NCT04914273

Use of Exhaled Particles to Assess Lung Pharmacokinetics

Exhaled Particles in Lung Pharmacokinetics

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Fraunhofer-Institute of Toxicology and Experimental Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Healthy
• Lung Pharmacokinetic

Interventions

Type	Name	Description
DRUG	Inhalation Spray	400 mcg salbutamol administered per metered dose inhaler
DRUG	Tablet	8 mg salbutamol administered per tablet for ingestion

Timeline

• Start date: 2021-06-14
• Primary completion: 2021-08-03
• Completion: 2021-08-03
• First posted: 2021-06-04
• Last updated: 2024-10-15

Locations

1 site across 1 country: Germany