1. Females of child bearing potential unless using birth control

2. Uncontrolled systemic disease

3. Known hypersensitivity to zileuton or components of zileuton injection.

4. Upper or lower respiratory tract infection within the last 2 weeks

5. Admission to hospital or ER visit for asthma exacerbation within the last 3 months

6. Course of oral or parenteral steroids within the last 3 months

7. Current smoker or H/O \> 15 pack years

8. Creatinine \> 1.5 x ULN

9. ALT \> 3 x ULN

10. BP \< 100 (systolic)

11. H/O HIV

12. H/O alcohol or drug abuse

13. Patients taking Xolair, theophylline, montelukast, zafirlukast, nedocromil, cromolyn sodium, Zyflo (within the past 7 days), warfarin, propranolol, inhaled anti-cholinergics, or LABA.

14. Pregnant or breast feeding females

15. Current participation or participation in an experimental drug study within 30 days.

Assessment of PFT, Safety, and PK of Zileuton Injection in Asthma Patients

What this study is about