Media Articles Related to Zyflo CR (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 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
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.
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.
Reports of Suspected Zyflo CR (Zileuton) Side Effects
Drug Ineffective (2),
Product Quality Issue (2),
Alanine Aminotransferase Increased (2),
Aspartate Aminotransferase Increased (2),
Blood Bilirubin Increased (1),
Fatigue (1), more >>