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Zyflo CR (Zileuton) - Summary

 
 



ZYFLO CR SUMMARY

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

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

ZYFLO CR is not indicated for use in the reversal of bronchospasm in acute asthma attacks. Therapy with ZYFLO CR can be continued during acute exacerbations of asthma.


See all Zyflo CR indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Zyflo CR (Zileuton)

Inhaled Steroids May Suppress Growth in Children With Asthma
Source: Medscape Today Headlines [2014.07.18]
Inhaled corticosteroids may suppress growth in the first year of treatment in children with asthma, but lower doses may minimize the effects, according to 2 Cochrane reviews.
Medscape Medical News

Asthma medication linked to growth suppression in children
Source: Respiratory / Asthma News From Medical News Today [2014.07.17]
A review of past studies has found that inhaled corticosteroids used to treat asthma could result in restricting the growth of children who have the condition.

Progress in allergic asthma research after ingestion of fruits
Source: Allergy News From Medical News Today [2014.07.16]
Researchers at the UPM suggest that the interaction between two proteins can be the responsible for the allergic asthma episodes after eating an infected fruit.

Active genetic neighborhoods scoured for genes that can be targeted to treat asthmatic disease
Source: Respiratory / Asthma News From Medical News Today [2014.07.10]
In a study published in the scientific journal Nature Immunology, a group at the La Jolla Institute (LJI) led by Pandurangan Vijayanand, Ph.D.

Prediction Update: Asthma
Source: MedPage Today Allergy & Immunology [2014.07.10]
(MedPage Today) -- In January, we asked, "What will be the most important clinical development in asthma in 2014?" Now, at the half-year mark, we return to our experts to ask how their predictions are holding up.

more news >>

Published Studies Related to Zyflo CR (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).

Zileuton added to low-dose inhaled beclomethasone for the treatment of moderate to severe persistent asthma. [2007.06]
OBJECTIVE: To assess the therapeutic effects of oral zileuton tablets combined with low-dose beclomethasone compared to doubling the dose of beclomethasone, in improving lung function and reducing asthma symptoms... CONCLUSIONS: The addition of a 5-LO inhibitor added to low-dose beclomethasone may be an alternative to higher-doses of ICS in patients unable to achieve sufficient asthma control on low-dose ICS therapy.

The safety and efficacy of zileuton controlled-release tablets as adjunctive therapy to usual care in the treatment of moderate persistent asthma: a 6-month randomized controlled study. [2007.05]
This study was conducted to assess the safety and efficacy of zileuton controlled release [CR] 1,200 mg BID added to usual care (UC) in 926 patients with moderate asthma (619 patients randomized to zileuton CR and 307 to placebo). Sustained improvements in AM and PM peak expiratory flow (PEF) were observed in the zileuton CR group compared to placebo.

more studies >>

Clinical Trials Related to Zyflo CR (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.

Evaluation of Rosiglitazone Anti-inflammatory Effect With FDG-PET Imaging [Recruiting]
The purpose of this research study is to gain understanding of the basic responses of the lung to inflammation and specifically if a certain medication can reduce the inflammation alone or in combination with another. Inflammation is the way our bodies react to irritation or injury, and involves red, warm, and often painful swelling of the affected tissue. "Acute lung injury" involves inflammation that is not specific to one area of the lung and is caused by any one of several conditions: infection, trauma, breathing toxic substances, etc. When lung injury is severe, not enough oxygen can get into the body; this can lead to the need for mechanical support of breathing (mechanical ventilation), problems with brain, heart or other organ function, and in some cases, death.

Modulation of Arachidonic Acid Metabolism by Chemopreventive Agents in Smokers [Recruiting]
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.

Zileuton to Treat Adults With Chronic Obstructive Pulmonary Disease (The LEUKO Study) [Recruiting]
Chronic obstructive pulmonary disease (COPD) is a long-term lung disease that is caused by cigarette smoking or by breathing in other lung irritants, including pollution, dust, or chemicals. The purpose of this study is to evaluate the effectiveness of zileuton, a medication that is used to control asthma symptoms, at reducing the length of a hospital stay for adults who are hospitalized for a COPD exacerbation, or worsening of COPD symptoms.

more trials >>

Reports of Suspected Zyflo CR (Zileuton) Side Effects

Palpitations (3)Drug Ineffective (2)Death (2)Product Quality Issue (2)Alanine Aminotransferase Increased (2)Aspartate Aminotransferase Increased (2)Blood Bilirubin Increased (1)Hypersensitivity (1)Pyrexia (1)Fatigue (1)more >>


Page last updated: 2014-07-18

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