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

This study has been completed.
Sponsor:
Information provided by:
Critical Therapeutics
ClinicalTrials.gov Identifier:
NCT00534625
First received: September 24, 2007
Last updated: March 19, 2008
Last verified: March 2008
  Purpose

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 Intervention Phase
Asthma
Drug: zileuton
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Critical Therapeutics:

Primary Outcome Measures:
  • Effect on pulmonary function [ Time Frame: Within 0-12 hours after single dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety assessments [ Time Frame: Within 0-36 hours after single dose ] [ Designated as safety issue: Yes ]

Enrollment: 36
Study Start Date: September 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00534625

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

No publications provided

Responsible Party: Cornelis Wortel MD, PhD/Acting CMO, Clinquest Inc
ClinicalTrials.gov Identifier: NCT00534625     History of Changes
Other Study ID Numbers: CTI-04-C07-202
Study First Received: September 24, 2007
Last Updated: March 19, 2008
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Zileuton
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Lipoxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 20, 2014