Back to resultsEvaluation of the Timing of the Nebulization Related to the Physiotherapy Session
Primary Purpose
Cystic Fibrosis
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Airway clearance technique
Amikacin 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.
- Pseudomonas aeruginosa colonization
- Hypersecretion
Exclusion Criteria:
- Kidney failure
- No pregnancy
Sites / Locations
- Cliniques universitaires Saint-Luc
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Nebulization and airway clearance technique
Nebulization
Arm Description
nebulization combined to airway clearance
nebulization
Outcomes
Primary Outcome Measures
Urinary excretion of amikacin
Pharmacokinetic study of the urinary excretion of amikacin after nebulization
Secondary Outcome Measures
Amikacin concentration into the sputum
Full Information
NCT ID
NCT02201082
First Posted
February 20, 2014
Last Updated
August 24, 2015
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1. Study Identification
Unique Protocol Identification Number
NCT02201082
Brief Title
Evaluation of the Timing of the Nebulization Related to the Physiotherapy Session
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2015 (Actual)
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 determine the optimal time for the nebulization depending on the respiratory physiotherapy session in cystic fibrosis patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nebulization and airway clearance technique
Arm Type
Experimental
Arm Description
nebulization combined to airway clearance
Arm Title
Nebulization
Arm Type
Active Comparator
Arm Description
nebulization
Intervention Type
Procedure
Intervention Name(s)
Airway clearance technique
Intervention Type
Drug
Intervention Name(s)
Amikacin nebulization
Primary Outcome Measure Information:
Title
Urinary excretion of amikacin
Description
Pharmacokinetic study of the urinary excretion of amikacin after nebulization
Time Frame
24h after the nebulization
Secondary Outcome Measure Information:
Title
Amikacin concentration into the sputum
Time Frame
At the end of the nebulization, an expected average of 20 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Stable cystic fibrosis patients older than 16 y.o.
Pseudomonas aeruginosa colonization
Hypersecretion
Exclusion Criteria:
Kidney failure
No pregnancy
Facility Information:
Facility Name
Cliniques universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
12. IPD Sharing Statement
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Evaluation of the Timing of the Nebulization Related to the Physiotherapy Session
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