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