NCT02298101

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 21, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Last Updated

November 17, 2015

Status Verified

November 1, 2015

Enrollment Period

9 months

First QC Date

November 19, 2014

Last Update Submit

November 16, 2015

Conditions

Healthy

Keywords

Aerosol deliveryLung depositionSPECTsubjects

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Three-dimensional penetration index

    immediately after the nebulization by imaging assessment, expected average of 30 minutes

Other Outcomes (1)

  • Spirometry

    Baseline

Study Arms (2)

Aeroneb Solo Adapter

ACTIVE COMPARATOR

Subjects inhaled radiolabelled aerosol via the Aeroneb Solo Adapter

Drug: Technetium-99m - Diethylenetriaminepentaacetic acidDevice: Aeroneb Solo AdapterOther: Planar scintigraphyOther: Single photon emission computed tomographyOther: Spirometry

Standard Jet Nebulizer

ACTIVE COMPARATOR

Subjects inhaled radiolabelled aerosol via a standard jet nebulizer, the Opti-Mist Plus Nebulizer

Drug: Technetium-99m - Diethylenetriaminepentaacetic acidDevice: Opti-Mist Plus NebulizerOther: Planar scintigraphyOther: Single photon emission computed tomographyOther: Spirometry

Interventions

Technetium-99m - Diethylenetriaminepentaacetic acidDRUG

Solution placed on the nebulizer reservoir

Aeroneb Solo AdapterStandard Jet Nebulizer
Aeroneb Solo AdapterDEVICE

Nebulizer

Aeroneb Solo Adapter
Opti-Mist Plus NebulizerDEVICE

Standard jet nebulizer

Standard Jet Nebulizer
Planar scintigraphyOTHER

Imaging technique to investigate whole lung deposition

Aeroneb Solo AdapterStandard Jet Nebulizer
Single photon emission computed tomographyOTHER

Imaging technique to investigate regional pulmonary deposition

Aeroneb Solo AdapterStandard Jet Nebulizer
SpirometryOTHER

FEV1, FVC assessment

Aeroneb Solo AdapterStandard Jet Nebulizer

Eligibility Criteria

Age18 Years - 90 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy respiratory function

You may not qualify if:

  • Pulmonary disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Related Publications (1)

  • Dugernier J, Hesse M, Vanbever R, Depoortere V, Roeseler J, Michotte JB, Laterre PF, Jamar F, Reychler G. SPECT-CT Comparison of Lung Deposition using a System combining a Vibrating-mesh Nebulizer with a Valved Holding Chamber and a Conventional Jet Nebulizer: a Randomized Cross-over Study. Pharm Res. 2017 Feb;34(2):290-300. doi: 10.1007/s11095-016-2061-7. Epub 2016 Nov 7.

    PMID: 27822851DERIVED

MeSH Terms

Interventions

Nebulizers and Vaporizers

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2014

First Posted

November 21, 2014

Study Start

September 1, 2014

Primary Completion

June 1, 2015

Last Updated

November 17, 2015

Record last verified: 2015-11

Locations

BE(1)