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.
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
||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 September 22, 2014
Respiratory Tract Diseases
Lung Diseases, Obstructive
Immune System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Central Nervous System Agents