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

Phase 2 Study of the Assessment of Pulmonary Function, Safety, Tolerability, and PK of Zileuton Injection in Patients With Chronic Stable Asthma

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00534625

Enrollment

Registered

2007-09-26

Start date

2007-09-30

Completion date

2008-03-31

Last updated

2008-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Asthma, exacerbation, pulmonary function

Brief summary

A single intravenous injection of zileuton (150 or 300 mg) will be administered to patients with stable asthma. The goals will be to determine if zileuton i.v. can produce a rapid increase in FEV1/PEFR and when this effect can be seen. The safety of this route of administration of zileuton will also be studied. PK will be obtained in a population based method.

Interventions

DRUGzileuton

Single injection of zileuton 150 mg

DRUGplacebo

Single injection of placebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Male or female patients 12 years of age or older 2. Diagnosis of asthma by current ATS guidelines 3. FEV1 of 4-80%. 4. Reversibility of at least 13% after bronchodilator treatment 5. Must be willing to with hold SABA for 6 hours and ICS for 24 hours prior to treatment. 6. Informed consent

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Effect on pulmonary function	Within 0-12 hours after single dose

Secondary

Measure	Time frame
Safety assessments	Within 0-36 hours after single dose

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026