search
Back to results

Comparison of Amikacin Lung Delivery With Two Nebulizers

Primary Purpose

Healthy, Cystic Fibrosis

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Nebulizer 1
Nebulizer 2
Sponsored by
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy focused on measuring Healthy Volunteers

Eligibility Criteria

16 Years - 55 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Male healthy subjects
  • Cystic fibrosis

Exclusion Criteria:

  • Kidney failure
  • No pregnancy

Sites / Locations

  • Cliniques universitaires Saint-LucRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nebulizer 1

Nebulizer 2

Arm Description

Nebulization with akita nebulizer

Nebulization with eFlow nebulizer

Outcomes

Primary Outcome Measures

Total urinary concentration of amikacin
Pharmacokinetic study of the urinary excretion of amikacin after nebulization

Secondary Outcome Measures

Full Information

First Posted
August 24, 2015
Last Updated
September 1, 2015
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
search

1. Study Identification

Unique Protocol Identification Number
NCT02538588
Brief Title
Comparison of Amikacin Lung Delivery With Two Nebulizers
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
August 2015 (undefined)
Primary Completion Date
September 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Comparison between two modalities of nebulization.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Cystic Fibrosis
Keywords
Healthy Volunteers

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nebulizer 1
Arm Type
Experimental
Arm Description
Nebulization with akita nebulizer
Arm Title
Nebulizer 2
Arm Type
Active Comparator
Arm Description
Nebulization with eFlow nebulizer
Intervention Type
Device
Intervention Name(s)
Nebulizer 1
Other Intervention Name(s)
Akita
Intervention Type
Device
Intervention Name(s)
Nebulizer 2
Other Intervention Name(s)
eFlow
Primary Outcome Measure Information:
Title
Total urinary concentration of amikacin
Description
Pharmacokinetic study of the urinary excretion of amikacin after nebulization
Time Frame
24 hours after the nebulization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male healthy subjects Cystic fibrosis Exclusion Criteria: Kidney failure No pregnancy
Facility Information:
Facility Name
Cliniques universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne-Sophie Aubriot, PT
Phone
+3227647020
Email
as.aubriot@gmail.com
First Name & Middle Initial & Last Name & Degree
Anne-Sophie Aubriot, PT

12. IPD Sharing Statement

Learn more about this trial

Comparison of Amikacin Lung Delivery With Two Nebulizers

We'll reach out to this number within 24 hrs