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

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ClinicalTrials.gov Identifier: NCT01428323
Recruitment Status : Unknown
Verified September 2011 by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
Recruitment status was:  Recruiting
First Posted : September 2, 2011
Last Update Posted : September 2, 2011
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Aerosol Drug Therapy Device: Vented and Unvented Jet Nebulizer

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Study Start Date : January 2011
Estimated Primary Completion Date : September 2011
Estimated Study Completion Date : September 2011
Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. Amikacin Urinatory excretion [ Time Frame: Each miction during 24 hours ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT01428323     History of Changes
Other Study ID Numbers: 3.4529.10
First Posted: September 2, 2011    Key Record Dates
Last Update Posted: September 2, 2011
Last Verified: September 2011