DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Which Apparatus for Inhaled Pentamidine?

Information source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

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

Phase: Phase 0

Status: Recruiting

Sponsored by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Official(s) and/or principal investigator(s):
Grégory Reychler, PhD, Principal Investigator, Affiliation: Cliniques universitaires Saint-Luc

Overall contact:
Nicolas Audag, PT, Email: nicolas.audag@uclouvain.be


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.

Clinical Details

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

Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Amikacine urinary dosage


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.


Inclusion Criteria:

- Be in good health

Exclusion Criteria:

- Known Tachycardia

- Renal Dysfunction

- Respiratory Diseases and history

Locations and Contacts

Nicolas Audag, PT, Email: nicolas.audag@uclouvain.be

Clinique universitaire Saint-Luc, Brussels, Belgium; Recruiting
Gregory Reychler, PhD
Gregory Reychler, PhD, Principal Investigator
Additional Information

Related publications:

Oudyi M, Chaumuzeau JP, Diot P, Dubus JC; GAT (Groupe Aérosolthérapie 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.

Kim CS, Garcia L, Wanner A. Actual pentamidine dose delivered by Respigard II nebulizer. Eur Respir J. 1995 Dec;8(12):2178-81.

Starting date: December 2013
Last updated: October 28, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017