Comparison of Lung Deposition With the Aeroneb Solo Adapter and a Standard Jet Nebulizer by SPECT-CT
Overview
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 Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Primary Purpose: Treatment
- Masking: Double (Investigator, Outcomes Assessor)
- Study Primary Completion Date: June 2015
Interventions
- Drug: Technetium-99m – Diethylenetriaminepentaacetic acid
- Solution placed on the nebulizer reservoir
- Device: Aeroneb Solo Adapter
- Nebulizer
- Device: Opti-Mist Plus Nebulizer
- Standard jet nebulizer
- Other: Planar scintigraphy
- Imaging technique to investigate whole lung deposition
- Other: Single photon emission computed tomography
- Imaging technique to investigate regional pulmonary deposition
- Other: Spirometry
- FEV1, FVC assessment
Arms, Groups and Cohorts
- Active Comparator: Aeroneb Solo Adapter
- Subjects inhaled radiolabelled aerosol via the Aeroneb Solo Adapter
- Active Comparator: Standard Jet Nebulizer
- Subjects inhaled radiolabelled aerosol via a standard jet nebulizer, the Opti-Mist Plus Nebulizer
Clinical Trial Outcome Measures
Primary Measures
- 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
Secondary Measures
- Three-dimensional penetration index
- Time Frame: immediately after the nebulization by imaging assessment, expected average of 30 minutes
- Single photon emission computed tomography as imaging technique
Participating in This Clinical Trial
Inclusion Criteria
- Healthy respiratory function Exclusion Criteria:
- Pulmonary disease
Gender Eligibility: Male
Minimum Age: 18 Years
Maximum Age: 90 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Provider of Information About this Clinical Study
- Sponsor
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