Evaluation of Nebulization and Positive Expiratory Pressure Combination

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02535130

Enrollment

Registered

2015-08-28

Start date

2015-08-31

Completion date

2018-06-30

Last updated

2016-08-17

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

Conditions

Cystic Fibrosis, Healthy Subjects

Brief summary

The purpose of this study is to compare the efficiency of nebulization and positive expiratory pressure combination

Interventions

DEVICEPositive expiratory pressure

DRUGamikacine nebulization

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

16 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Stable cystic fibrosis patients older than 16 y.o. * Healthy subjects

Exclusion criteria

* Kidney failure * No pregnancy

Design outcomes

Primary

Measure	Time frame	Description
Urinary excretion of amikacin	24 hours after the nebulization	Pharmacokinetic study of the urinary excretion of amikacin after nebulization

Secondary

Measure	Time frame	Description
breathing pattern	participants will be recorded for the duration of the nebulization, an expected average of 15 minutes	recoding of frequency and tidal volume during the nebulization

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026