Study of the Aerosol Deposition With Vented and Unvented... | NCT01428323

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

NCT01428323

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status

Unknown status

Last Update Posted

Sep 2, 2011Estimated

Enrollment

7Estimated

Phase

Not Applicable

Conditions

Aerosol Drug Therapy

Interventions

Vented and Unvented Jet Nebulizer

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Sep 2011Estimated

Completion Date

Sep 2011Estimated

First Submitted Date

Sep 1, 2011

First Submission Date that Met QC Criteria

Sep 1, 2011

First Posted Date

Sep 2, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 1, 2011

Last Update Posted Date

Sep 2, 2011Estimated

Name	Class
Fonds National de la Recherche Scientifique	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

7Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vented and Unvented Jet Nebulizer	Device	Nebulizers used with 500mg aminoglycosides in 4ml until One minute after the sputerring point.		Nebulizer Type: Sidestream

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Amikacin Urinatory excretion		Each miction during 24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Laurent NP Pitance, PT	Contact	+3227645711		laurent.pitance@uclouvain.be
Giusepe Liistro, MD	Contact	+3227642843		Giusepe.liistro@uclouvain.be

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cliniques Universitaires Saint-Luc	Recruiting	Brussels	Brussels Capital	1200	Belgium