Evaluation of Nebulization and Positive Expiratory Pressure Combination

Not Applicable

• Conditions: Healthy Subjects; Cystic Fibrosis
• Interventions: Drug: amikacine nebulization; Device: Positive expiratory pressure

• Registration Number: NCT02535130
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief Summary

The purpose of this study is to compare the efficiency of nebulization and positive expiratory pressure combination

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-08-24
• Study First Submitted QC: 2015-08-25
• Study First Posted: 2015-08-28
• Status Verified: 2016-08
• Primary Completion: 2016-08
• Last Update Submitted: 2016-08-16
• Last Update Posted: 2016-08-17
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Stable cystic fibrosis patients older than 16 y.o.
• Healthy subjects

Exclusion Criteria

• Kidney failure
• No pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Nebulization	amikacine nebulization	Control arm
Nebulization combined to positive expiratory pressure	amikacine nebulization	Experimental arm
Nebulization combined to positive expiratory pressure	Positive expiratory pressure	Experimental arm

Primary Outcome Measures

Name	Time	Method
Urinary excretion of amikacin	24 hours after the nebulization	Pharmacokinetic study of the urinary excretion of amikacin after nebulization

Secondary Outcome Measures

Name	Time	Method
breathing pattern	participants will be recorded for the duration of the nebulization, an expected average of 15 minutes	recoding of frequency and tidal volume during the nebulization

Trial Locations

Locations (1)

Cliniques universitaires Saint-Luc; 🇧🇪 Brussels, Belgium