A Prospective, Single Site, Randomized, Controlled, Parallel Group Study in Subjects With Chronic Obstructive Pulmonary Disease (COPD) Stage III and IV Using AlphaCore or Sham (Control, Not Active) as a Prophylactic Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Chronic Obstructive Pulmonary Disease Assessment Test (CAT) Scores (Quality of Life and Symptoms) Changes Within a Treatment Period and Comparison Between the Two Groups
研究概览
简要总结
The study will assess the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD) stage III and IV who will self administer the AlphaCore stimulation three times a day over a course of 2 months. Patients will either receive an active AlphaCore device or a Sham device during these two months while not knowing which device they have been provided. At the end of the two months, all patients will be asked to continue in the study for another 2 months to self administer with the active AlphaCore device. Subjects will complete diaries at home on their breathing and quality of life and will return to the clinic monthly for assessment by the investigator.
详细描述
PERFORMANCE AND SAFETY VARIABLES:
The primary efficacy endpoint for this study is the total Chronic obstructive pulmonary disease (COPD) Assessment Test (CAT) score change from baseline to the 8 week follow-up period comparing the two device groups.
Secondary efficacy endpoints will be the mean difference from baseline to the 8 week follow-up for the following assessments: Medical Research Council (MRC) dyspnoea scale, 6 minutes walking test and Forced Expiratory Volume in one second (FEV1)
Safety Variables:
Each subject will be assessed throughout the study for Adverse Events and at the last visit (4 months) subjects will undergo another physical examination including vital signs and blood pressure.
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
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40-75 years
- •Diagnosed Chronic obstructive pulmonary disease(COPD) stage III and IV according to Global Initiative for chronic obstructive lung disease (GOLD) guideline
- •Forced expiratory volume in one second (FEV 1) < 50%
- •Forced expiratory volume in one second (FEV1/Forced expiratory vital capacity (FVC) < 70%
- •Signed informed consent form
排除标准
- •Participation in other clinical trials (drug or medical device) 30 days prior to start of this study
- •Subject is unable to comply with the procedures if the protocol for the study or any other reason judged by the Investigator that could interfere with the study assessment or follow-up
- •Has an abscess or other infection or lesion (including lymphadenopathy) at the AlphaCore® treatment site.
- •Is currently implanted with an electrical and/or neurostimulator device, including but not limited to cardiac pacemaker, defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, or cochlear implant.
- •Has a history of carotid endarterectomy or vascular neck surgery on the right side.
- •Right side or bilateral vagotomy
- •Has a recent or repeated history of syncope.
- •Has a recent or repeated history of seizures.
- •Pregnant or breast feeding women
结局指标
主要结局
Chronic Obstructive Pulmonary Disease Assessment Test (CAT) Scores (Quality of Life and Symptoms) Changes Within a Treatment Period and Comparison Between the Two Groups
时间窗: 8 weeks
Chronic obstructive pulmonary disease Assessment Test (CAT) scores (Quality of life and symptoms) changes within a treatment period and comparison between the two groups. Eight (8) questions. The scale is rated from 0 to 5, min = 0, max = 5. Low rates = better, high rates = worse. Mean change in the period 8 weeks versus baseline.
次要结局
- Change in Forced Expiratory Volume (FEV1)(Baseline vs 8 weeks)
- Number of Subjects With Adverse Events (AE)(Throughout the course of the study (baseline to the 4 month follow-up visit))
- Change 6 Minutes Walking Test(Baseline vs 8 weeks)
- Change in Borg Dyspnoea Scores(Baseline vs 8 weeks)
- Change in Change in EuroQol, 5 Questions and 3 Levels (EQ-5D-3L), Visual Analogue Scale (VAS)(Baseline vs 8 weeks)
- Change in EuroQol, 5 Questions and 3 Levels (EQ5D-3L)(Baseline vs 8 weeks)