A Study to Evaluate the Effectiveness and Safety of CNTO6785 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
2016年6月6日 更新者：Janssen Research & Development, LLC
A Randomized, Placebo Controlled Double-Blind, Multi-Center, Phase II Study to Assess the Efficacy and Safety of CNTO6785 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
The purpose of the study is to evaluate the effect of CNTO6785 compared with placebo in participants with moderate to severe Chronic Obstructive Pulmonary Disease.
研究概览
详细说明
This is a multi-center, randomized (study medication is assigned by chance), placebo-controlled (effect of the study medication will be compared with the effect of placebo [inactive substance]), double-blind (neither physician nor participant knows the treatment that the participant receives), parallel-group study (each group of participants will be treated at the same time).
This study consists of 3 phases: a screening phase (within 3 weeks prior to the start of study medication), a treatment phase (12 weeks), and a follow-up phase (12 weeks after the last administration of study medication).
Approximately 170 participants will be enrolled in this study to receive CNTO6785 or placebo in 1:1 ratio.
Safety will be evaluated by the assessment of adverse events, vital signs, 12-lead electrocardiogram, physical examination, early detection of active tuberculosis, and clinical laboratory tests which will be monitored throughout the study.
The total duration of study participation for a participant will be 30 weeks.
研究类型
介入性
注册 (实际的)
187
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Barnaul、俄罗斯联邦
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Ekaterinburg、俄罗斯联邦
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Kemerovo、俄罗斯联邦
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Novosibirsk、俄罗斯联邦
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Saint Petersberg、俄罗斯联邦
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Saint-Petersberg、俄罗斯联邦
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Saratov、俄罗斯联邦
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St. Petersburg、俄罗斯联邦
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Yaroslavl、俄罗斯联邦
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Balassagyarmat、匈牙利
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Budapest、匈牙利
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Farkasgyepü、匈牙利
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Komarom、匈牙利
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Létavértes、匈牙利
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Mohacs、匈牙利
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Nagykanizsa、匈牙利
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Zalaegerszeg-P Zva N/A、匈牙利
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New Taipei City、台湾
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Taipei、台湾
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Seoul、大韩民国
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Suwon、大韩民国
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Wonju-Si、大韩民国
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Berlin、德国
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Dresden、德国
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Frankfurt、德国
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Grosshansdorf、德国
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Hannover、德国
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Koblenz、德国
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Magdeburg、德国
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Ruedersdorf、德国
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Brno、捷克共和国
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Jindrichuv Hradec、捷克共和国
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Karlovy Vary、捷克共和国
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Melnik、捷克共和国
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Praha 5 - Radotin、捷克共和国
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Praha 8、捷克共和国
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Strakonice、捷克共和国
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Krakow、波兰
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Lodz、波兰
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Poznan、波兰
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Poznań、波兰
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Wroclaw、波兰
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Batu Caves、马来西亚
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Kota Bharu、马来西亚
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Kuala Lumpur、马来西亚
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
40年 至 75年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion criteria:
- Moderate to severe Chronic Obstructive Pulmonary Disease (COPD) (Grade II or Grade III according to the GOLD Guidelines) with chronic bronchitis (sputum production on most days for at least 12 weeks per year for at least 2 successive years) at screening
- Persistent COPD symptoms that required repeated (greater than 1) 'as needed' use of a short acting rescue medication within 4 weeks prior to screening
- Had at least 2 COPD exacerbations requiring antibiotics and/or systemic corticosteroids in the past 2 years OR able to spontaneously produce an adequate sputum sample within 3 to 6 weeks prior to the start of study medication
- Be a current or ex-smoker who has a smoking history of at least 10 pack years at screening
- Meet tuberculosis(TB) screening criteria as: no history of latent or active TB, no signs or symptoms suggestive of active TB, have not had recent (within 3 months) close contact with a person with active TB, and no evidence of current, active TB or old, inactive TB
Exclusion criteria:
- Pulmonary disease, such as asthma, clinically significant bronchiectasis, cystic fibrosis, sarcoidosis, interstitial lung disorder, moderate or severe sleep apnea, or pulmonary hypertension at screening
- Has ever experienced life-threatening COPD, had a lung lobectomy, lung cancer surgery, lung volume reduction, or a lung transplant
- Requires oxygen therapy on a daily basis (greater than 12 hours/day) for chronic hypoxemia (inadequate level of oxygen in the blood) at screening
- Has received any live, attenuated viral or bacterial vaccines within 3 months prior to screening or is expected to receive any live attenuated vaccinations during the study or up to 6 months after the last administration of study medication
- Positive serology to human immunodeficiency virus 1 or 2, hepatitis B virus, or hepatitis C virus
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
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安慰剂比较：安慰剂
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Sterile, 5 percent dextrose will be used as the placebo in this study.
