EPI-12323 for the treatment of symptomatic moderate to severe asthma

Exclusion Criteria1

• In-clinic FEV1 <60% of predicted normalHistory of life-threatening asthma No use of injectable or oral corticosteroids within 3 months prior to screening. Patients must be withdrawn from leukotriene receptor antagonists, 5 Lipoxygenase (LO) inhibitors or methylxanthines for at least two weeks prior to starting this study. Patients must be withdrawn from injectable anti-IgE therapy for at least 6 months prior to randomization. Patients must withdraw from inhaled methacholine antagonists or cromones for one week prior to screening.Patients must be withdrawn from bisphosphonates and calcitonin for at least 3 months prior to screening.Patients may not be on selective estrogen receptor modifiers (SERMs) ie 'Evista', for at least one month prior to screening Previous participation in an investigational drug trial within 30 days of Screening.Only one member of the immediate household may participate in the trial. Pregnant or lactating femalesPatients with a serious concomitant disease such as cancer or serious renal, hepatic, cardiac, immunodeficiency, neurological, psychiatric, or other disease;Patients who have had an upper respiratory tract infection within 4 weeks of screening;Other protocol defined exclusions apply.