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NCT01428323 Clinical Trial

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

Aerosol Drug Therapy Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01428323
Other study ID # 3.4529.10
Secondary ID
Status Recruiting
Phase N/A
First received September 1, 2011
Last updated September 1, 2011
Start date January 2011
Est. completion date September 2011

Study information
Verified date September 2011
Source Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Contact Laurent NP Pitance, PT
Phone +3227645711
Email laurent.pitance@uclouvain.be
Is FDA regulated No
Health authority Belgium: Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 7
Est. completion date September 2011
Est. primary completion date September 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 60 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Device:
• Vented and Unvented Jet Nebulizer
Nebulizers used with 500mg aminoglycosides in 4ml until One minute after the sputerring point.

Locations
Country Name City State
Belgium Cliniques Universitaires Saint-Luc Bruxelles

Sponsors (2)
Lead Sponsor Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain Fonds National de la Recherche Scientifique

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Amikacin Urinatory excretion Each miction during 24 hours No