Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00299065
Status:
COMPLETED
Last Update Posted:
2007-09-26
First Post:
2006-03-02
Brief Title:
Safety Study of Zileuton Injection in Patients With Asthma
Sponsor:
Critical Therapeutics
Organization:
Critical Therapeutics
Study Overview
Official Title:
Assessment of Safety Tolerability and Pharmacokinetics of Zileuton Injection in Patients With Asthma
Status:
COMPLETED
Status Verified Date:
2007-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The prevalence of asthma continues to increase Despite the large number of available therapies many patients continue to require emergency deparment ED visits and intensive therapy However ED visits continue to be a major contributor to the healthcare cost of asthma treatment In the United States alone asthma is the 11th most common reason for ED visits with ED visits and hospitalizations accounting for almost 50 of the healthcare cost for asthma Additionally while only 20 of asthmatics have had ED visits or hospitalizations these patients account for over 80 of the direct costs for asthma treatment Current National Asthma Education and Prevention Program NAEPP guidelines regarding management of acute asthma exacerbations in the ED setting include oxygenation for most patients inhaled short-acting β2-agonists and systemic corticosteroids
Zileuton a specific 5-lipoxygenase inhibitor has been extensively studied in inflammatory diseases such as asthma which involve leukotrienes as mediators of inflammation Zileuton Immediate Release IR tablets Zyflo were approved by the Food and Drug Administration FDA in December 1996 for the prevention and treatment of asthma in adults and children 12 years of age and older The results of the 2 pivotal studies in asthmatics with zileuton IR tablets demonstrated that zileuton at a dose of 600 mg QID produced and maintained a lasting improvement of lung function In addition to the lasting effect of zileuton an acute bronchodilation as early as 60 minutes was observed after administration of the first 600 mg oral dose
This acute bronchodilator effect may benefit patients during an acute exacerbation of asthma when added to the usual care in the ED or clinic setting Critical Therapeutics has developed an injectable formulation of zileuton that will be explored for use in acute asthma exacerbations This initial study is intended to provide PK data information on safety and tolerability and some indication of pharmacologic activity as evidenced by lung function changes In an attempt to enhance the potential for observing effects on lung function only those patients with a demonstrated ability to respond by an increase in FEV1 of at least 10 within 3 hours after oral zileuton dosing will be enrolled
Zileuton a specific 5-lipoxygenase inhibitor has been extensively studied in inflammatory diseases such as asthma which involve leukotrienes as mediators of inflammation Zileuton Immediate Release IR tablets Zyflo were approved by the Food and Drug Administration FDA in December 1996 for the prevention and treatment of asthma in adults and children 12 years of age and older The results of the 2 pivotal studies in asthmatics with zileuton IR tablets demonstrated that zileuton at a dose of 600 mg QID produced and maintained a lasting improvement of lung function In addition to the lasting effect of zileuton an acute bronchodilation as early as 60 minutes was observed after administration of the first 600 mg oral dose
This acute bronchodilator effect may benefit patients during an acute exacerbation of asthma when added to the usual care in the ED or clinic setting Critical Therapeutics has developed an injectable formulation of zileuton that will be explored for use in acute asthma exacerbations This initial study is intended to provide PK data information on safety and tolerability and some indication of pharmacologic activity as evidenced by lung function changes In an attempt to enhance the potential for observing effects on lung function only those patients with a demonstrated ability to respond by an increase in FEV1 of at least 10 within 3 hours after oral zileuton dosing will be enrolled
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None