A Randomized, Double-Blind, Parallel Study of the effects on asthma control of a Once Daily Dosing of EPI-12323 versus Placebo in Symptomatic Moderate to Severe Asthmatics on Low-Dose Inhaled Corticosteroids

Epigenesis Pharmaceuticals, LLC, USA0 个研究点目标入组 214 人开始时间: 2007年4月3日最近更新: 2020年1月13日

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•Asthma Diagnosis: Patients must have a documented history of chronic asthma for at least the past one (1) year. Prior Asthma Medications: Documented use for at least 30 days prior to screening of inhaled short-acting beta 2-agonists. At the time of screening patients must be on at least 800 ucg budesonide (or >500 ucg fluticasone/day) for at least 3 months prior to screening or inhaled corticosteroids with a long acting beta-agonist (ICS + LABA) combination with a dose of at least 500 ucg fluticasone or at least 800 ucg of budesonide/day In-clinic FEV1 values must be greater than or equal to 60% of predicted normal following a 6 hour salbutamol withhold or a 12 hour long acting beta-agonist withhold Patients must be non-smokers for at least the past year and have less than a 10 pack-year smoking history. Patients must sign and date an informed consent prior to any study procedures. Patients must be able to complete diariesMales must have a Prostate specific antigen (PSA) <4.0 ng/mL on screening.

•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 Patients must be withdrawn from leukotriene receptor antagonists, 5 Lipoxygenase (LO) inhibitors or methylxanthines for at least two weeks prior to starting this study. Patients must be withdrawn from injectable anti-IgE therapy for at least 6 months prior to randomization.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must withdraw from inhaled methacholine antagonists or cromones for one week prior to screening.Patients must be withdrawn from bisphosphonates and calcitonin for at least 3 months prior to screening.Patients may not be on selective estrogen receptor modifiers (SERMs) ie 'Evista',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.

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Epigenesis Pharmaceuticals, LLC, USA