BACE Trial Substudy 1 - PROactive Substudy (PROactive)
BACE Trial - Physical Activity as a Crucial Patient Reported Outcome in COPD
研究概览
详细说明
Physical activity is strongly reduced with exacerbations and failure to increase physical activity is associated with relapse. In addition, physical inactivity is known to be associated with cardiovascular and metabolic morbidity and is one of the strongest predictors of mortality in COPD. Apart from potential direct effects of the intervention on treatment failure and symptoms, positive effects on physical activity may offer considerable benefits in the long run.
Randomized patients that are willing to participate in the sub-study will be monitored for activity by validated and easy-to-wear portable devices (Dynaport®). This activity monitor was recently thoroughly validated for use in COPD by the Pro-Active consortium and will be used at the baseline, 3 months and 9 months visit. We hypothesize that with a positive medical intervention, differences in recovery of physical activity will be appreciated.
Patients will follow the standard protocol but will also wear the activity monitor for 7 days post discharge from hospital (at investigator discretion), at day 90 (end of treatment) and at day 270 (end of follow-up). This device is not only registering physical activity for 7 days but is also coupled to a standardized and patient-validated questionnaire on physical activities which needs to be filled out at day 8 to cover a recall period of 7 (monitored) days.
Patient will have to give informed consent for the additional measures that are related to the activity sub-study. However, individual patients can still opt out for these tests (sub-study) and only participate in the medical intervention study (main study).
研究类型
注册 (预期的)
阶段
- 第三阶段
联系人和位置
学习地点
-
-
Brussels Hoofdstedelijk Gewest
-
Brussel、Brussels Hoofdstedelijk Gewest、比利时、1000
- St. Pieterziekenhuis
-
-
Vlaanderen
-
Antwerpen、Vlaanderen、比利时、2020
- ZNA Middelheim
-
Bonheiden、Vlaanderen、比利时、2820
- Imelda Ziekenhuis
-
Gent、Vlaanderen、比利时、9000
- UZ Gent
-
Hasselt、Vlaanderen、比利时、3500
- Jessa Ziekenhuis
-
Leuven、Vlaanderen、比利时、3000
- UZ Gasthuisberg
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Established diagnosis of COPD by medical doctor (based on clinical history OR pulmonary function test)
- Smoking history of at least 10 pack-years (10 pack-years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years, etc.)
- Current hospitalization for potential infectious AECOPD treated with standard therapy
- History of at least one exacerbation during the last year (prior to the current hospital admission) for which systemic steroids and/or antibiotics were taken
- ECG at admission
Exclusion Criteria:
- Mechanical or non-invasive ventilation at moment of randomization (D1)
- Long QT interval on ECG (QTc > 450msec for males or > 470msec for females)
- History of life-threatening arrhythmias
- Myocardial infarction (NSTEMI or STEMI) less than 6 weeks before start of study drug
- Unstable angina pectoris or acute myocardial infarction (NSTEMI or STEMI) at admission
- Drugs with high risk for long QT interval and torsade de pointes (amiodarone, flecainide, procainamide, sotalol, droperidol, haldol, citalopram, other macrolides)
- Documented uncorrected severe hypokalemia (K+ < 3.0 mmol/L) or hypomagnesemia (Mg2+ < 0.5 mmol/L)
- Chronic systemic steroids (> 4 mg methylprednisolone /day for ≥ 2 months)
- Actual use of macrolides for at least 2 weeks
- Allergy to macrolides
- Active cancer treatment
- Life expectancy < 3 months
- Pregnant or breast-feeding subjects. Woman of childbearing potential must have a pregnancy test performed and a negative result must be documented before start of treatment
学习计划
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：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Azithromycin
N = 250 From day 1 up to and including day 3: 500 mg azithromycin PO once a day From day 4 up to and including day 90: 250 mg azithromycin PO once every 2 days N= 30 During 7 days post discharge from hospital (0 months), 3 months and 9 months, the patient will wear the Dynaport® which will register the patient's physical activity |
从第 1 天到第 3 天（包括第 3 天）：每天一次 500 mg 阿奇霉素或安慰剂 PO 从第 4 天到第 90 天（包括第 90 天）：每 2 天一次 250 mg 阿奇霉素或安慰剂 PO
其他名称：
Registering physical activity during 7 days post discharge from hospital (0 months), 3 months and 9 months
其他名称：
|
|
安慰剂比较：Placebo
N = 250 From day 1 up to and including day 3: 500 mg placebo PO once a day From day 4 up to and including day 90: 250 mg placebo PO once every 2 days N= 30 During 7 days post discharge from hospital (0 months), 3 months and 9 months, the patient will wear the Dynaport® which will register the patient's physical activity |
其他名称：
Registering physical activity during 7 days post discharge from hospital (0 months), 3 months and 9 months
其他名称：
|
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 |
|---|---|---|
|
Difference in Physical Activity (total amount of steps) registered by the Dynaport® during 7 days between discharge from hospital (0 months) and 3 months after randomisation
大体时间：At discharge from hospital (0 months) and 3 months after start study drug intake
|
Physical activity will be quantified as Total amount of steps
|
At discharge from hospital (0 months) and 3 months after start study drug intake
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Key secondary endpoint: Different change in physical activity (total amount of steps) at 3 months between placebo and azithromycin arm
大体时间：0 and 3 months
|
Difference between placebo and azithromycin arm in physical activity changes registered by the Dynaport® during 7 days at discharge from hospital (0 months) and at 3 months
|
0 and 3 months
|
|
Different change in physical activity (total amount of steps) at 9 months between placebo and azithromycin arm
大体时间：at baseline and 9 months
|
Difference between placebo and azithromycin arm in physical activity changes registered by the Dynaport® during 7 days at discharge from hospital (0 months) and at 9 months
|
at baseline and 9 months
|
|
Difference in Physical Activity (TSMVA) registered by the Dynaport® during 7 days between discharge from hospital (0 months) and 9 months, or between 3 months and 9 months after randomisation
大体时间：baseline, 3 and 9 months
|
Physical activity will be specified for:
|
baseline, 3 and 9 months
|
|
Difference in Physical Activity (TSMVA) registered by the Dynaport® during 7 days between discharge from hospital (0 months) and 3 months after randomisation
大体时间：At discharge from hospital (0 months) and 3 months after start study drug intake
|
Physical activity will be specified for:
|
At discharge from hospital (0 months) and 3 months after start study drug intake
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Exploratory endpoint: sensitivity analysis of primary and secondary endpoints in subgroups
大体时间：at 0, 3 and 9 months
|
|
at 0, 3 and 9 months
|
合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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.
安慰剂的临床试验
-
City of Hope Medical CenterNational Cancer Institute (NCI)主动，不招人造血和淋巴细胞肿瘤 | 骨髓纤维化 | 慢性淋巴细胞白血病 | 缓解期成人急性髓性白血病 | 骨髓增生异常综合症 | 缓解期成人急性淋巴细胞白血病 | 骨髓增殖性肿瘤 | 慢性期慢性粒细胞白血病，BCR-ABL1 阳性 | 成人淋巴母细胞淋巴瘤 | 加速期慢性粒细胞白血病，BCR-ABL1 阳性 | HLA-A*0201 阳性细胞存在 | 巨细胞病毒感染 | 成人霍奇金淋巴瘤 | 成人非霍奇金淋巴瘤美国
-
Mila (bMotion Technologies)完全的
-
Universidad Autonoma de MadridCentro Universitario La Salle完全的