Aspirin and Zileuton and Biomarker Expression in Nasal Tissue of Current Smokers

Exclusion Criteria

• •History of allergic reaction to aspirin or attributed to compounds of similar chemical or biologic composition to aspirin, including other nonsteroidal anti-inflammatory drugs (NSAIDs)
• •Gastric intolerance attributable to ASA or NSAIDs
• •History of gastric ulcer within the past 5 years (with or without bleeding)
• •Use of ASA or NSAIDs for more than 5 days per month within 3 months of enrollment
• •Not willing or are unable to refrain from use of any non-study ASA, NSAIDs and leukotriene antagonists during the study period
• •Adult asthma
• •Chronic, current or recent (within the past three months) use of leukotriene antagonists
• •Require chronic anticoagulation or anti-platelet therapy
• •History of bleeding disorder or hemorrhagic stroke
• •Chronic, current or recent (within the past three months) use of glucocorticoids (systemic, topical and/or nasal sprays or steroid topical creams to large body surface area); use of steroid topical creams for small body areas (=\< 10% body surface) during study intervention is allowed
• •History of chronic sinusitis or recent nasal polyps
• •History of, or current, active or chronic liver disease even if transaminases have normalized
• •History of allergic reaction to zileuton or attributed to compounds of similar chemical or biologic composition to zileuton
• •Are taking drugs known to interact with zileuton, including theophylline, warfarin, and propranolol
• •Not willing or are unable to limit alcohol consumption to =\< 2 alcoholic beverages a day during the study period
• •Pregnant or lactating women; breastfeeding should be discontinued if the mother is treated with aspirin; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately
• •Participants may not be receiving any other investigational agents
• •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• •Have a known history of inability to absorb an oral agent
• •Invasive cancer within the past five years except non-melanoma skin cancer
• •Urine cotinine level, if collected at screening, does not confirm active smoking status