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Clinical Trial Summary

This research project in humans aims at increasing the general understanding of lung pharmakokinetic by sampling exhaled particles. The central hypothesis of this study is that pharmacokinetics of Salbutamol (model drug) can be monitored in exhaled particles.


Clinical Trial Description

The aim of the present study is to increase the general understanding of lung pharmakokinetic by systematically sampling exhaled particles at pre-specified quantities to reproduce and extent existing pilot data. For comparison, samples of blood plasma and nasal filter samples (nasosorption) will be collected for pharmakokinetic analyzes. Nasosorption will be performed to explore the possibility of detecting drug concentrations in nasal filter paper samples. Salbutamol will be administered by inhalation and orally in a cross-over study design and both application routes shall be comparised regarding the detection of pharmakokinetic data. The aim of the study is not to generate safety or efficacy data of the selected licensed drugs. The choice of drugs is based on general considerations regarding therapy of airway diseases and the physical-chemical properties of the compounds. It is not driven by the compounds per se. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04914273
Study type Interventional
Source Fraunhofer-Institute of Toxicology and Experimental Medicine
Contact
Status Completed
Phase N/A
Start date June 14, 2021
Completion date August 3, 2021

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