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Comparison of Lung Deposition With the Aeroneb Solo Adapter and a Standard Jet Nebulizer by SPECT-CT

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02298101
Enrollment
6
Registered
2014-11-21
Start date
2014-09-30
Completion date
Unknown
Last updated
2015-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Aerosol delivery, Lung deposition, SPECT, subjects

Brief 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. We hypothetized that lung deposition could be highly increased with the Aeroneb Solo Adapter in comparison to a standard jet nebulizer.

Interventions

Solution placed on the nebulizer reservoir

DEVICEAeroneb Solo Adapter

Nebulizer

DEVICEOpti-Mist Plus Nebulizer

Standard jet nebulizer

Imaging technique to investigate whole lung deposition

OTHERSingle photon emission computed tomography

Imaging technique to investigate regional pulmonary deposition

OTHERSpirometry

FEV1, FVC assessment

Sponsors

Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
18 Years to 90 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy respiratory function

Exclusion criteria

* Pulmonary disease

Design outcomes

Primary

MeasureTime frameDescription
Pulmonary depositionimmediately after nebulization by imaging assessment, an expected average of 15 minutesPlanar scintigraphy and single photon emission computed tomography as imaging techiques

Secondary

MeasureTime frameDescription
Three-dimensional penetration indeximmediately after the nebulization by imaging assessment, expected average of 30 minutesSingle photon emission computed tomography as imaging technique

Other

MeasureTime frame
SpirometryBaseline

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026