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

Not Applicable

• Conditions: Aerosol Drug Therapy

• Registration Number: NCT01428323
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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 available

Study Timeline

• Study Start: 2011-01
• Status Verified: 2011-09
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Study First Submitted: 2011-09-01
• Study First Submitted QC: 2011-09-01
• Last Update Submitted: 2011-09-01
• Study First Posted: 2011-09-02
• Last Update Posted: 2011-09-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 7

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Amikacin Urinatory excretion	Each miction during 24 hours

Trial Locations

Locations (1)

Cliniques Universitaires Saint-Luc; 🇧🇪 Bruxelles, Belgium