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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Drug: Technetium-99m - Diethylenetriaminepentaacetic acid; Device: Opti-Mist Plus Nebulizer; Device: Aeroneb Solo Adapter; Other: Planar scintigraphy; Other: Single photon emission computed tomography; Other: Spirometry

• Registration Number: NCT02298101
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-11-19
• Study First Submitted QC: 2014-11-20
• Study First Posted: 2014-11-21
• Primary Completion: 2015-06
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-16
• Last Update Posted: 2015-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

Inclusion Criteria

• Healthy respiratory function

Exclusion Criteria

• Pulmonary disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Aeroneb Solo Adapter	Technetium-99m - Diethylenetriaminepentaacetic acid	Subjects inhaled radiolabelled aerosol via the Aeroneb Solo Adapter
Standard Jet Nebulizer	Opti-Mist Plus Nebulizer	Subjects inhaled radiolabelled aerosol via a standard jet nebulizer, the Opti-Mist Plus Nebulizer
Aeroneb Solo Adapter	Aeroneb Solo Adapter	Subjects inhaled radiolabelled aerosol via the Aeroneb Solo Adapter
Aeroneb Solo Adapter	Spirometry	Subjects inhaled radiolabelled aerosol via the Aeroneb Solo Adapter
Aeroneb Solo Adapter	Planar scintigraphy	Subjects inhaled radiolabelled aerosol via the Aeroneb Solo Adapter
Aeroneb Solo Adapter	Single photon emission computed tomography	Subjects inhaled radiolabelled aerosol via the Aeroneb Solo Adapter
Standard Jet Nebulizer	Planar scintigraphy	Subjects inhaled radiolabelled aerosol via a standard jet nebulizer, the Opti-Mist Plus Nebulizer
Standard Jet Nebulizer	Single photon emission computed tomography	Subjects inhaled radiolabelled aerosol via a standard jet nebulizer, the Opti-Mist Plus Nebulizer
Standard Jet Nebulizer	Spirometry	Subjects inhaled radiolabelled aerosol via a standard jet nebulizer, the Opti-Mist Plus Nebulizer
Standard Jet Nebulizer	Technetium-99m - Diethylenetriaminepentaacetic acid	Subjects inhaled radiolabelled aerosol via a standard jet nebulizer, the Opti-Mist Plus Nebulizer

Primary Outcome Measures

Name	Time	Method
Pulmonary deposition	immediately after nebulization by imaging assessment, an expected average of 15 minutes	Planar scintigraphy and single photon emission computed tomography as imaging techiques

Secondary Outcome Measures

Name	Time	Method
Three-dimensional penetration index	immediately after the nebulization by imaging assessment, expected average of 30 minutes	Single photon emission computed tomography as imaging technique

Trial Locations

Locations (1)

Cliniques Universitaires Saint-Luc; 🇧🇪 Brussels, Belgium