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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
Recruitment status was  Recruiting
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 23, 2014