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Sponsored by: |
Critical Therapeutics |
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Information provided by: | Critical Therapeutics |
ClinicalTrials.gov Identifier: | NCT00299065 |
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.
Condition | Intervention | Phase |
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Asthma |
Drug: Zileuton injection |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Assessment of Safety, Tolerability, and Pharmacokinetics of Zileuton Injection in Patients With Asthma |
Estimated Enrollment: | 60 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | June 2006 |
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Allergy & Asthma Specialist Medical Group | |
Huntington Beach, California, United States, 92647 | |
Allergy and Asthma Medical Group and Research Center | |
San Diego, California, United States, 92123 | |
United States, Colorado | |
Colorado Allergy and Asthma Centers, PC | |
Englewood, Colorado, United States, 80112 | |
United States, Massachusetts | |
Northeast Medical Research Associates | |
North Dartmouth, Massachusetts, United States, 02747 | |
United States, Minnesota | |
Clinical Research Institute | |
Minneapolis, Minnesota, United States, 55402 | |
United States, Missouri | |
The Clinical Research Center, L.L.C. | |
St. Louis, Missouri, United States, 63141 | |
United States, New Jersey | |
Princeton Center for Clinical Research | |
Skillman, New Jersey, United States, 08558 | |
United States, Ohio | |
Bernstein Clinical Research Center | |
Cincinnati, Ohio, United States, 45231 | |
United States, Oregon | |
Allergy Associates Research Center | |
Portland, Oregon, United States, 97213 | |
United States, Texas | |
Western Sky Medical Research | |
El Paso, Texas, United States, 79902 |
Study Director: | Dana Hilt, MD | Critical Therapeutics Incorporated |
Study ID Numbers: | CTI-04-C05-201 |
Study First Received: | March 2, 2006 |
Last Updated: | September 24, 2007 |
ClinicalTrials.gov Identifier: | NCT00299065 |
Health Authority: | United States: Food and Drug Administration |
Asthma, bronchial Asthma, exercise-induced Anti-asthmatic agents |
Asthma, Exercise-Induced Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Zileuton |
Lung Diseases Hypersensitivity, Immediate Asthma Leukotriene Antagonists Respiratory Hypersensitivity |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Bronchial Diseases Immune System Diseases Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Enzyme Inhibitors Pharmacologic Actions |
Lipoxygenase Inhibitors Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |