Clinical Effectiveness Of High Frequency Chest Wall Oscillation (HFCWO) In A Bronchiectasis Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 4
- 主要终点
- Quality of Life (QoL): Quality of Life-Bronchiectasis (QOL-B) questionnaire
研究概览
简要总结
The primary objective is to compare the patient's baseline QoL prior to HFCWO use against the patient's QoL at various study timepoints over a one-year period of HFCWO use.
详细描述
This study will use a prospective interventional comparative study design using the patient's quality of life (QoL) as the primary study endpoint to determine HFCWO affect. The study will compare the patient's QoL baseline (established at enrollment prior to HFCWO treatment) to the QoL measured at various timepoints (enrollment, 2 months, 6 months and 12 months) over a one-year period whilst receiving HFCWO treatment. In addition, a baseline for the secondary endpoints will established at enrollment for comparison to measurements taken at various timepoints over a one-year period whilst receiving HFCWO treatment. The patient's medical records will be used to establish prior histories of exacerbation rates for comparison to exacerbation rates experienced after one year of HFCWO treatment. Patients will serve as their own control.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Previous diagnosis of bronchiectasis confirmed by HRCT within the last 6 months
- •Patients must have at least 6 months of medical records related to bronchiectasis
- •Patients must be stable and currently on a standard of care regimen for bronchiectasis such as hypertonic saline and/or PEP
- •Patients with 1 or more exacerbations within the last 12 months
- •Previous and existing productive cough
- •No previous HFCWO use
排除标准
- •Patients who are known to have cystic fibrosis
- •Patients who are known to have primary ciliary dyskinesia (PCD)
- •Patients with chronic obstructive pulmonary disease (COPD) without bronchiectasis
- •Patients breathing via an artificial airway
- •Severe bronchospasm based on exam or history
- •Any comorbidity(ies) or contraindications that would normally complicate tolerating HFCWO treatment
结局指标
主要结局
Quality of Life (QoL): Quality of Life-Bronchiectasis (QOL-B) questionnaire
时间窗: 1 year
The primary endpoint is the subject's quality of life (QoL) using the Quality of Life-Bronchiectasis (QOL-B) questionnaire as the measurement tool. QoL measured at enrollment (baseline) will be compared to QoL measured at 2 months, 6 months and 1 year. The previously validated questionnaire is titled "Quality of Life Questionnaire - Bronchiectasis". The Likert style questionnaire asks the subject to subjectively rank their symptoms using a 4 scale base ranging from "a lot of difficulty" to "no difficulty" and "always" to "never".
次要结局
- Clinical Measurements(1 year)