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

September 24, 2007
March 19, 2008
September 2007
March 2008   (final data collection date for primary outcome measure)
Effect on pulmonary function [ Time Frame: Within 0-12 hours after single dose ] [ Designated as safety issue: No ]
Effect on pulmonary function [ Time Frame: Within 0-12 hours after single dose ]
Complete list of historical versions of study NCT00534625 on ClinicalTrials.gov Archive Site
Safety assessments [ Time Frame: Within 0-36 hours after single dose ] [ Designated as safety issue: Yes ]
Safety assessments [ Time Frame: Within 0-36 hours after single dose ]
Not Provided
Not Provided
 
Assessment of PFT, Safety, and PK of Zileuton Injection in Asthma Patients
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Asthma
  • Drug: zileuton
    Single injection of zileuton 150 mg
  • Drug: placebo
    Single injection of placebo
  • Drug: zileuton
    Single injection of zileuton 300 mg
  • Placebo Comparator: 1
    Intervention: Drug: placebo
  • Experimental: 2
    150 mg zileuton by intravenous injection
    Intervention: Drug: zileuton
  • Experimental: 3
    300 mg zileuton by intravenous injection
    Intervention: Drug: zileuton
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
March 2008
March 2008   (final data collection date for primary outcome measure)

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.
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00534625
CTI-04-C07-202
No
Cornelis Wortel MD, PhD/Acting CMO, Clinquest Inc
Critical Therapeutics
Not Provided
Study Director: Dr. Cees Wortel Critical Therapeutics
Critical Therapeutics
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP