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Completed

NCT Number: NCT02201082

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

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

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

16 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Kidney failure
  • No pregnancy

Treatment and study plan

Airway clearance technique

Procedure

Amikacin nebulization

Drug

Primary outcomes

  1. Urinary excretion of amikacin

    Time frame: 24h after the nebulization

    Pharmacokinetic study of the urinary excretion of amikacin after nebulization

Secondary outcomes

  1. Amikacin concentration into the sputum

    Time frame: At the end of the nebulization, an expected average of 20 minutes

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2015
First posted
Jul 25, 2014
Registry last updated
Aug 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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