Zileuton CR vs Placebo in Poorly Controlled Asthma Patients on Moderate Dose ICS
Status:
Terminated
Trial end date:
2008-06-01
Target enrollment:
Participant gender:
Summary
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.