Which Apparatus for Inhaled Pentamidine?

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

Status

UNKNOWN

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02277808

Enrollment

Registered

2014-10-29

Start date

2013-12-31

Completion date

Unknown

Last updated

2014-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Pneumocystis, Nebulizer, Pentamidine

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.

Interventions

DRUG500mg Amikacine (Amukin®) diluted in 4mL NaCl (0,9%)

DEVICERespirgard II

DEVICEIsoneb®

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Be in good health

Exclusion criteria

* Known Tachycardia * Renal Dysfunction * Respiratory Diseases and history

Design outcomes

Primary

Measure	Time frame
Amikacine urinary dosage	24 hours

Countries

Belgium

Contacts

Primary ContactNicolas Audag, PT

nicolas.audag@uclouvain.be

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026