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

November 16, 2015 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • Cliniques Universitaires Saint-luc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy respiratory function

Exclusion Criteria:

  • Pulmonary disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: immediately after the nebulization by imaging assessment, expected average of 30 minutes
Single photon emission computed tomography as imaging technique
immediately after the nebulization by imaging assessment, expected average of 30 minutes

Other Outcome Measures

Outcome Measure
Time Frame
Spirometry
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

November 19, 2014

First Submitted That Met QC Criteria

November 20, 2014

First Posted (Estimate)

November 21, 2014

Study Record Updates

Last Update Posted (Estimate)

November 17, 2015

Last Update Submitted That Met QC Criteria

November 16, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AeroSpect-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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