NEWS HIGHLIGHTSMedia Articles Related to Zyflo (Zileuton)
Asthma Combo Seems Less Influenced by Genes (HealthDay)
Source: Y! Health Asthma News [2009.11.19]
HealthDay - THURSDAY, Nov. 19 (HealthDay News) -- People's genetic makeup has
been shown to affect how they respond to asthma medications, but a new
study finds that many people respond well to a particular combination
treatment regardless of their genes.
Annals Of Allergy, Asthma And Immunology To Be Published By Elsevier
Source: Allergy News From Medical News Today [2009.11.18]
Elsevier is pleased to announce that beginning with Volume 104 (2010) it will assume publication of the Annals of Allergy, Asthma & Immunology, the official journal of the American College of Allergy, Asthma & Immunology (ACAAI). The i>Annals of Allergy, Asthma & Immunology, published since 1942, will continue under the leadership of Editor Gailen D. Marshall, MD, PhD and a distinguished editorial board.
Folic Acid Late in Pregnancy Tied to Asthma in Kids
Source: MedicineNet Asthma Specialty [2009.11.16]
Title: Folic Acid Late in Pregnancy Tied to Asthma in Kids
Category: Health News
Created: 11/13/2009 2:10:00 PM
Last Editorial Review: 11/16/2009
New Research Shows Over-use Of Asthma Rescue Inhalers Substantially Reduced Through Pharmacist-initiated Physician Intervention
Source: Respiratory / Asthma News From Medical News Today [2009.11.13]
Research presented at the American College of Allergy, Asthma and Immunology (ACAAI) Annual Scientific Meeting shows that an intervention to reduce over-dispensing and waste of asthma medications can succeed without compromising patient safety and can result in substantial cost savings. Medco Health Solutions, Inc.
'The Pill' May Reduce Asthma Symptoms (HealthDay)
Source: Y! Health Asthma News [2009.11.13]
HealthDay - FRIDAY, Nov. 13 (HealthDay News) -- Women with asthma may notice that
their asthma symptoms get worse at certain times of the month. Now, a new
study confirms that fluctuating female hormone levels appear to affect
airway inflammation, but oral contraceptives might help ease those
changes.
Published Studies Related to Zyflo (Zileuton)
Efficacy of zileuton controlled-release tablets administered twice daily in the treatment of moderate persistent asthma: a 3-month randomized controlled study. [2007.08]
BACKGROUND: A controlled-release (CR) formulation of zileuton was developed to simplify administration from 600 mg 4 times daily (Zyflo) to 1,200 mg twice daily. OBJECTIVE: To evaluate the efficacy of zileuton CR, two 600-mg tablets twice daily, compared with placebo... CONCLUSIONS: Treatment with zileuton CR, 1,200 mg twice daily, resulted in a significant improvement in asthma control, and the safety and efficacy profile was similar to that observed with zileuton IR, 600 mg 4 times daily (Zyflo).
Clinical pattern of zileuton-associated liver injury: results of a 12-month study in patients with chronic asthma. [2007]
OBJECTIVE: Zileuton is a 5-lipoxygenase inhibitor approved by the US FDA in 1996 for the treatment of asthma in adults and children. During phase II/III clinical trials, zileuton was generally well tolerated, although elevations in ALT and AST levels were noted in some patients, and a single treated patient developed hepatocellular jaundice. To more fully characterise the hepatic effects of zileuton, and to establish appropriate monitoring guidelines, a 12-month open-label, safety surveillance study was conducted prior to FDA approval... CONCLUSIONS: This study established that liver chemistry monitoring is most effective in detecting elevation of ALT levels during the first 3 months of zileuton therapy and that with appropriate monitoring the risk of irreversible liver injury appears to be low.
Effects of 5-lipoxygenase inhibitor zileuton on airway responses to inhaled swine house dust in healthy subjects. [2006.02]
BACKGROUND: Inhalation of swine house dust induces acute airway inflammation and increased bronchial responsiveness in healthy subjects. OBJECTIVE: The aim of the study was to investigate whether 5-lipoxygenase products such as leukotrienes may have a role in this reaction... CONCLUSIONS: Pre-treatment with clinically recommended doses of the 5-lipoxygenase inhibitor zileuton did not affect the increase of bronchial reactivity induced by swine dust exposure. The intervention totally abolished the LTB(4) release in NAL fluid, but only partially inhibited the formation of leukotrienes as monitored by urinary levels. The enhanced increase of neutrophils and IL-6 in peripheral blood in the zileuton group, suggests that inhibition of 5-lipoxygenase may have pro-inflammatory effects.
