An Open-Label Extension Study to evaluate the Long-Term Safety and Efficacy of Reslizumab (3.0 mg/kg) as Treatment for Patients with Eosinophilic Asthma who completed a prior Cephalon-sponsored Study in Eosinophilic Asthma

Cephalon Inc.0 个研究点目标入组 740 人开始时间: 2011年5月10日最近更新: 2015年7月10日

适应症

试验速览

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•Patients are included in the study if all of the following criteria are met:
•(a) The patient is male or female, 12 through 75 years of age, with a previous diagnosis of asthma and who completed treatment in a Cephalon sponsored, double-blind, placebo-controlled study in patients with eosinophilic asthma.
•(b) Written informed consent is obtained. Patients 12 through 17 years old need to provide assent in accordance with local standards.
•(c) Patient must have completed treatment in a previous double-blind asthma exacerbation study or received at least 2 doses of study drug treatment in a pulmonary function study.
•(d) The patient must be willing and able to comply with study restrictions and to remain at the clinic for the required duration during the study period, and willing to return to the clinic for the follow-up evaluation as specified in this protocol.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 74
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 555
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 111

•Patients are excluded from participating in this study if 1 or more of the following criteria are met:
•(a) The patient has a clinically meaningful comorbidity that would interfere with the study schedule or procedures, or compromise the patient’s safety.
•(b) The patient has another confounding underlying lung disorder (eg, chronic obstructive pulmonary disease, pulmonary fibrosis, or lung cancer).
•(c) The patient is a current smoker.
•(d) The patient is expected to be poorly compliant with study drug administration, study procedures, or visits.
•(e) The patient has any aggravating factors that are inadequately controlled (eg, gastroesophageal reflux disease [GERD]).
•(f) Female patients who are pregnant, or nursing, or, if of childbearing potential and not using a medically accepted, effective method of birth control (eg, spermicide, abstinence, intrauterine device (IUD), or steroidal contraceptive [oral, transdermal, implanted, and injected] in conjunction with a barrier method) are excluded from this study.
•(g) The patient has a current infection or disease that may preclude assessment of asthma.

发起方