Zileuton CR vs Placebo in Poorly Controlled Asthma Patients on Moderate Dose ICS

Exclusion Criteria

• •1. Diagnosis of COPD.
• •2. Uncontrolled systemic illness.
• •3. Hypersensitivity to any component of ZYFLO CR
• •4. Any patient with an unscheduled visit to an ER or hospital for asthma exacerbation within past 3 months.
• •5. History of hepatitis or active liver disease.
• •6. ALT greater than 3xULN.
• •7. History of HIV infection
• •8. Recent history of drug or alcohol abuse.
• •9. Oral corticosteroids within one month, cromolyn sodium or nedocromil within 14 days, theophylline, LABA, ZYFLO, or leukotriene modifiers, warfarin or propranolol, inhaled anti-cholinergics, or combination LABA/ICS.
• •10. Omalizumab within 3 months.
• •11. Pregnant female.
• •12. Participation with 30 days in investigational study.