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

NCT ID: NCT00534625

Last Updated: 2008-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2008-03-31

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.

Detailed Description

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Conditions

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Asthma

Keywords

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Asthma, exacerbation, pulmonary function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Single injection of placebo

2

150 mg zileuton by intravenous injection

Group Type EXPERIMENTAL

zileuton

Intervention Type DRUG

Single injection of zileuton 150 mg

3

300 mg zileuton by intravenous injection

Group Type EXPERIMENTAL

zileuton

Intervention Type DRUG

Single injection of zileuton 300 mg

Interventions

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zileuton

Single injection of zileuton 150 mg

Intervention Type DRUG

placebo

Single injection of placebo

Intervention Type DRUG

zileuton

Single injection of zileuton 300 mg

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Critical Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Clinquest Inc

Principal Investigators

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Dr. Cees Wortel

Role: STUDY_DIRECTOR

Critical Therapeutics

Other Identifiers

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CTI-04-C07-202

Identifier Type: -

Identifier Source: org_study_id