Inclusion Criteria:
- Male or female current tobacco smokers with more or equal to 10 pack years of
self-reported smoking exposure and an average of more or equal to 10 cigarettes/day
- ECOG performance status 0 or 1 (Karnofsky 70-100%)
- Total bilirubin less or equal to 2 X ULN
- Direct bilirubin less or equal to 2 X ULN
- AST (SGOT) less or equal to 2 X ULN
- ALT (SGPT) less or equal to 2 X ULN
- Alkaline phosphatase less or equal to 2 X ULN
- If the participant is female, of childbearing potential and not lactating, she has a
documented negative serum pregnancy test within 14 days prior to randomization
Exclusion Criteria:
- The participant has active cancer (excluding non-melanoma skin cancer)
- The participant has a history of curatively treated cancer with surgical therapy
finished within 6 months prior to the Screening visit; or has had chemotherapy,
cancer-related immunotherapy, hormonal therapy (other than HRT for menopause), or
radiation therapy within 12 months of the screening visit
- The participant has a chronic inflammatory condition, including but not limited to,
ulcerative colitis, Crohn's disease, rheumatoid arthritis, psoriasis, gout and
pancreatitis
- The participant has an ongoing or active infection, including but not limited to HIV,
pneumonia, urinary tract infection
- The participant has a history of NSAID use, including aspirin (low-dose aspirin also
prohibited) and selective COX-2 inhibitors within the previous 4 weeks
- The participant has used zileuton or a leukotriene receptor antagonist within the
previous 4 weeks
- The participant has a history of corticosteroid use (excluding topical nasal sprays
and dermal application) within the last 6 weeks
- The participant has an acute or chronic kidney disorder
- The participant exhibits clinical evidence of active liver disease or history of
chronic liver disease
- The participant has active cardiac disease, or a history of myocardial infarction,
angina or coronary artery disease within the past 6 months
- The participant has a history of a cerebrovascular accident (CVA) or transient
ischemic attack (TIA)
- The participant has a bleeding history
- The participant is taking drugs known to interact with zileuton or celecoxib,
including theophylline, warfarin, propranolol, fluconazole or lithium
- The participant has received any investigational medication within 30 days of the
screening visit or is scheduled to receive an investigational agent during the study
- The participant is pregnant or nursing; women must not be pregnant or lactating
- The participant is a female of child-bearing potential (women are considered not of
childbearing potential if they are at least two years postmenopausal and/or
surgically sterile) who has not used adequate contraception (abstinence; barrier
methods such as IUD, diaphragm with spermicidal gel, condom, or others; and hormonal
methods such as birth control pills or others) since her last menses prior to study
entry
- The participant is a female of child-bearing potential or male who does not agree to
use adequate contraception for the duration of study participation; should a woman
become pregnant or suspect she is pregnant while participating in this study, she
should inform her study physician immediately
- The participant has participated in the study previously and was withdrawn
- 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
- Pregnant or nursing participants or those who are HIV-positive will be excluded from
the study