A Randomized, Sham-controlled, Double-blinded Pilot Study to Assess the Effects of High Frequency Chest Wall Oscillation (HFCWO) Therapy in Patients With Chronic Bronchitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- The Primary Outcome Measure is the Rate of Exacerbations as Defined Using the Winnipeg Criteria.
研究概览
简要总结
The purpose of this study is to show that one form of mechanical airway clearance techniques, High Frequency Chest Wall Oscillation (HFCWO)using a pneumatic vest, will diminish exacerbations of COPD which will improve respiratory health status.
详细描述
Approximately 60 to 70% of people with COPD have chronic cough and phlegm, the cardinal symptoms of chronic bronchitis or chronic mucus hypersecretion (CMH). Once thought to be a relatively benign condition, recent evidence shows that CMH in patients with established COPD is associated with greater decline in lung function, more frequent respiratory infections, more frequent exacerbations and increased mortality.Using mechanical airway clearance techniques (The Vest) will diminish exacerbations of COPD which will improve respiratory health status.
Comparison: Patients randomly assigned to the vest will have fewer exacerbations of COPD,better quality of life and less health care use compared to patients assigned to a sham vest.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physician Diagnosis of COPD,chronic bronchitis and/or emphysema
- •Forced Expiratory Volume in 1 second (FEV1)/ Forced Vital Capacity (FVC) < or = 70%
- •FEV1 < or = 65%
- •Current or former smoker > or = 20 pack years
- •History of 1 or more COPD exacerbations in past 6 months necessitation hospitalization, Emergency Department (ED) visit, antibiotic or steroid prescription
排除标准
- •Other lung diseases
- •Co-morbid illnesses such as cancer, liver disease, cardiomyopathy
- •Recent chest wall or abdominal trauma or surgery that would preclude using the vest
研究组 & 干预措施
Active
Pneumatic Compression Device used twice daily for 20 minutes each time for 12 weeks
干预措施: pneumatic vest (Device)
Sham
Device looked and sounded like a pneumatic compression device, but was not inflating nor deflating.
干预措施: placebo pneumatic vest (Other)
结局指标
主要结局
The Primary Outcome Measure is the Rate of Exacerbations as Defined Using the Winnipeg Criteria.
时间窗: 12 weeks
count of exacerbations per group per 12 weeks. An exacerbation was defined based on three major symptoms: increasing dyspnea, increasing sputum purulence and increasing sputum volume. Exacerbations were counted if there were at least 2 of these 3 symptoms.
次要结局
- Quality of Life(Change from baseline to 12 weeks)