Media Articles Related to Zyflo (Zileuton)
FDA Panel Backs Breo Ellipta for Asthma in Adults
Source: Medscape Medical News Headlines [2015.03.20]
The panel recommended against approving the long-acting beta-agonist combination therapy for children, primarily due to safety concerns.
Medscape Medical News
Study uncovers new clues about overproduction of mucus in asthma and COPD
Source: Respiratory / Asthma News From Medical News Today [2015.03.19]
New insights into how mucus is overproduced in diseases like asthma and COPD may lead to new treatments for these and other airway diseases.
FDA Staff Finds No New Safety Problems With Glaxo's Asthma Drug
Source: Medscape Allergy & Clinical Immunology Headlines [2015.03.18]
GlaxoSmithKline Plc's respiratory treatment for chronic breathing problems did not show any new safety problems while being tested to treat asthma, a preliminary review by U.S. Food and Drug Administration staff found.
Reuters Health Information
Bariatric surgery appears to cut risks for serious asthma-related events
Source: Respiratory / Asthma News From Medical News Today [2015.03.17]
Study finds that weight-loss surgery reduces asthma-associated emergency visits, hospitalizations by halfA study led by Massachusetts General Hospital (MGH) investigators suggests that bariatric...
Take action to decrease the burden of asthma in women
Source: Respiratory / Asthma News From Medical News Today [2015.03.10]
In the European Union women live on average five years longer than men1 but report having lower satisfaction with their health status.
Published Studies Related to Zyflo (Zileuton)
Randomized trial of zileuton for treatment of COPD exacerbations requiring hospitalization. [2011.02]
RATIONALE: Leukotrienes have been implicated in the pathogenesis of acute exacerbations of COPD, but leukotriene modifiers have not been studied as a possible therapy for exacerbations. OBJECTIVE: We sought to test the safety and efficacy of adding oral zileuton (a 5-lipoxygenase inhibitor) to usual treatment for acute exacerbations of COPD requiring hospitalization... CONCLUSIONS: While oral zileuton during COPD exacerbations that require hospital admission is safe and reduces urinary LTE(4) levels, we found no evidence suggesting that this intervention shortened hospital stay, with the limitation that our sample size may have been insufficient to detect a modest but potentially meaningful clinical improvement.
Randomized trial of zileuton for treatment of COPD exacerbations requiring
requiring hospitalization... CONCLUSIONS: While oral zileuton during COPD exacerbations that require
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. 
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.
Clinical Trials Related to Zyflo (Zileuton)
Safety of Zileuton (Zyflo) in Combination With Imatinib Mesylate (Gleevec) in CML. [Recruiting]
The leukemic stem cells (LSCs) are cells that self- renew and give rise to leukemia.
Eradication of LSC is required for cure. In chronic myelogenous leukemia (CML) LSCs are not
eradicated by imatinib (Gleevec) alone. Recent discovery by Dr. Shaoguang Li at University
of Massachusetts indicates that the LSCs can be targeted by a new drug zileuton (Chen et al.
Nature Genetics 2009; 41: 783-792). Zileuton (approved for asthma) will be tested in a
combination with Gleevec. This combination has not been used previously to treat leukemia.
This is a Phase I study. The goal of this research is to evaluate the safety of the standard
anti-cancer drug imatinib and experimental drug zileuton.
Trial of Zileuton CR in Children and Adults With Sickle Cell Disease [Recruiting]
The purpose of this research study is to test the safety of Zileuton and see what effects
(good and bad) it has on you, other children and adults with Sickle Cell Disease (SCD). The
investigators also want to see how Zileuton is handled by your body at different doses.
Zileuton is a drug that is approved by the Food and Drug Administration (FDA) for the
treatment of asthma for people age 12 and older. The FDA has not approved Zileuton for the
treatment of SCD, so it is being studied as an investigational drug for SCD through an
application to the FDA. In asthma patients, Zileuton helps by reducing inflammation. This
study will see if Zileuton helps to reduce inflammation associated with SCD.
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
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.