CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 22 enrolled
Drug / intervention
placebo pill and placebo IV +3 moredrug
Likely dose
Lovastatin pill and placebo IV 80 milligramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00741013
NCT00741013Early Ph 1Completed
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Imaging Biomarkers of Pulmonary Inflammation

Washington University School of Medicine·interventional·Posted Aug 25, 2008·Updated May 26, 2014

In Brief

A Early Phase 1 clinical trial evaluating placebo pill and placebo IV, Lovastatin pill and placebo IV, and 2 other interventions for Lung Inflammation. Completed, enrolled 22 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Inflammation
CountriesUnited States
CollaboratorsBarnes-Jewish Hospital

Timeline

Early Ph 1CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 25, 2008
Enrollment StartMar 1, 2007
Primary CompletionMar 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 17.9 years ago

Interventions

placebo pill and placebo IVdrug

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

Lovastatin pill and placebo IVdrug

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

placebo pill and recombinant human activated protein C IVdrug

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

Endotoxinbiological

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.