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OpenTrials
Completed

NCT Number: NCT00534625

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

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

zileuton

Drug

Single injection of zileuton 150 mg

Placebo

Drug

Single injection of placebo

Primary outcomes

  1. Effect on pulmonary function

    Time frame: Within 0-12 hours after single dose

Secondary outcomes

  1. Safety assessments

    Time frame: Within 0-36 hours after single dose

Sponsors and collaborators

Lead sponsor

Critical Therapeutics

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Sep 26, 2007
Registry last updated
Mar 21, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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