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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.


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NEWS HIGHLIGHTS

Media Articles Related to Zyflo CR (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.

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Published Studies Related to Zyflo CR (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).

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 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 CR (Zileuton)

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.

PF-04191834 Single Dose Bronchodilatory Study In Asthma. [Recruiting]
Study to determine the bronchodilatory effects of PF-04191834 compared with zileuton in patients with asthma

Pilot Study of a Multi-Drug Regimen for Severe Pulmonary Fibrosis in Hermansky-Pudlak Syndrome [Recruiting]
This study will examine whether five drugs (pravastatin, Losartan, Zileuton, N-acetylcysteine and erythromycin) used together can slow the course of pulmonary fibrosis (scarring of the lung tissue) in patients with Hermansky-Pudlak Syndrome (HPS). Patients with this disease have decreased skin color (albinism), bleeding problems, and sometimes colon problems. Two of the known types of Hermansky Pudlak syndrome, type 1 and type 4, are at high risk of pulmonary fibrosis between the ages of 30 and 50.

Patients 18 to 70 years of age who have Hermansky-Pudlak Syndrome with a serious loss of lung function due to pulmonary fibrosis may be eligible for this study.

Participants begin taking pravastatin on study day 2 and start a new drug every 3 days. Patients who experience no problems with the medicines return home and continue on the drugs for the next 2 years. They return to the NIH Clinical Center every 3 months for a medical history, physical examination, and blood, urine and lung function tests. CT and bone density scans are done every year. The study may continue for up to 3 years.

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Page last updated: 2009-11-19

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