Comparison of Amikacin Lung Delivery With Two Nebulizers

September 1, 2015 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Comparison between two modalities of nebulization.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

12

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 Locations

  • Belgium
      • Brussels, Belgium, 1200
        • Recruiting
        • Cliniques Universitaires Saint-Luc
        • Contact:
        • Principal Investigator:
          • Anne-Sophie Aubriot, PT

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

16 years to 55 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male healthy subjects
  • Cystic fibrosis

Exclusion Criteria:

  • Kidney failure
  • No pregnancy

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nebulizer 1
Nebulization with akita nebulizer
Device: Nebulizer 1
Other Names:
  • Akita
Active Comparator: Nebulizer 2
Nebulization with eFlow nebulizer
Device: Nebulizer 2
Other Names:
  • eFlow

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total urinary concentration of amikacin
Time Frame: 24 hours after the nebulization
Pharmacokinetic study of the urinary excretion of amikacin after nebulization
24 hours after the nebulization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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

August 1, 2015

Primary Completion (Anticipated)

September 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

August 24, 2015

First Submitted That Met QC Criteria

September 1, 2015

First Posted (Estimate)

September 2, 2015

Study Record Updates

Last Update Posted (Estimate)

September 2, 2015

Last Update Submitted That Met QC Criteria

September 1, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Akeflow

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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