Quantifying Airway Inflammation With Radiologic Tests

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 instraspinal 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.