Quantifying Airway Inflammation With Radiologic Tests

Completed · Early Phase 1 · Has a placebo group

Conditions studied: Lung Inflammation

In brief

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).

Key facts

Study ID

NCT00741013

Run by

Washington University School of Medicine

People needed

22

Starts

2007-03-01

Expected to finish

2008-03-01

Last updated by the study team

2014-05-26

Who can join

Age: 19 and older, up to 44. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy, man or woman, any race or ethnicity, age 19 - 44 years old
• Screening FEV1 and FVC must be > 80% of predicted.
• Screening oxygen saturation by pulse oximetry is >97% on room air.
• Research volunteer must be capable of lying still and supine within the PET scanner for \~2 ½ hours.
• Research volunteer must be capable of fasting for 6 hours.

You may not qualify if…

• Pregnancy (confirmed by a qualitative urine hCG pregnancy test)
• Lactation.
• Actively menstruating at time of randomization
• History of tobacco use or has smoked other illicit drugs (marijuana, cocaine) in the past year.
• Research volunteer is currently taking any prescription medications.
• Research volunteer is at increased risk for radiation exposure (e.g. flight attendants)
• Research volunteer is enrolled in another research study of an investigational drug.
• Research volunteer has a known allergy to both trimethoprim/sulfamethoxazole and amoxicillin.
• Research volunteer has a known allergy to drugs routinely used during bronchoscopy.
• Research volunteer has a known allergy to lovastatin or rhAPC
• Fasting glucose at time of PET study > 150 mg/dl.
• Exclusion criteria related to use of rhAPC:
• Active or history of internal bleeding within the past 3 months
• History of hemorrhagic stroke within the past 3 months.
• History of intracranial or intraspinal surgery, or severe head trauma, within the past 3 months
• History of trauma with an increased risk of life-threatening bleeding within the past 3 months
• History of receiving thrombolytic therapy within the past 3 months.
• History of receiving oral anticoagulants or glycoprotein IIb/IIIa inhibitors within the past 3 months.
• History of using aspirin > 650 mg/d or other platelet inhibitors within the past 7 days.
• Any history of intracranial arteriovenous malformation or aneurysm
• Any history of a known bleeding diathesis
• Any history of chronic severe hepatic disease
• Presence of an epidural catheter
• Any history of intracranial neoplasm or mass lesion or evidence of cerebral herniation
• Use of heparin during past 7 days

Where it is running

• Washington University School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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