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NCT02277808 Clinical Trial

Which Apparatus for Inhaled Pentamidine?

Healthy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02277808
Other study ID # Nebulizers for pentamidine
Secondary ID
Status Recruiting
Phase Phase 0
First received October 27, 2014
Last updated October 28, 2014
Start date December 2013

Study information
Verified date October 2014
Source Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Contact Nicolas Audag, PT
Email nicolas.audag@uclouvain.be
Is FDA regulated No
Health authority Belgium: Ethics Commitee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 10
Est. completion date
Est. primary completion date October 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Be in good health

Exclusion Criteria:

- Known Tachycardia

- Renal Dysfunction

- Respiratory Diseases and history

Study Design

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

Related Conditions & MeSH terms

Intervention

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

Device:
• Respirgard II

• Isoneb®

Locations
Country Name City State
Belgium Clinique universitaire Saint-Luc Brussels

Sponsors (1)
Lead Sponsor Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

References & Publications (3)

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

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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Amikacine urinary dosage 24 hours Yes
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