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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