Lung Inflammation Clinical Trial
Official title:
Imaging Biomarkers of Pulmonary Inflammation
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).
Status | Completed |
Enrollment | 22 |
Est. completion date | March 2008 |
Est. primary completion date | March 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 19 Years to 44 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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 - Platelet count <100,000 x 106/L - Prothrombin time-INR > 1.5 - SGOT >47 IU/L, SGPT > 53 IU/L, or bilirubin > 1.1 mg/dl - Any other condition in which bleeding constitutes a significant hazard or would be particularly difficult to manage because of its location. - Exclusion criteria related to use of lovastatin: - History of chronic active liver disease or acute liver disease within the past 3 months - SGOT >47 IU/L, SGPT > 53 IU/L, or bilirubin > 1.1 mg/dl. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Washington University School of Medicine | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine | Barnes-Jewish Hospital |
United States,
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;1 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Ki (Measure of [18F]Fluorodeoxyglucose ([18F]FDG) Uptake Determined by Patlak Graphical Analysis) in the Right Lung 24 Hours After LPS Instillation | Calculated Ki was used to measure the amount of lung inflammation before and after instillation of endotoxin to assess the effect of placebo, lovastatin, and rhAPC treatment | 24 hours after endotoxin instillation | No |
Secondary | Number of Total Nucleated Cells From Bronchoalveolar Lavage (BAL) Fluid 24 Hours After Endotoxin Instillation | Number of total nucleated cells isolated from the first aliquoe of BAL obtained to correlate with PET data. | 24 hours after endotoxin instillation | No |
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