NCT02277808

Which Apparatus for Inhaled Pentamidine?

Which Apparatus for Inhaled Pentamidine? A Comparison of Drug Delivery to the Lung Between Two Nebulizers: The Respirgard II and the Isoneb.

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	500mg Amikacine (Amukin®) diluted in 4mL NaCl (0,9%)
DEVICE	Respirgard II
DEVICE	Isoneb®

Timeline

• Start date: 2013-12-01
• Primary completion: 2014-10-01
• First posted: 2014-10-29
• Last updated: 2014-10-29

Locations

1 site across 1 country: Belgium