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

Study Overview
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Brief Summary
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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.

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

Conditions
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Asthma

Intervention / Treatment
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* Drug: zileuton
* Drug: placebo
* Drug: zileuton


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients 12 years of age or older Diagnosis of asthma by current ATS guidelines FEV1 of 4-80%. Reversibility of at least 13% after bronchodilator treatment Must be willing to with hold SABA for 6 hours and ICS for 24 hours prior to treatment. Informed consent Exclusion Criteria: Females of child bearing potential unless using birth control Uncontrolled systemic disease Known hypersensitivity to zileuton or components of zileuton injection. Upper or lower respiratory tract infection within the last 2 weeks Admission to hospital or ER visit for asthma exacerbation within the last 3 months Course of oral or parenteral steroids within the last 3 months Current smoker or H/O > 15 pack years Creatinine > 1.5 x ULN ALT > 3 x ULN BP < 100 (systolic) H/O HIV H/O alcohol or drug abuse Patients taking Xolair, theophylline, montelukast, zafirlukast, nedocromil, cromolyn sodium, Zyflo (within the past 7 days), warfarin, propranolol, inhaled anti-cholinergics, or LABA. Pregnant or breast feeding females Current participation or participation in an experimental drug study within 30 days.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br> | Drug: placebo<br>* Single injection of placebo<br>|
| Experimental: 2<br>150 mg zileuton by intravenous injection | Drug: zileuton<br>* Single injection of zileuton 150 mg<br>|
| Experimental: 3<br>300 mg zileuton by intravenous injection | Drug: zileuton<br>* Single injection of zileuton 300 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on pulmonary function |  | Within 0-12 hours after single dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessments |  | Within 0-36 hours after single dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, exacerbation, pulmonary function