Evaluation of HFCWO Using The Vest® System for Treatment of Non-Cystic Fibrosis Bronchiectasis in the Home Setting
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 43
- 试验地点
- 5
- 主要终点
- Frequency of acute exacerbations of bronchiectasis
研究概览
简要总结
This a 70 patient multi-site non blinded randomized control trial evaluating the use of the Vest® System for treatment of Non-Cystic Fibrosis Bronchiectasis (NCFBE) patients in the home setting. The study will assess outcomes in subjects requiring airway clearance therapy randomized to Oscillating Positive Expiratory Pressure (OPEP) therapy as the control group and High Frequency Chest Wall Oscillation (HFCWO) therapy as the intervention group
详细描述
Patients with NCFBE who require regular home airway clearance therapy will be eligible to be screened for inclusion in the study.
After enrollment, baseline data including demographics, pulmonary related medical history including acute exacerbations (pulmonary-related hospitalizations, ED visits and physician office visits) will be collected Pulmonary function tests (PFTs) (spirometry), and a six-minute walk test will be completed. Quality of Life measures and inflammatory markers and will be collected.
Patients will be randomized to HFCWO or OPEP therapy. Each device will be used within the approved product labeling. These will be the primary airway clearance devices for these patients during the 12 months of the study period.
Following enrollment in the study and completion of a baseline visit, subjects will be seen for follow-up visits.
Detailed documentation of health status and medical history will be collected during the 12-month study period and/or at each study visit to document the occurrence of acute exacerbations and to determine time to first exacerbation, number of hospitalizations and hospitalization days, number of ICU admissions and ICU days, and number of outpatient visits (Physician's office visit, Urgent Care Visits, ED visits)
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Radiological diagnosis of Bronchiectasis based on high resolution chest CT scan
- •History of at least 2 acute exacerbations or hospitalizations in the past 12 months
- •Clinically stable for >2 weeks prior to study entry
- •FEV1 >30% predicted
- •Age18-80 years
- •Signed informed consent
排除标准
- •Diagnosis of Cystic Fibrosis
- •History of bronchiectasis secondary to primary immunodeficiency
- •Active pulmonary tuberculosis
- •Active treatment of Non-Tuberculous Mycobacterium (NTM)
- •Patients currently on home HFCWO treatment or home HFCWO treatment within the past 24 months
- •Diagnosed comorbidity or medical indication that would prevent study completion
- •History of pneumothorax within past 6 months
- •History of hemoptysis requiring embolization within past 12 months
- •Inability to perform HFCWO therapy or OPEP therapy as directed
- •Pregnancy or lactation
- •Inability or unwillingness to complete study visits or provide follow-up data as required by the study protocol
结局指标
主要结局
Frequency of acute exacerbations of bronchiectasis
时间窗: 12 months
Acute exacerbation periods will be defined as per the European Respiratory Society consensus definition: * A deterioration in three or more of the following key symptoms for at least 48 h: * Cough * Sputum volume and/or consistency * Sputum purulence * Breathlessness and/or exercise tolerance * Fatigue and/or malaise; * Hemoptysis AND * A clinician determines that a change in bronchiectasis treatment is required
次要结局
- 6-minute walk test(12 months)
- Number of exacerbation related ICU admissions(12 months)
- Number of exacerbation related outpatient visits (Physician's office, Urgent Care Visits, ED visits)(12 months)
- Mean adherence to prescribed treatment regimen(12 months)
- Pulmonary function tests(12 months)
- Quality of life measure using the Quality of Life - Bronchiectasis (QoL-B) tool(12 months)
- Time to first exacerbation(12 months)
- Number of exacerbation related hospitalizations(12 months)
- Number of exacerbation related inpatient hospital days(12 months)
- Number of exacerbation related ICU days(12 months)
- Number of courses of antibiotics during episodes of acute exacerbation(12 months)
- Number of antibiotic use days during episodes of acute exacerbation(12 months)
- Bronchiectasis related medication(12 months)