Which Apparatus for Inhaled Pentamidine?

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status and phase: Unknown; Early Phase 1

Conditions: Healthy

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02277808

Nebulizers for pentamidine

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Be in good health

Exclusion criteria

• Known Tachycardia
• Renal Dysfunction
• Respiratory Diseases and history

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

10 participants in 2 patient groups

Respirgard II

Active Comparator group

Description:

Determination of pulmonary deposition

Treatment:

Device: Respirgard II

Drug: 500mg Amikacine (Amukin®) diluted in 4mL NaCl (0,9%)

Isoneb

Active Comparator group

Description:

Determination of pulmonary deposition

Treatment:

Device: Isoneb®

Drug: 500mg Amikacine (Amukin®) diluted in 4mL NaCl (0,9%)