Status:
COMPLETED
Quantifying Airway Inflammation With Radiologic Tests
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
Barnes-Jewish Hospital
Conditions:
Lung Inflammation
Eligibility:
All Genders
19-44 years
Phase:
EARLY_PHASE1
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...
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. Th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00741013
Start Date
March 1 2007
End Date
March 1 2008
Last Update
May 26 2014
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110