Which Apparatus for Inhaled Pentamidine?

NCT02277808 | Unknown Early Phase 1

• 1 other identifier: Nebulizers for pentamidine
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

Pneumocystis; Nebulizer; Pentamidine

Outcome Measures

Primary Outcomes (1)

• Amikacine urinary dosage

  24 hours

Study Arms (2)

Respirgard II

ACTIVE COMPARATOR

Determination of pulmonary deposition

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

Isoneb

ACTIVE COMPARATOR

Determination of pulmonary deposition

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

Interventions

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

Isoneb; Respirgard II

Respirgard II DEVICE

Respirgard II

Isoneb® DEVICE

Isoneb

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be in good health

You may not qualify if:

• Known Tachycardia
• Renal Dysfunction
• Respiratory Diseases and history

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Clinique universitaire Saint-Luc

Brussels, Belgium

RECRUITING

Related Publications (3)

• 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.

  PMID: 22682591 BACKGROUND

• 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.

  PMID: 8681618 BACKGROUND

• 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.

  PMID: 8666114 BACKGROUND

MeSH Terms

Conditions

Pneumonia, Pneumocystis

Interventions

Amikacin

Condition Hierarchy (Ancestors)

Lung Diseases, Fungal; Mycoses; Bacterial Infections and Mycoses; Infections; Pneumocystis Infections; Respiratory Tract Infections; Pneumonia; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Kanamycin; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Grégory Reychler, PhD

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolas Audag, PT

CONTACT

nicolas.audag@uclouvain.be

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor in Physiotherapy

Study Record Dates

• First Submitted: October 27, 2014
• First Posted: October 29, 2014
• Study Start: December 1, 2013
• Primary Completion: October 1, 2014
• Last Updated: October 29, 2014

Record last verified: 2014-10

Locations

BE (1)