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

March 19, 2008 updated by: Critical Therapeutics

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Critical Therapeutics

Investigators

  • Study Director: Dr. Cees Wortel, Critical Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

September 24, 2007

First Submitted That Met QC Criteria

September 24, 2007

First Posted (Estimate)

September 26, 2007

Study Record Updates

Last Update Posted (Estimate)

March 21, 2008

Last Update Submitted That Met QC Criteria

March 19, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTI-04-C07-202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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