NCT01270464已完成3 期
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
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 315
- 试验地点
- 89
- 主要终点
- Change From Baseline In Forced Expiratory Volume In 1 Second (FEV1) Over 16 Weeks Using Mixed Model for Repeated Measures
研究概览
简要总结
The primary objective of this study is to determine whether reslizumab, at a dosage of 0.3 or 3.0 mg/kg administered once every 4 weeks for a total of 4 doses, is more effective than placebo in improving lung function in patients with eosinophilic asthma as assessed by the overall change from baseline in forced expiratory volume in 1 second (FEV1).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 12 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is 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 Argentina.
- •The patient has an ACQ score of at least 1.
- •The patient has airway reversibility of at least 12% to beta-agonist administration at screening.
- •The patient is currently taking fluticasone at a dosage of at least 440 μg daily (or equivalent). Patients' baseline asthma therapy regimens (including but not limited to inhaled corticosteroids, leukotriene antagonists, 5-lipoxygenase inhibitors, cromolyn) must be stable for 30 days before screening, and continue without dosage changes throughout study.
- •The patient has a blood eosinophil count of at least 400/μL.
- •Female patients must be surgically sterile, 2 years postmenopausal, or must have a negative pregnancy test ßHCG at screening (serum) and baseline (urine).
- •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).
- •Written informed consent is obtained. Patients 12 through 17 years old, where participating, need to provide assent in accordance with local standards.
- •Other inclusion criteria apply.
排除标准
- •The patient has a clinically meaningful comorbidity that would interfere with the study schedule or procedures, or compromise the patient's safety.
- •The patient has known hypereosinophilic syndrome (HES).
- •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 aspergillosis).
- •The patient is a current smoker (ie, has smoked within the last 6 months prior to screening).
- •The patient has a history of use of systemic immunosuppressive or immunomodulating agents (anti-IgE mAb, methotrexate, cyclosporin, interferon-α, or anti-tumor necrosis factor mAb) within 6 months prior to study entry (screening).
- •The patient is currently using systemic corticosteroids (includes use of oral corticosteroids).
- •The patient has a current infection or disease that may preclude assessment of asthma.
- •The patient is expected to be poorly compliant with study drug administration, study procedures, or visits.
- •The patient has any aggravating factors that are inadequately controlled (eg, gastroesophageal reflux disease).
- •The patient has participated in any investigative drug or device study within 30 days prior to screening.
- •The patient has participated in any investigative biologics study within 90 days prior to screening.
- •The patient has previously received anti-hIL-5 monoclonal antibody (eg, mepolizumab).
- •Female patients who are pregnant, or nursing, or, if of childbearing potential and not using a medically accepted, effective method of birth control (e.g. spermicide, abstinence, IUD, or steroidal contraceptive [oral, transdermal, implanted, and injected]) are excluded from this study.
- •The patient has a current infection or disease that may preclude assessment of asthma.
- •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.
- •Other exclusion criteria apply.
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
干预措施: Placebo (Drug)
Reslizumab - 0.3 mg/kg
Experimental
0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
干预措施: Reslizumab (Drug)
Reslizumab - 3.0 mg/kg
Experimental
3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
干预措施: Reslizumab (Drug)
结局指标
主要结局
Change From Baseline In Forced Expiratory Volume In 1 Second (FEV1) Over 16 Weeks Using Mixed Model for Repeated Measures
时间窗: Day 0 (baseline, pre-dose), Weeks 4, 8, 12 and 16
FEV1 is a standard measurement of air movement in the lungs of patients with asthma obtained from pulmonary function tests. It is the volume of air expired in the first second of a forced expiration using a spirometer. The during treatment (weeks 4, 8, 12 and 16) average FEV1 was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements. Positive change from baseline scores indicate improvement in asthma control.
次要结局
- Change From Baseline in Forced Vital Capacity (FVC) Over 16 Weeks Using Mixed Model for Repeated Measures(Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16)
- Change From Baseline in Forced Expiratory Flow at 25% to 75% Forced Vital Capacity (FEF 25%-75%) Over 16 Weeks Using Mixed Model for Repeated Measures(Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16)
- Change From Baseline in Asthma Symptom Utility Index (ASUI) Over 16 Weeks Using Mixed Model for Repeated Measures(Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16)
- Participants With Adverse Events(Day 1 (post-dose) to Week 29)
- Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Abnormal Lab Values(Day 2 to Week 29)
- Change From Baseline in % Predicted Expiratory Volume In 1 Second (FEV1) at Week 16 and at Endpoint(Day 1 (baseline, pre-dose), Week 16, endpoint)
- Change From Baseline in Asthma Control Questionnaire (ACQ) Over 16 Weeks Using Mixed Model for Repeated Measures(Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16)
- Change From Baseline in Short-Acting Beta-Agonist (SABA) Use Over 16 Weeks Using Mixed Model for Repeated Measures(Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16)
- Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) at Week 16 or at Last Observed Value(Day 1 (baseline, pre-dose), Week 16 or last observed value)
- Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Vital Signs Values(Day 2 to Week 29)
- Change From Baseline in Blood Eosinophil Count Over 16 Weeks Using Mixed Model for Repeated Measures(Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16)
- Participants With a Positive Anti-Reslizumab Antibody Status at Baseline, Week 8, Week 16, Endpoint, and Overall(Day 1 (pre-dose), week 8, 16 and endpoint)
- Shifts From Baseline to Endpoint in Electrocardiogram Findings(Weeks -4 to -2 (Screening Visit), Week 16)
研究者
研究点 (89)
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