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OpenTrials
Completed

NCT Number: NCT02298101

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

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.

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Key information

Conditions

Healthy

Age range

18 year–90 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy respiratory function

Exclusion criteria

  • Pulmonary disease

Treatment and study plan

Technetium-99m - Diethylenetriaminepentaacetic acid

Drug

Solution placed on the nebulizer reservoir

Aeroneb Solo Adapter

Device

Nebulizer

Opti-Mist Plus Nebulizer

Device

Standard jet nebulizer

Planar scintigraphy

Other

Imaging technique to investigate whole lung deposition

Single Photon Emission Computed Tomography

Other

Imaging technique to investigate regional pulmonary deposition

Spirometry

Other

FEV1, FVC assessment

Primary outcomes

  1. 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 outcomes

  1. 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

Other outcomes

  1. Spirometry

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
First posted
Nov 21, 2014
Registry last updated
Nov 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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