- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02201082
Evaluation of the Timing of the Nebulization Related to the Physiotherapy Session
August 24, 2015 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
The purpose of this study is to determine the optimal time for the nebulization depending on the respiratory physiotherapy session in cystic fibrosis patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
15
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
-
-
-
Brussels, Belgium, 1200
- Cliniques Universitaires Saint-Luc
-
-
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 50 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Stable cystic fibrosis patients older than 16 y.o.
- Pseudomonas aeruginosa colonization
- Hypersecretion
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: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Nebulization and airway clearance technique
nebulization combined to airway clearance
|
|
Active Comparator: Nebulization
nebulization
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Urinary excretion of amikacin
Time Frame: 24h after the nebulization
|
Pharmacokinetic study of the urinary excretion of amikacin after nebulization
|
24h after the nebulization
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Amikacin concentration into the sputum
Time Frame: At the end of the nebulization, an expected average of 20 minutes
|
At the end of the nebulization, an expected average of 20 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
September 1, 2012
Primary Completion (Actual)
July 1, 2013
Study Completion (Actual)
July 1, 2015
Study Registration Dates
First Submitted
February 20, 2014
First Submitted That Met QC Criteria
July 24, 2014
First Posted (Estimate)
July 25, 2014
Study Record Updates
Last Update Posted (Estimate)
August 25, 2015
Last Update Submitted That Met QC Criteria
August 24, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Physionebu
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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