EUCTR2010-021723-27-BG进行中（未招募）不适用
An exploratory, randomized, double-blind, placebo controlled, multi-center study to assess the efficacy, safety and tolerability of a single and a repeated dose of oralBCT197 in patients with an acute COPD exacerbation - Safety & Efficacy of BCT197A2201 in COPD patients presenting with an exacerbation
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 181
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
- •1. Written informed consent must be obtained before any study related assessment is performed.
- •2. Males/females age = 40 to = 80 years
- •3. COPD diagnosed according to Global Initiative for Chronic Obstructive Lung Disease (GOLD 2009) as Stage II to IV and patient presenting with a COPD exacerbation
- •4. Smoking history of at least 10 pack years
- •5. Females must NOT be of child bearing potential (post-menopausal [according to protocol definition] or surgically sterilized). All female patients must have a negative pregnancy test result before randomization.
- •6. Be able to communicate well with the investigator, be able to understand and comply with the requirements of the study, and be able to perform acceptable spirometry.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 120
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 61
- •1. Written informed consent must be obtained before any study related assessment is performed.
- •2. Males/females age = 40 to = 80 years
- •3. COPD diagnosed according to Global Initiative for Chronic Obstructive Lung Disease (GOLD 2009) as Stage II to IV and patient presenting with a COPD exacerbation
- •4. Smoking history of at least 10 pack years
- •5. Females must NOT be of child bearing potential (post-menopausal [according to protocol definition] or surgically sterilized). All female patients must have a negative pregnancy test result before randomization.
- •6. Be able to communicate well with the investigator, be able to understand and comply with the requirements of the study, and be able to perform acceptable spirometry.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 120
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 61
排除标准
- •1.Use of any oral or iv corticosteroids within 30 days of randomization
- •2.Use of any calcium channel blockers within 48 hours of randomization
- •3.Use of macrolide containing antibiotics within 48 hours of randomization
- •4.Arterial blood pH <7.26 at randomization
- •5.History or presence of clinically significant uncontrolled left ventricular failure
- •6.Clinical or radiological evidence of pneumonia
- •7.Elevated liver enzymes (1.5 x ULN) at entry to the study, or history of liver toxicity with other drugs. If patients have a history of liver disease or liver injury as indicated by abnormal liver function tests, then the Investigator should be guided by the following criteria in such cases:
- •a.ALT will have to be strictly within the normal range before inclusion.
- •b.?-GT, AST and alkaline phosphatase must not exceed twice the upper limit of normal
- •8.Participation in any ongoing clinical investigation within four (4) weeks prior to initial dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations
- •9.Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer; or longer if required by local regulations, and for any other limitation of participation in an investigational trial based on local regulations.
- •10.History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
- •11.History of clinically significant ECG abnormalities.
- •12.History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
- •13.Pregnant or nursing (lactating) women.
- •14.Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study. The Investigator should make this determination in consideration of the subject’s medical history and/or clinical or laboratory evidence of any of the following:
- •Inflammatory bowel disease, ulcers, gastrointestinal or rectal bleeding
- •Major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection
- •Pancreatic injury or pancreatitis •Tuberculosis •Dermatitis •Long term oxygen therapy ( > 15 hours a day)
- •15.History or presence of impaired renal function as indicated by clinically significantly abnormal creatinine or BUN and/or urea values, or abnormal urinary constituents (e.g., albuminuria) as judged clinically significant by the attending physician.
- •16.History of immunodeficiency diseases.
- •17.History of Hepatitis B or C.
- •18.History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted at baseline.
- •19.Fertile males defined as all males physiologically capable of conceiving offspring UNLESS the patient agrees to one of the criteria below (for 10 days following study drug administration i.e.: for Days 1 to 10 inclusive in Part I & II, and for Days 1 to 20 inclusive in Parts III and IV)
- •a) Use two highly effective contraceptive methods comprising a barrier method (condom or occlusive cap) plus spermicide, if sexually active
- •b) To be abstemious
- •1.Use of any oral or iv corticosteroids within 30 days of randomization
- •2.Use of any calcium channel blockers within 48 hours of randomization
- •3.Use of macrolide containing antibiotics within 48 hours of randomization
- •4.Arterial blood pH <7.26 at randomization
- •5.History or presence of clinically significant uncontrolled left ventricular failure
- •6.Clinical or radiological evidence of pneumonia
- •7.Elevated liver enzymes (1.5 x ULN) at entry to the study, or history of liver toxicity with other drugs. If patients have a history of liver disease or liver injury as indicated by abnormal liver function tests, then the Investigator should be guided by the following criteria in such cases:
- •a.ALT will have to be strictly within the normal range before inclusion.
- •b.?-GT, AST and alkaline phosphatase must not exceed twice the upper limit of normal
- •8.Participation in any ongoing clinical investigation within four (4) weeks prior to initial dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations
- •9.Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer; or longer if required by local regulations, and for any other limitation of participation in an investigational trial based on local regulations.
- •10.History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
- •11.History of clinically significant ECG abnormalities.
- •12.History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
- •13.Pregnant or nursing (lactating) women.
- •14.Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study. The Investigator should make this determination in consideration of the subject’s medical history and/or clinical or laboratory evidence of any of the following:
- •Inflammatory bowel disease, ulcers, gastrointestinal or rectal bleeding
- •Major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection
- •Pancreatic injury or pancreatitis •Tuberculosis •Dermatitis •Long term oxygen therapy ( > 15 hours a day)
- •15.History or presence of impaired renal function as indicated by clinically significantly abnormal creatinine or BUN and/or urea values, or abnormal urinary constituents (e.g., albuminuria) as judged clinically significant by the attending physician.
- •16.History of immunodeficiency diseases.
- •17.History of Hepatitis B or C.
- •18.History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted at baseline.
- •19.Fertile males defined as all males physiologically capable of conceiving offspring UNLESS the patient agrees to one of the criteria below (for 10 days following study drug administration i.e.: for Days 1 to 10 inclusive in Part I & II, and for Days 1 to 20 inclusive in Parts III and IV)
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