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Zyflo (Zileuton) - Summary



Zileuton is an orally active inhibitor of 5-lipoxygenase, the enzyme that catalyzes the formation of leukotrienes from arachidonic acid.

ZYFLO is indicated for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older.

See all Zyflo indications & dosage >>


Media Articles Related to Zyflo (Zileuton)

Obscure Asthma Drug Shows Promise for Treating Diabetes
Source: Medscape Allergy & Clinical Immunology Headlines [2017.07.13]
A small proof-of-concept study has suggested that the asthma drug amlexanox could be repurposed to treat type 2 diabetes and may improve nonalcoholic fatty-liver disease.
Medscape Medical News

Asthma: Over the Counter Treatment
Source: MedicineNet Allergy Specialty [2017.07.12]
Title: Asthma: Over the Counter Treatment
Category: Diseases and Conditions
Created: 9/21/1999 12:00:00 AM
Last Editorial Review: 7/12/2017 12:00:00 AM

Maternal sugar intake linked to allergic asthma in offspring
Source: Respiratory / Asthma News From Medical News Today [2017.07.07]
New research examines the link between maternal intake of sugar during pregnancy and the risk of the offspring developing allergies and allergic asthma.

Steroids may do more harm than good in some cases of severe asthma
Source: Respiratory / Asthma News From Medical News Today [2017.07.07]
Researchers from the University of Pittsburgh Schools of the Health Sciences and UPMC have uncovered the molecular mechanism underlying corticosteroid resistance in severe asthma.

Repurposed asthma drug shows blood sugar improvement among some diabetics
Source: Diabetes News From Medical News Today [2017.07.07]
After 12 weeks of taking an anti-asthma drug, a subset of patients with type 2 diabetes showed a clinically significant reduction in blood glucose during a randomized, double blind...

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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 hospitalization. [2011]
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. [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.

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Clinical Trials Related to Zyflo (Zileuton)

Evaluating the Safety of Zileuton (Zyflo�) in Combination With Dasatinib (Sprycel�) in Chronic Myelogenous Leukemia [Recruiting]
Prospective nonrandomized phase I study The purpose of this study is to determine safety and efficacy of zileuton when added to dasatinib in patients with chronic myelogenous leukemia (CML).

Safety of Zileuton (Zyflo) in Combination With Imatinib Mesylate (Gleevec) in CML. [Terminated]
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.

Aspirin and Zileuton and Biomarker Expression in Nasal Tissue of Current Smokers [Not yet recruiting]
This randomized phase II trial studies the effects of aspirin and zileuton on genes related to tobacco use in current smokers. Smokers are at increased risk for developing lung and other cancers. Aspirin and zileuton may interfere with genes related to tobacco use and may be useful in preventing lung cancer in current smokers.

Trial of Zileuton CR in Children and Adults With Sickle Cell Disease [Completed]
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 With or Without Celecoxib As Chemopreventive Agents in Smokers [Completed]
The goal of this clinical research study is to learn how zileuton alone or the combination of zileuton and celecoxib may affect certain chemicals in the body that may be linked with a risk for smoking-related lung disease. These effects will be measured by a urine test

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Page last updated: 2017-07-13

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