- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01428323
Study of the Aerosol Deposition With Vented and Unvented Jet Nebulizer in Healthy Subjets
September 1, 2011 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
7
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Laurent NP Pitance, PT
- Phone Number: +3227645711
- Email: laurent.pitance@uclouvain.be
Study Contact Backup
- Name: Giusepe Liistro, MD
- Phone Number: +3227642843
- Email: Giusepe.liistro@uclouvain.be
Study Locations
-
-
-
Bruxelles, Belgium, 1200
- Recruiting
- Cliniques Universitaires Saint-Luc
-
Contact:
- Laurent Pitance, PT
- Phone Number: +3227645702
- Email: laurent.pitance@uclouvain.be
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Amikacin Urinatory excretion
Time Frame: Each miction during 24 hours
|
Each miction during 24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (Anticipated)
September 1, 2011
Study Completion (Anticipated)
September 1, 2011
Study Registration Dates
First Submitted
September 1, 2011
First Submitted That Met QC Criteria
September 1, 2011
First Posted (Estimate)
September 2, 2011
Study Record Updates
Last Update Posted (Estimate)
September 2, 2011
Last Update Submitted That Met QC Criteria
September 1, 2011
Last Verified
September 1, 2011
More Information
Terms related to this study
Other Study ID Numbers
- 3.4529.10
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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