Study of the Aerosol Deposition With Vented and Unvented Jet Nebulizer in Healthy Subjets

NCT ID: NCT01428323

Last Updated: 2011-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-09-30

Brief Summary

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Open-vent jet nebulizers are frequently used to promote drug lung deposition but their clinical efficacy and indications are not clear.

Our study aimed to compare inhaled mass, and lung deposition of amikacin by using a jet nebulizer (Sidestream) under two different configurations: vented and unvented coupled to a 110 ml corrugated piece of tubing.

Detailed Description

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Conditions

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Aerosol Drug Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Interventions

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Vented and Unvented Jet Nebulizer

Nebulizers used with 500mg aminoglycosides in 4ml until One minute after the sputerring point.

Intervention Type DEVICE

Other Intervention Names

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Nebulizer Type: Sidestream

Eligibility Criteria

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Inclusion Criteria

* Healthy Volunteers between 18 and 60 years old

Exclusion Criteria

* Smokers
* Pathological spirometry
* History of treatment with aminoglygosides 1 month prior the study
* Known allergy to aminoglycosydes
* Any lung pathology or history of lung surgery
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Fonds National de la Recherche Scientifique

OTHER

Sponsor Role collaborator

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cliniques Universitaires Saint-Luc

Brussels, Brussels Capital, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Laurent NP Pitance, PT

Role: CONTACT

+3227645711

Giusepe Liistro, MD

Role: CONTACT

+3227642843

Facility Contacts

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Laurent Pitance, PT

Role: primary

+3227645702

Other Identifiers

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3.4529.10

Identifier Type: -

Identifier Source: org_study_id

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