5-lipoxygenase inhibitor zileuton attenuates ischemic brain damage: involvement of matrix metalloproteinase 9. [2009.10]
OBJECTIVES: Cerebral ischemia causes an increased expression and activation of 5-lipoxygenase (5-LOX) and matrix metalloproteinase 9 (MMP-9). Recent works demonstrated that the selective 5-LOX inhibitor zileuton down-regulates MMP-9 expression in vascular diseases and cancer. In the present work, we first studied the neuroprotective effect of zileuton on focal cerebral ischemia in rats and further investigated the effect of zileuton on the expression of 5-LOX and MMP-9 in ischemic brain... CONCLUSION: These results suggest that selective 5-LOX inhibitor zileuton attenuates ischemic brain damage in rats, which may be partly associated with MMP-9 inhibition.
Role of add-on zileuton on total exhaled, large airway, and small airway/alveolar nitric oxide in moderate-severe persistent adult asthmatics on fluticasone 250mug/Salmeterol 50mug. [2009.05.23]
BACKGROUND: Measuring non-invasive exhaled biomarkers of inflammation may be important in monitoring asthma therapy. OBJECTIVE: Evaluate exhaled nitric oxide with add-on leukotriene synthesis inhibitor in moderate-severe persistent asthmatics on combination controllers... CONCLUSION: In stable, moderate-severe persistent adult asthmatics, large airway NO flux, small airway/alveolar CANO, and Juniper airway scores, were not significantly different on F/S bid vs F/S bid plus Zileuton for 4 weeks, despite significant small increase in FEV(1) over FVC ratio and FEV(1)% predicted.
Clinical Trials Related to Zyflo (Zileuton)
Zileuton and Exhaled Nitric Oxide in Asthmatics [Completed]
Evaluate the additive role of zileuton 600mg qid to clinically stable asthmatics on Advair
250/50 bid. Since asthma is an endogenous inflammatory disease there usually is increased
total exhaled, bronchial and alveolar nitric oxide which are markers of eosinophilic driven
pathways of inflammation. The addition of zileuton which is a leukotriene synthesis inhibitor
by itself or together with inhaled corticosteroids should reduce nitric oxide gas exchange.
Assessment of PFT, Safety, and PK of Zileuton Injection in Asthma Patients [Completed]
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.
Zileuton CR vs Placebo in Poorly Controlled Asthma Patients on Moderate Dose ICS [Terminated]
Asthma is a chronic inflammatory disorder of the airways with a variety of inflammatory
processes contributing to the pathogenesis. The inflammation leads to a state of increased
airway responsiveness and reversible airway obstruction that causes the recurrent symptoms of
asthma. Despite the variety of treatments available for asthma, none are curative, and the
disease continues to place a burden on society in terms of morbidity, reduced quality of life
(QOL), and ever increasing healthcare costs. The prevalence of asthma continues to increase
with current data suggesting that since 1980, adult asthma cases have increased by 75% and in
children under 5 years of age the prevalence has increased by 160%.1 Additionally, studies
have suggested that the disease severity has been underestimated and that more patients may
be classified as having moderate to severe persistent disease. 2 Inhaled corticosteroids (ICS)
have been the cornerstone of anti-inflammatory treatment for decades and have been shown to
improve lung function, decrease symptoms, and reduce asthma exacerbations. 3 However, many
patients are still inadequately controlled despite treatment according to current asthma
management guidelines and have a significant unmet medical need. Such patients are at high
risk of serious exacerbations and asthma-related mortality. 4 Combining long-acting
β2-agonists (LABAs) with low dose ICS has been shown to improve asthma control over using
higher doses of ICS alone. However, LABAs act mainly at the bottom of the inflammatory
cascade and there are concerns that they may mask underlying inflammation. 5 Recently,
leukotriene receptor antagonists have been added to ICS as second-line therapy in the
management of asthma. Zileuton has been extensively studied in inflammatory diseases such as
asthma, in which leukotrienes mediate inflammation.
The aim of this study is to assess the effect of zileuton controlled-release (CR; 1200 mg
2-times daily [BID]) on pulmonary function, asthma control, and symptomatic response in adult
patients with asthma poorly controlled on moderate dose ICS.
Safety Study of Zileuton Injection in Patients With Asthma [Completed]
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 in Preventing Lung Cancer in Patients With Bronchial Dysplasia [Active, not recruiting]
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the
development or recurrence of cancer. The use of zileuton may be an effective way to prevent
lung cancer in patients who have bronchial dysplasia.
PURPOSE: Randomized phase II trial to study the effectiveness of zileuton in preventing lung
cancer in patients who have bronchial dysplasia.
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