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

Study Overview
=================
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.

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Technetium-99m - Diethylenetriaminepentaacetic acid
* Device: Aeroneb Solo Adapter
* Device: Opti-Mist Plus Nebulizer
* Other: Planar scintigraphy
* Other: Single photon emission computed tomography
* Other: Spirometry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy respiratory function Exclusion Criteria: Pulmonary disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Aeroneb Solo Adapter<br>Subjects inhaled radiolabelled aerosol via the Aeroneb Solo Adapter | Drug: Technetium-99m - Diethylenetriaminepentaacetic acid<br>* Solution placed on the nebulizer reservoir<br>Device: Aeroneb Solo Adapter<br>* Nebulizer<br>Other: Planar scintigraphy<br>* Imaging technique to investigate whole lung deposition<br>Other: Single photon emission computed tomography<br>* Imaging technique to investigate regional pulmonary deposition<br>Other: Spirometry<br>* FEV1, FVC assessment<br>|
| Active Comparator: Standard Jet Nebulizer<br>Subjects inhaled radiolabelled aerosol via a standard jet nebulizer, the Opti-Mist Plus Nebulizer | Drug: Technetium-99m - Diethylenetriaminepentaacetic acid<br>* Solution placed on the nebulizer reservoir<br>Device: Opti-Mist Plus Nebulizer<br>* Standard jet nebulizer<br>Other: Planar scintigraphy<br>* Imaging technique to investigate whole lung deposition<br>Other: Single photon emission computed tomography<br>* Imaging technique to investigate regional pulmonary deposition<br>Other: Spirometry<br>* FEV1, FVC assessment<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Three-dimensional penetration index | Single photon emission computed tomography as imaging technique | immediately after the nebulization by imaging assessment, expected average of 30 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aerosol delivery, Lung deposition, SPECT, subjects