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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00534625
Recruitment Status : Completed
First Posted : September 26, 2007
Last Update Posted : March 21, 2008
Information provided by:
Critical Therapeutics

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.

Condition or disease Intervention/treatment Phase
Asthma Drug: zileuton Drug: placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : September 2007
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Zileuton

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

Experimental: 3
300 mg zileuton by intravenous injection
Drug: zileuton
Single injection of zileuton 300 mg

Primary Outcome Measures :
  1. Effect on pulmonary function [ Time Frame: Within 0-12 hours after single dose ]

Secondary Outcome Measures :
  1. Safety assessments [ Time Frame: Within 0-36 hours after single dose ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00534625

Sponsors and Collaborators
Critical Therapeutics
Study Director: Dr. Cees Wortel Critical Therapeutics

Responsible Party: Cornelis Wortel MD, PhD/Acting CMO, Clinquest Inc Identifier: NCT00534625     History of Changes
Other Study ID Numbers: CTI-04-C07-202
First Posted: September 26, 2007    Key Record Dates
Last Update Posted: March 21, 2008
Last Verified: March 2008

Keywords provided by Critical Therapeutics:
Asthma, exacerbation, pulmonary function

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Lipoxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents
Antisickling Agents
Nucleic Acid Synthesis Inhibitors