTrials.gov ID
- NCT02298101
- Acronym / sponsor ID
- AeroSpect-01
- Conditions
- Healthy
- Keywords
- Aerosol delivery, Lung deposition, SPECT, subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jun 2015 (actual)
- First posted
- 21 Nov 2014 (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.
Aeroneb Solo Adapter is a vibrating-mesh nebulizer Aeroneb Solo combined to a spacer specifically designed for spontaneously breathing patients. This device has not been investigated in vivo yet.
It's known that using a spacer during nebulization improves aerosol delivery. We hypothetized that lung deposition could be highly increased with the Aeroneb Solo Adapter in comparison to a standard jet nebulizer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aeroneb Solo Adapter | Active comparator | Drug: Technetium-99m - Diethylenetriaminepentaacetic acid, Device: Aeroneb Solo Adapter, Other: Planar scintigraphy, Other: Single photon emission computed tomography, Other: SpirometrySubjects inhaled radiolabelled aerosol via the Aeroneb Solo Adapter |
| Standard Jet Nebulizer | Active comparator | Drug: Technetium-99m - Diethylenetriaminepentaacetic acid, Device: Opti-Mist Plus Nebulizer, Other: Planar scintigraphy, Other: Single photon emission computed tomography, Other: SpirometrySubjects inhaled radiolabelled aerosol via a standard jet nebulizer, the Opti-Mist Plus Nebulizer |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy respiratory function
Key exclusion criteria (1 listed)
- Pulmonary 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 |
|---|---|---|
| Technetium-99m - Diethylenetriaminepentaacetic acidSolution placed on the nebulizer reservoir | Drug | Aeroneb Solo Adapter, Standard Jet Nebulizer |
| Aeroneb Solo AdapterNebulizer | Device | Aeroneb Solo Adapter |
| Opti-Mist Plus NebulizerStandard jet nebulizer | Device | Standard Jet Nebulizer |
| Planar scintigraphyImaging technique to investigate whole lung deposition | Other | Aeroneb Solo Adapter, Standard Jet Nebulizer |
| Single photon emission computed tomographyImaging technique to investigate regional pulmonary deposition | Other | Aeroneb Solo Adapter, Standard Jet Nebulizer |
| SpirometryFEV1, FVC assessment | Other | Aeroneb Solo Adapter, Standard Jet Nebulizer |
Primary outcome
Pulmonary deposition
Time frame: immediately after nebulization by imaging assessment, an expected average of 15 minutes
Planar scintigraphy and single photon emission computed tomography as imaging techiques
1 secondary outcome
Three-dimensional penetration index
Time frame: immediately after the nebulization by imaging assessment, expected average of 30 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 17 Nov 2015.
- Derived from this study: PubMed 27822851Dugernier J, Hesse M, Vanbever R, Depoortere V, Roeseler J, Michotte JB, Laterre PF, Jamar F, Reychler G. SPECT-CT Comparison of Lung Deposition using a System combining a Vibrating-mesh Nebulizer with a Valved Holding Chamber and a Conventional Jet Nebulizer: a Randomized Cross-over Study. Pharm Res. 2017 Feb;34(2):290-300. doi: 10.1007/s11095-016-2061-7. Epub 2016 Nov 7.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technetium-99m - Diethylenetriaminepentaacetic acid, Aeroneb Solo Adapter and Opti-Mist Plus Nebulizer in people with Healthy, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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: finished, as of the sponsor's last update on 17 Nov 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 Belgium. 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?
Pulmonary deposition (time frame: immediately after nebulization by imaging assessment, an expected average of 15 minutes). 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 NCT02298101, 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 17 Nov 2015.