Assessment of Inflammatory Mediators (AIM)

Inclusion Criteria:

• Male or female 10 years of age or older.

• Confirmed diagnosis of CF based on the following criteria:

  • positive sweat chloride >= 60 mEq/liter (by pilocarpine iontophoresis) and/or
  • a genotype with two identifiable mutations consistent with CF, and
  • accompanied by one or more clinical features consistent with the CF phenotype
• FEV1 >= 50% predicted value (subjects >= 10 - <18 years of age) or >= 40% predicted value (subjects >= 18 years of age)
• Clinically stable with no evidence of acute upper or lower respiratory tract infection or current pulmonary exacerbation within the 14 days prior to Visit 1 (Day 0)
• Ability to reproducibly perform spirometry and peak flow measurements
• Ability to understand and sign a written informed consent or assent and comply with the requirements of the study

Exclusion Criteria:

• Use of an investigational agent within the 4-week period prior to Visit 1 (Day 0)
• Chronic daily use of ibuprofen, celecoxib, or other selective COX-2 inhibitors, other NSAIDs, or systemic or inhaled corticosteroids within the 4 weeks prior to Visit 1 (Day 0) or acute usage within 72 hours prior to Visit 1 (Day 0)
• History of hypersensitivity to beta-agonists
• History of hypersensitivity to sulfonamides, aspirin, or other NSAIDs
• Oxygen saturation < 92% on room air at Visit 1 (Day 0)
• Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
• History of hemoptysis >= 30 cc per episode during the 30 days prior to Visit 1 (Day 0)
• Significant history of hepatic, cardiovascular, renal, neurological, hematologic, or peptic ulcer disease
• SGOT (ALT) or SGPT (AST) > 3 times the upper limit of normal at screening, documented biliary cirrhosis, or portal hypertension
• Creatinine > 1.8 mg/dL at screening
• Inability to swallow pills
• Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the subject or the quality of the data