Study of the Aerosol Deposition With Vented and Unvented Jet Nebulizer in Healthy Subjets
This study is currently recruiting participants.
Verified September 2011 by Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Collaborator:
Fonds National de la Recherche Scientifique
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT01428323
First received: September 1, 2011
Last updated: NA
Last verified: September 2011
History: No changes posted
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Aerosol Drug Therapy |
Device: Vented and Unvented Jet Nebulizer |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label |
Further study details as provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
Primary Outcome Measures:
- Amikacin Urinatory excretion [ Time Frame: Each miction during 24 hours ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 7 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | September 2011 |
| Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Device: Vented and Unvented Jet Nebulizer
Nebulizers used with 500mg aminoglycosides in 4ml until One minute after the sputerring point.
Other Name: Nebulizer Type: Sidestream
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01428323
Contacts
| Contact: Laurent NP Pitance, PT | +3227645711 | laurent.pitance@uclouvain.be |
| Contact: Giusepe Liistro, MD | +3227642843 | Giusepe.liistro@uclouvain.be |
Locations
| Belgium | |
| Cliniques Universitaires Saint-Luc | Recruiting |
| Bruxelles, Belgium, 1200 | |
| Contact: Laurent Pitance, PT +3227645702 laurent.pitance@uclouvain.be | |
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Fonds National de la Recherche Scientifique
More Information
No publications provided
| Responsible Party: | Cliniques universitaires Saint-Luc- Université Catholique de Louvain |
| ClinicalTrials.gov Identifier: | NCT01428323 History of Changes |
| Other Study ID Numbers: | 3.4529.10 |
| Study First Received: | September 1, 2011 |
| Last Updated: | September 1, 2011 |
| Health Authority: | Belgium: Ethics Committee |
ClinicalTrials.gov processed this record on May 21, 2013