Quantifying Airway Inflammation With Radiologic Tests

Phase 0 Completed 22 enrolled Washington University School of Medicine Barnes-Jewish Hospital · collab

RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

Start: 2007-03
Primary completion: 2008-03
Completion: 2008-03

Outcome

Met primary endpoint

paper There was a statistically significant decrease in K(i) in the lovastatin-treated group that was not seen in the placebo-treated group PMID 19574441 ↗

registry Placebo Pill and Intravenous (i.v.) Placebo vs Lovastatin Pill and i.v. Placebo vs Placebo Pill and Recombinant Human Activated Protein C i.v.; p <0.05; ANOVA NCT00741013 ↗

Publications

Results Chen DL, Bedient TJ, Kozlowski J, Rosenbluth DB, Isakow W, Ferkol TW, Thomas B, Mintun MA, Schuster DP, Walter MJ. [18F]fluorodeoxyglucose positron emission tomography for lung antiinflammatory response evaluation. Am J Respir Crit Care Med. 2009 Sep 15;180(6):533-9. doi: 10.1164/rccm.200904-0501OC. Epub 2009 Jul 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lovastatin	Small molecule	80 mg	Oral
Subject	recombinant human activated protein C	Protein / enzyme biologic	24 ug/kg	Intravenous