Conditions: Lung Inflammation
Keywords: randomized positron emission tomography lung inflammation lovastatin recombinant human activated protein C endotoxin fluorodeoxyglucose
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 22
Healthy volunteers: yes

Brief 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.

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: placebo pill and placebo IV intervention 2: Lovastatin pill and placebo IV intervention 3: placebo pill and recombinant human activated protein C IV intervention 4: Endotoxin
Intervention descriptions: intervention 1: 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 intervention 2: 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 intervention 3: 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 intervention 4: 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.

Protocol document: