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Evaluation of the Timing of the Nebulization Related to the Physiotherapy Session

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02201082
Enrollment
15
Registered
2014-07-25
Start date
2012-09-30
Completion date
2015-07-31
Last updated
2015-08-25

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

Conditions

Cystic Fibrosis

Brief summary

The purpose of this study is to determine the optimal time for the nebulization depending on the respiratory physiotherapy session in cystic fibrosis patients.

Interventions

PROCEDUREAirway clearance technique
DRUGAmikacin nebulization

Sponsors

Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
16 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

* Stable cystic fibrosis patients older than 16 y.o. * Pseudomonas aeruginosa colonization * Hypersecretion

Exclusion criteria

* Kidney failure * No pregnancy

Design outcomes

Primary

MeasureTime frameDescription
Urinary excretion of amikacin24h after the nebulizationPharmacokinetic study of the urinary excretion of amikacin after nebulization

Secondary

MeasureTime frame
Amikacin concentration into the sputumAt the end of the nebulization, an expected average of 20 minutes

Countries

Belgium

Outcome results

None listed

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