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

Information source: Critical Therapeutics
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: zileuton (Drug); placebo (Drug); zileuton (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Critical Therapeutics

Official(s) and/or principal investigator(s):
Dr. Cees Wortel, Study Director, Affiliation: Critical Therapeutics

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Effect on pulmonary function

Secondary outcome: Safety assessments

Eligibility

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Additional Information

Starting date: September 2007
Last updated: March 19, 2008

Page last updated: August 23, 2015

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