Back to resultsEvaluation of Nebulization and Positive Expiratory Pressure Combination
Primary Purpose
Cystic Fibrosis, Healthy Subjects
Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Positive expiratory pressure
amikacine nebulization
Sponsored by
About this trial
This is an interventional treatment trial for Cystic Fibrosis
Eligibility Criteria
Inclusion Criteria:
- Stable cystic fibrosis patients older than 16 y.o.
- Healthy subjects
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
Nebulization combined to positive expiratory pressure
Nebulization
Arm Description
Experimental arm
Control arm
Outcomes
Primary Outcome Measures
Urinary excretion of amikacin
Pharmacokinetic study of the urinary excretion of amikacin after nebulization
Secondary Outcome Measures
breathing pattern
recoding of frequency and tidal volume during the nebulization
Full Information
NCT ID
NCT02535130
First Posted
August 24, 2015
Last Updated
August 16, 2016
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1. Study Identification
Unique Protocol Identification Number
NCT02535130
Brief Title
Evaluation of Nebulization and Positive Expiratory Pressure Combination
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2015 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
June 2018 (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
The purpose of this study is to compare the efficiency of nebulization and positive expiratory pressure combination
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis, Healthy Subjects
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nebulization combined to positive expiratory pressure
Arm Type
Experimental
Arm Description
Experimental arm
Arm Title
Nebulization
Arm Type
Active Comparator
Arm Description
Control arm
Intervention Type
Device
Intervention Name(s)
Positive expiratory pressure
Intervention Type
Drug
Intervention Name(s)
amikacine nebulization
Primary Outcome Measure Information:
Title
Urinary excretion of amikacin
Description
Pharmacokinetic study of the urinary excretion of amikacin after nebulization
Time Frame
24 hours after the nebulization
Secondary Outcome Measure Information:
Title
breathing pattern
Description
recoding of frequency and tidal volume during the nebulization
Time Frame
participants will be recorded for the duration of the nebulization, an expected average of 15 minutes
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:
Stable cystic fibrosis patients older than 16 y.o.
Healthy subjects
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
Evaluation of Nebulization and Positive Expiratory Pressure Combination
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