Assessment of PFT, Safety, and PK of Zileuton Injection in Asthma Patients
This study has been completed.
Information provided by:
First received: September 24, 2007
Last updated: March 19, 2008
Last verified: March 2008
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.
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
||Phase 2 Study of the Assessment of Pulmonary Function, Safety, Tolerability, and PK of Zileuton Injection in Patients With Chronic Stable Asthma
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 ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||March 2008 (Final data collection date for primary outcome measure)
Placebo Comparator: 1
Single injection of placebo
150 mg zileuton by intravenous injection
Single injection of zileuton 150 mg
300 mg zileuton by intravenous injection
Single injection of zileuton 300 mg
|Ages Eligible for Study:
||12 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00534625
||Dr. Cees Wortel
No publications provided
||Cornelis Wortel MD, PhD/Acting CMO, Clinquest Inc
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 24, 2007
||March 19, 2008
||United States: Food and Drug Administration
Keywords provided by Critical Therapeutics:
Asthma, exacerbation, pulmonary function
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 23, 2014
Immune System Diseases
Lung Diseases, Obstructive
Respiratory Tract Diseases
Anti-Inflammatory Agents, Non-Steroidal
Central Nervous System Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents