Comparison of Amikacin Lung Delivery With Two Nebulizers

Not Applicable

• Conditions: Cystic Fibrosis; Healthy
• Interventions: Device: Nebulizer 1; Device: Nebulizer 2

• Registration Number: NCT02538588
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief Summary

Comparison between two modalities of nebulization.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-08-24
• Status Verified: 2015-09
• Primary Completion: 2015-09
• Study First Submitted QC: 2015-09-01
• Last Update Submitted: 2015-09-01
• Study First Posted: 2015-09-02
• Last Update Posted: 2015-09-02
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Male healthy subjects
• Cystic fibrosis

Exclusion Criteria

• Kidney failure
• No pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Nebulizer 1	Nebulizer 1	Nebulization with akita nebulizer
Nebulizer 2	Nebulizer 2	Nebulization with eFlow nebulizer

Primary Outcome Measures

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

Trial Locations

Locations (1)

Cliniques universitaires Saint-Luc; 🇧🇪 Brussels, Belgium