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Which Apparatus for Inhaled Pentamidine?

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ClinicalTrials.gov Identifier: NCT02277808
Recruitment Status : Unknown
Verified October 2014 by G.Reychler, Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
Recruitment status was:  Recruiting
First Posted : October 29, 2014
Last Update Posted : October 29, 2014
Sponsor:
Information provided by (Responsible Party):
G.Reychler, Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Drug: 500mg Amikacine (Amukin®) diluted in 4mL NaCl (0,9%) Device: Respirgard II Device: Isoneb® Early Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : December 2013
Actual Primary Completion Date : October 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Pentamidine

Arms and Interventions
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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®


Outcome Measures
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Primary Outcome Measures :
  1. Amikacine urinary dosage [ Time Frame: 24 hours ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Be in good health

Exclusion Criteria:

  • Known Tachycardia
  • Renal Dysfunction
  • Respiratory Diseases and history
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02277808


Contacts
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Contact: Nicolas Audag, PT nicolas.audag@uclouvain.be

Locations
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Belgium
Clinique universitaire Saint-Luc Recruiting
Brussels, Belgium
Contact: Gregory Reychler, PhD         
Principal Investigator: Gregory Reychler, PhD         
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
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Principal Investigator: Grégory Reychler, PhD Cliniques universitaires Saint-Luc
More Information
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Publications:

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Responsible Party: G.Reychler, Doctor in Physiotherapy, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT02277808    
Other Study ID Numbers: Nebulizers for pentamidine
First Posted: October 29, 2014    Key Record Dates
Last Update Posted: October 29, 2014
Last Verified: October 2014
Keywords provided by G.Reychler, Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
Pneumocystis
Nebulizer
Pentamidine
Additional relevant MeSH terms:
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Amikacin
Anti-Bacterial Agents
Anti-Infective Agents