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.

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium
    • Recruiting
    • Clinique Universitaire Saint-Luc
    • Contact: Gregory Reychler, PhD
    • Principal Investigator: Gregory Reychler, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Be in good health

Exclusion Criteria:

• Known Tachycardia
• Renal Dysfunction
• Respiratory Diseases and history

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Respirgard II; Determination of pulmonary deposition	Drug: 500mg Amikacine (Amukin®) diluted in 4mL NaCl (0,9%); Device: Respirgard II
Active Comparator: Isoneb; Determination of pulmonary deposition	Drug: 500mg Amikacine (Amukin®) diluted in 4mL NaCl (0,9%); Device: Isoneb®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Amikacine urinary dosage	24 hours

Collaborators and Investigators

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Investigators: Principal Investigator: Grégory Reychler, PhD, Cliniques Universitaires Saint-Luc

Publications and helpful links

General Publications

• Oudyi M, Chaumuzeau JP, Diot P, Dubus JC; GAT (Groupe Aerosoltherapie de la SPLF). [Use of pentamidine nebulization in children]. Rev Mal Respir. 2012 May;29(5):656-63. doi: 10.1016/j.rmr.2012.02.003. Epub 2012 Mar 28. French.
• McIvor RA, Berger P, Pack LL, Rachlis A, Chan CK. An effectiveness community-based clinical trial of Respirgard II and Fisoneb nebulizers for Pneumocystis carinii prophylaxis with aerosol pentamidine in HIV-infected individuals. Toronto Aerosol Pentamidine Study (TAPS) Group. Chest. 1996 Jul;110(1):141-6. doi: 10.1378/chest.110.1.141.
• Kim CS, Garcia L, Wanner A. Actual pentamidine dose delivered by Respigard II nebulizer. Eur Respir J. 1995 Dec;8(12):2178-81. doi: 10.1183/09031936.95.08122178.

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: October 27, 2014
• First Submitted That Met QC Criteria: October 28, 2014
• First Posted (Estimate): October 29, 2014

Study Record Updates

• Last Update Posted (Estimate): October 29, 2014
• Last Update Submitted That Met QC Criteria: October 28, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: Nebulizer; Pentamidine; Pneumocystis
• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Bacterial Agents; Amikacin
• Other Study ID Numbers: Nebulizers for pentamidine