NCT01400568

Suitability of a Low Dose Lipopolysaccharide (LPS) Inhalation as a Challenge Model

A Methodological Pilot Study to Assess the Suitability of a Low Dose LPS Inhalation as a Challenge Model in Early Translational Drug Development

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Fraunhofer-Institute of Toxicology and Experimental Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This pilot study is planned to assess the suitability of a low dose Lipopolysaccharide (LPS) inhalation as a challenge model. As LPS effects are based on a different mode of action, this challenge model will provide the possibility to test a wider spectrum of potential drugs in the future. Provided that the LPS response is reproducible, it is planned to test whether a single high dose of inhaled steroid can serve as a positive control in the LPS model. Another major aim of the study is to test a variety of novel tools for the non-invasive assessment of airway inflammation induced by LPS challenge.

Detailed description

In this study, airway inflammation will be induced by LPS inhalation. In case a neutrophilic airway inflammation can be safely induced by inhaled LPS, the LPS challenge will be repeated. If neutrophil airway inflammation after LPS challenge is reproducible LPS challenge will be repeated after pre-treatment with a single high dose of inhaled fluticasone propionate. To determine airway inflammation, the subjects' exhaled breath will be analyzed by different techniques, and blood samples as well as induced sputum will be collected.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	LPS challenge with nebulized LPS	20,000 EU of Clinical Center Reference Endotoxine (CCRE) will be applied by an AKITA® Jet Nebulizer under the constant supervision of the site staff.
DRUG	fluticasone propionate (FP)	The dosage of FP will be 2 mg. This dosage will be inhaled by 4 puffs of Flutide® forte 500 Diskus® 500 µg / dose according to the package insert.

Timeline

• Start date: 2011-08-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2011-07-22
• Last updated: 2012-03-12

Locations

1 site across 1 country: Germany