Which Apparatus for Inhaled Pentamidine?

Early Phase 1

• Conditions: Healthy
• Interventions: Drug: 500mg Amikacine (Amukin®) diluted in 4mL NaCl (0,9%); Device: Respirgard II; Device: Isoneb®

• Registration Number: NCT02277808
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief Summary

The reference nebulizer used for pentamidine nebulization is currently the Respirgard II ®, disposable pneumatic nebulizer. Other nebulizers are on the market and appear to have comparable properties and better availability to the hospital. Several studies remark that all nebulizers with comparable properties could be used for the nebulization.The aim of our work will be to evaluate and compare the pulmonary deposition between the reference nebulizer Respirgard II ®, and one of these nebulizers available on the market, the Isoneb ®. We will measure and compare these data's for each of the nebulizers via nebulization Amikacine and urinary dosage.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Status Verified: 2014-10
• Primary Completion: 2014-10
• Study First Submitted: 2014-10-27
• Study First Submitted QC: 2014-10-28
• Last Update Submitted: 2014-10-28
• Study First Posted: 2014-10-29
• Last Update Posted: 2014-10-29

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 10

Inclusion Criteria

• Be in good health

Exclusion Criteria

• Known Tachycardia
• Renal Dysfunction
• Respiratory Diseases and history

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Respirgard II	Respirgard II	Determination of pulmonary deposition
Isoneb	500mg Amikacine (Amukin®) diluted in 4mL NaCl (0,9%)	Determination of pulmonary deposition
Respirgard II	500mg Amikacine (Amukin®) diluted in 4mL NaCl (0,9%)	Determination of pulmonary deposition
Isoneb	Isoneb®	Determination of pulmonary deposition

Primary Outcome Measures

Name	Time	Method
Amikacine urinary dosage	24 hours

Trial Locations

Locations (1)

Clinique universitaire Saint-Luc; 🇧🇪 Brussels, Belgium