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

Healthy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02298101
• Other study ID #: AeroSpect-01
• Status: Completed
• Phase: N/A
• First received: November 19, 2014
• Last updated: November 16, 2015
• Start date: September 2014

Study information

• Verified date: November 2015
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Healthy respiratory function

Exclusion Criteria:

• Pulmonary disease

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Technetium-99m - Diethylenetriaminepentaacetic acid
Solution placed on the nebulizer reservoir

Device:
• Aeroneb Solo Adapter
Nebulizer
• Opti-Mist Plus Nebulizer
Standard jet nebulizer

Other:
• Planar scintigraphy
Imaging technique to investigate whole lung deposition
• Single photon emission computed tomography
Imaging technique to investigate regional pulmonary deposition
• Spirometry
FEV1, FVC assessment

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint-Luc	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Spirometry		Baseline	No
Primary	Pulmonary deposition	Planar scintigraphy and single photon emission computed tomography as imaging techiques	immediately after nebulization by imaging assessment, an expected average of 15 minutes	No
Secondary	Three-dimensional penetration index	Single photon emission computed tomography as imaging technique	immediately after the nebulization by imaging assessment, expected average of 30 minutes	No