EUCTR2010-023342-67-SE进行中（未招募）不适用
A 16-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Reslizumab (0.3 or 3.0 mg/kg) as Treatment for Patients (12-75 Years of Age) with Eosinophilic Asthma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients are included in the study if all of the following criteria are met:
- •(a) Inclusion criterion (a) is replaced by (a1).
- •(a1) The patient is a male or female 12 through 75 years of age with a previous diagnosis of asthma. Patients 12 through 17 years of age are excluded from participating in India and Argentina; patients 66 through 75 years of age are excluded from participating in India.
- •(b) The patient has an ACQ score of at least 1.5.
- •(c) The patient has airway reversibility of at least 12% to beta-agonist administration at screening.
- •(d) Inclusion criteria (d ) is replaced by (d1).
- •(d1) The patient is currently taking fluticasone at a dosage of at least 440 µg daily (or equivalent). Patients’ baseline asthma therapy regimen (including but not limited to inhaled corticosteroids, leukotriene antagonists, 5-lipooxegnase inhibitors, cromolyn) must be stable for 30 days before screening, and continue without dosage changes throughout the study.
- •(e) The patient has a blood eosinophil count of at least 400/?L.
- •(f) Female patients must be surgically sterile, 2 years postmenopausal, or must have a negative pregnancy test beta-human chorionic gonadotropin (ßHCG) at screening (serum) and baseline (urine).
- •(g) Inclusion criterion (g) is replaced by (g1).
- •(g1) Female patients of childbearing potential (not surgically sterile or 2 years postmenopausal), must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after the end-of-treatment visit. Acceptable methods of contraception include barrier method with spermicide, abstinence, intrauterine device (IUD), or steroidal contraceptive (oral, transdermal, implanted, and injected).
- •(h) Inclusion criterion (h) is replaced by (h1).
- •(h1) Written informed consent is obtained. Patients 12 through 17 years old, where participating, need to provide assent in accordance with local standards.
- •(i) The patient is in reasonable health (except for diagnosis of asthma) as judged by the investigator, and as determined by a medical history, medical examination, ECG evaluation, serum chemistry, hematology, urinalysis, and serology.
- •(j) 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: 18
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 135
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 27
排除标准
- •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 known HES.
- •(c) Exclusion criteria (c) is replaced by (c1).
- •(c1) The patient has another confounding underlying lung disorder (eg, chronic obstructive pulmonary disease, pulmonary fibrosis, or lung cancer). The patient has other pulmonary conditions with symptoms of asthma and blood eosinophilia (eg, Churg-Strauss syndrome, allergic bronchopulmonary aspergilosis).
- •(d) The patient is a current smoker (ie, has smoked within the last 6 months prior to screening).
- •(e) The patient has a history of use of systemic immunosuppressive or immunomodulating agents (anti-IgE mAb, methotrexate, cyclosporin, interferon-a, or anti-tumor necrosis factor mAb) within 6 months prior to study entry (randomization).
- •(f) The patient is currently using systemic corticosteroids (includes use of oral corticosteroids).
- •(g) The patient is expected to be poorly compliant with study drug administration, study procedures, or visits.
- •(h) The patient has any aggravating factors that are inadequately controlled (eg, gastroesophageal reflux disease).
- •(i) The patient has participated in any investigative drug or device study within 30 days prior to screening.
- •(j) The patient has participated in any investigative biologics study within 90 days prior to screening.
- •(k) The patient has previously received anti-hIL-5 monoclonal antibody (eg, mepolizumab).
- •(l) Exclusion criterion (l) is replaced by (l1).
- •(l1) 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, IUD, or steroidal contraceptive [oral, transdermal, implanted, and injected]) are excluded from this study.
- •(m) The patient has a current infection or disease that may preclude assessment of asthma.
- •(n) Exclusion criterion (n) is replaced by (n1)
- •(n1) The patient has a history of concurrent immunodeficiency (human immunodeficiency, acquired immunodeficiency syndrome, or congenital immunodeficiency). Patients in Argentina must have documented serology testing for HIV performed during screening.
- •(o) The patient has current suspected drug or alcohol abuse as specified in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria.
- •(p) The patient has presence of or suspected parasitic infestation/infection.
- •(q) Patients may not have received any live attenuated vaccine within the 12-week period before screening.
- •(r) The patient has a history of allergic reactions to or hypersensitivity to any component of the study drug.
研究者
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