Evaluation of Nebulization and Positive Expiratory Pressure Combination

• Register: ClinicalTrials.gov
• Last refreshed on: 29 August 2016
• Main ID: NCT02535130
• Date of registration: 24/08/2015
• Prospective Registration: No
• Primary sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Public title: Evaluation of Nebulization and Positive Expiratory Pressure Combination
• Date of first enrolment: August 2015
• Target sample size: 15
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02535130
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Belgium

Contacts

• Name: Anne-Sophie Aubriot, PT

Key inclusion & exclusion criteria

Inclusion Criteria:

- Stable cystic fibrosis patients older than 16 y.o.

- Healthy subjects

Exclusion Criteria:

- Kidney failure

- No pregnancy



Age minimum: 16 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Healthy Subjects

Intervention(s)

Device: Positive expiratory pressure

Drug: amikacine nebulization

Primary Outcome(s)

Urinary excretion of amikacin [Time Frame: 24 hours after the nebulization]

Secondary Outcome(s)

breathing pattern [Time Frame: participants will be recorded for the duration of the nebulization, an expected average of 15 minutes]

Secondary ID(s)

NebuPEP

Source(s) of Monetary Support

Please refer to primary and secondary sponsors