Placebo will be administered by intravenous infusion on Weeks 0, 2, 4, 8 and 12.
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实验性的：CNTO 6785
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CNTO 6785 (6 mg/kg) will be administered by intravenous (into a vein) infusion on Weeks 0, 2, 4, 8 and 12. Participants who weigh more than 100 kg will receive a dose of 600 mg of CNTO 6785.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Change from baseline in prebronchodilator (before taking an inhaled bronchodilator) Forced Expiratory Volume in 1 second (FEV1) at Week 16
大体时间：Baseline (Week 0), Week 16
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FEV1 is the amount of air that can be exhaled in one second.
FEV1 will be measured by spirometry.
A positive change from baseline in FEV1 indicates improvement in lung function.
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Baseline (Week 0), Week 16
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Change from baseline in postbronchodilator (after taking an inhaled bronchodilator) Forced Expiratory Volume in 1 second (FEV1) at Week 16
大体时间：Baseline (Week 0), Week 16
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FEV1 is the amount of air that can be exhaled in one second.
FEV1 will be measured by spirometry.
A positive change from baseline in FEV1 indicates improvement in lung function.
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Baseline (Week 0), Week 16
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Change from baseline in weekly average number of occasions in a day that rescue medication is used at Week 16
大体时间：Baseline (Week 0), Week 16
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Rescue medication is a relief medication for chronic obstructive pulmonary disease symptoms.
e.g. when patients feel breathless, chest tight, or frequent cough.
The reduction of number of the occasions indicates disease improvement with less symptoms.
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Baseline (Week 0), Week 16
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Change from baseline in EXAcerbations of Chronic Pulmonary Disease Tool-Respiratory Symptoms™ (E-RS™) at Week 16
大体时间：Baseline (Week 0), Week 16
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E-RS is a 11-item respiratory system scoring algorithm to assess the severity of respiratory symptoms in participants with chronic obstructive pulmonary disease (COPD).
Each item has either 5 or 6 response options.
Higher score indicates more severe COPD.
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Baseline (Week 0), Week 16
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Change from baseline at Week 16 in total score of the St George's respiratory questionnaire for Chronic Obstructive Pulmonary Disease (COPD) participants (SGRQ-C)
大体时间：Baseline (Week 0), Week 16
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SGRQ-C is a 40-item questionnaire designed to measure health impairment in participants with COPD.
SGRQ-C is divided into two components: 1) symptoms, 2) activity& impacts.
Total SGRQ-C score ranges from 0 (best) and 100 (worst).
Higher scores indicate greater health impairment.
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Baseline (Week 0), Week 16
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2013年11月1日
初级完成 (实际的)
2015年9月1日
研究完成 (实际的)
2015年9月1日
研究注册日期
首次提交
2013年10月17日
首先提交符合 QC 标准的
2013年10月17日
首次发布 (估计)
2013年10月21日
研究记录更新
最后更新发布 (估计)
2016年6月8日
上次提交的符合 QC 标准的更新
2016年6月6日
最后验证
2016年6月1日
更多信息
与本研究相关的术语
其他研究编号
- CR102318
- CNTO6785OPD2001 (其他标识符：Janssen Research & Development, LLC)
- 2012-003607-36 (EudraCT编号)
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.