NCT00741013

Quantifying Airway Inflammation With Radiologic Tests

Imaging Biomarkers of Pulmonary Inflammation

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 19 Years – 44 Years
• Healthy volunteers: Accepted

Summary

In this randomized, double-blind, placebo controlled trial we used positron emission tomography to determine if lovastatin or recombinant human activated protein C exhibit anti-inflammatory effects in humans following intrabronchial installation of lipopolysaccharide (LPS or endotoxin).

Detailed description

Quantitative, noninvasive biomarkers for lung-specific inflammation have yet to be developed but can potentially contribute significantly to the development of therapies to treat lung inflammation. The purpose of this study was to demonstrate that positron emission tomographic (PET) imaging with \[18F}fluorodeoxyglucose (FDG-PET) can be used to quantify the change in lung inflammation in healthy volunteers.

Conditions

• Lung Inflammation

Interventions

Type	Name	Description
DRUG	placebo pill and placebo IV	Placebo pill every four hours, starting 16 hours before intrabronchial LPS and ending 24 hours after intrabronchial LPS Placebo IV starting 2 hours before intrabronchial LPS and ending 24 hours after intrabronchial LPS
DRUG	Lovastatin pill and placebo IV	lovastatin pill every four hours, total of 80 milligrams a day, starting 16 hours before intrabronchial LPS and ending 24 hours after intrabronchial LPS Placebo IV starting 2 hours before intrabronchial LPS and ending 24 hours after intrabronchial LPS
DRUG	placebo pill and recombinant human activated protein C IV	placebo pill every four hours, total of 80 milligrams a day, starting 16 hours before intrabronchial LPS and ending 24 hours after intrabronchial LPS recombinant human activated protein C IV 24 micrograms per kg per hour starting 2 hours before intrabronchial LPS and ending 24 hours after intrabronchial LPS
BIOLOGICAL	Endotoxin	Endotoxin 4 ng/kg instilled bronchoscopically in all volunteers 12 hours after starting lovastatin treatment and 2 hours after starting recombinant human activated protein C treatment.

Timeline

• Start date: 2007-03-01
• Primary completion: 2008-03-01
• Completion: 2008-03-01
• First posted: 2008-08-25
• Last updated: 2014-05-26
• Results posted: 2014-05-26

Locations

1 site across 1 country: United States