A Randomized, Double-blind, Placebo Controlled, Exploratory Study to Assess the Safety and Efficacy of Multiple Doses of ACZ885 in Chronic Obstructive Pulmonary Disease (COPD) Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 147
- 试验地点
- 1
- 主要终点
- Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
研究概览
简要总结
Was to evaluate the safety, tolerability and efficacy of multiple doses of canakinumab (ACZ885) vs. placebo when administered via intravenous infusion (IV), on pulmonary function in patients with COPD
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and/or female subjects from 40-80 years (inclusive) of age
- •Subjects have a clinical diagnosis of COPD
- •Smokers or Ex-smokers with a smoking history of at least 20 pack years
- •Post-bronchodilator forced expiratory volume in 1 second (FEV1 ) at screening ≤ 50% of the predicted normal value
- •Post-bronchodilator FEV1/FVC ratio < 70%
- •History of at least one treated exacerbation during the 24 months year prior to screening or C-Reactive Protein (CRP) ≥3.47 mg/L,
- •Subjects should have no concomitant other lung disease or significant concomitant medical conditions that would affect the subjects' safety when participating in the study, or that would be expected to impact on the results of the study
- •Female subjects must have been surgically sterilized at least 6 months prior to screening or must be using two forms of contraception, or postmenopausal women
- •Able to provide written informed consent prior to study participation.
- •Able to communicate well with the investigator and comply with the requirements of the study.
排除标准
- •COPD exacerbation(s) requiring treatment within 4 weeks prior to first dosing
- •History of lung reduction surgery
- •Any undiagnosed nodule on chest x-ray
- •Presence of certain medical conditions as specified by the protocol
- •Subjects requiring oral or parenteral corticosteroids equivalent to > 10 mg/day or > 20 mg every other day of prednisone or prednisolone
- •Documented homozygous alpha-1 antitrypsin deficiency.
- •Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation.
- •Donation or loss of 400 mL or more of blood within 8 weeks prior to dosing.
- •A past medical history of clinically significant electrocardiogram (ECG) abnormalities or a family history of a prolonged QT-interval syndrome.
- •A known hypersensitivity to drugs similar to the study drug.
- •History of immunocompromise, including a positive HIV test result.
- •A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
- •History of drug or alcohol abuse within the 12 months prior to screening or evidence of such abuse as indicated by the laboratory assays conducted during screening.
研究组 & 干预措施
Canakinumab
Participants received an initial dose of 1 mg/kg canakinumab (ACZ885) via intravenous infusion. Four weeks later, participants received a dose of 3 mg/kg canakinumab, and another dose of 3 mg/kg two weeks later. Thereafter, participants received doses of 6 mg/kg every four weeks until completion of the 45-week treatment period.
干预措施: Canakinumab (Drug)
Placebo
Participants received a matching placebo intravenous infusion at weeks 1, 5, 7, and thereafter every four weeks until completion of the 45-week treatment period.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
时间窗: Baseline, Week 25 and Week 45
Forced expiratory volume in 1 second (FEV1) is the amount of air that can be exhaled in one second. FEV1 was measured by spirometry performed at approximately the same time of day on each visit to avoid diurnal variation. All spirometry calibrations and evaluations followed the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability. A positive change from baseline in FEV1 indicates improvement in lung function.
Change From Baseline in Forced Expiratory Volume in 1 Second Percent Predicted
时间窗: Baseline, Week 25 and Week 45
The FEV1 percent predicted expresses FEV1 as a percentage of the "predicted values" for participants of similar characteristics (height, age, sex, and sometimes race and weight). A positive change from baseline in FEV1 % predicted indicates improvement in lung function.
Change From Baseline in Forced Vital Capacity (FVC)
时间窗: Baseline, Week 25 and Week 45
Forced Vital Capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed by spirometry. A positive change from baseline in FVC indicates improvement in lung function.
Change From Baseline in Slow Vital Capacity (SVC)
时间窗: Baseline, Week 25 and Week 45
Vital Capacity is the amount of air that can be forcibly exhaled from the lungs after a full inhalation. Slow Vital Capacity (SVC) test is performed by having the patient slowly and completely blow out all of the air from their lungs. A positive change from baseline in SVC indicates improvement in lung function.
Change From Baseline in Forced Expiratory Flow 25% to 75%
时间窗: Baseline, Week 25 and Week 45
The forced expiratory flow (FEF) 25%-75% measurement describes the amount of air expelled from the lungs during the middle half (25% - 75%) of the forced vital capacity test and is measured using spirometry. A positive change from baseline in FEF indicates improvement in lung function.
次要结局
- Number of Participants Who Experienced Serious Adverse Events or Discontinued Due to Adverse Events(Adverse events were collected during the 45 week treatment period and the 12 week follow-up period.)