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

Primary Purpose

Asthma

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

zileuton

placebo

zileuton

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, exacerbation, pulmonary function

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Arm Description

150 mg zileuton by intravenous injection

300 mg zileuton by intravenous injection

Outcomes

Primary Outcome Measures

Effect on pulmonary function

Secondary Outcome Measures

Safety assessments

Full Information

NCT ID

NCT00534625

First Posted

September 24, 2007

Last Updated

March 19, 2008

Sponsor

Critical Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT00534625

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

March 2008

Overall Recruitment Status

Completed

Study Start Date

September 2007 (undefined)

Primary Completion Date

March 2008 (Actual)

Study Completion Date

March 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Critical Therapeutics

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

Asthma, exacerbation, pulmonary function

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Placebo Comparator

Arm Title

Arm Type

Experimental

Arm Description

150 mg zileuton by intravenous injection

Arm Title

Arm Type

Experimental

Arm Description

300 mg zileuton by intravenous injection

Intervention Type

Drug

Intervention Name(s)

zileuton

Intervention Description

Single injection of zileuton 150 mg

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

Single injection of placebo

Intervention Type

Drug

Intervention Name(s)

zileuton

Intervention Description

Single injection of zileuton 300 mg

Primary Outcome Measure Information:

Title

Effect on pulmonary function

Time Frame

Within 0-12 hours after single dose

Secondary Outcome Measure Information:

Title

Safety assessments

Time Frame

Within 0-36 hours after single dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dr. Cees Wortel

Organizational Affiliation

Critical Therapeutics

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

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

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