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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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7 September 2015 |
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Main ID: |
NCT02201082 |
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Date of registration:
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20/02/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Evaluation of the Timing of the Nebulization Related to the Physiotherapy Session
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Scientific title:
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Date of first enrolment:
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September 2012 |
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Target sample size:
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15 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02201082 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Belgium
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Stable cystic fibrosis patients older than 16 y.o.
- Pseudomonas aeruginosa colonization
- Hypersecretion
Exclusion Criteria:
- Kidney failure
- No pregnancy
Age minimum:
16 Years
Age maximum:
50 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis
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Intervention(s)
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Drug: Amikacin nebulization
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Procedure: Airway clearance technique
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Primary Outcome(s)
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Urinary excretion of amikacin
[Time Frame: 24h after the nebulization]
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Secondary Outcome(s)
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Amikacin concentration into the sputum
[Time Frame: At the end of the nebulization, an expected average of 20 minutes]
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Secondary ID(s)
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Physionebu
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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